Tarantola et al., 2010; Wu et al., 2010). The EPISAFE program carried out a 10-year retrospective French nationwide study to report the incidence of obstetric and neonatal complications in pregnant women treated with intravitreal VEGF inhibitor and corticosteroid using the French health insurance database (Ben Ghezala et al., 2022). Two hundred twenty-eight VEGF inhibitor or corticosteroid injections were administered to 139 women during pregnancy or in the month preceding pregnancy between 2009 and 2018, of which 93 had VEGF inhibitors, 39 corticosteroids and 7 both drugs. It represented 0.004% of the overall injections (n = 5 672 921) administered over the 10-year study period highlighting that it remains a rare event (Ben Ghezala et al., 2022). The mean (SD) number of injections during pregnancy was 1.6 (1.1). Overall, the analysis found a high prevalence of obstetric complications, with 19.4% and 31.3% of pregnancy hypertensive disorders, 17.7% and 12.5% of fetal distress, and 9.7% and 3.1% of intrauterine growth restriction in patients treated with anti-VEGF agents or corticosteroids, respectively. No significant difference was noticed between either type of drug. The incidence of miscarriage or medical termination of pregnancy tended to be higher in patients treated with VEGF inhibitors than those treated with corticosteroids (16.1% vs 3.1%, respectively, P = 0.09). Using a multivariate statistical model, intravitreal VEGF inhibitor was not associated with a higher risk of obstetric or neonatal complications than corticosteroids. Pregnant women treated with intravitreal therapy in this analysis tended to be older. They had frequent comorbidities such as preexisting diabetes or hypertension, which are known risk factor of high-risk pregnancies independently of the treatment used. Therefore, our study's high rate of obstetric and neonatal complications may be due to the preexisting comorbidities and the older age rather than the intravitreal therapy. Our data are somewhat reassuring, but it is impossible to exclude any relationship between intravitreal treatment and obstetric or neonatal complications observed due to insufficient statistical power. Intravitreal VEGF inhibitors or corticosteroids should continue to be used with caution after carefully assessing the balance between potential benefits and risks in child-bearing age and pregnant women (Ben Ghezala et al., 2022).

# 4. Conclusion and future directions

## 4.1. Big data

The term “big data” is defined by a dataset that is so large that it makes the analysis impossible with classical methods and that requires complex statistical tools. It is known as the 3Vs (volume, velocity and variety), completed by a fourth item, veracity, and sometimes a fifth one, variability. The European Union commission recently defined big data as the following: “Big data in health encompasses high volume, high diversity biological, clinical, environmental and lifestyle information collected from single individuals to large cohorts, about their health and wellness status, at one or several time points” (Auffray et al., 2016). Many datasets have been proposed using either:

* Medical administrative database (Medicare or Medicaid in the US, the French national healthcare system data claim database named “Système National des Données de Santé (SNDS)” in France or Taiwan’s national health insurance research database in Taiwan (Chen et al., 2011)).

* Registries using EMR (IRIS registry or UK electronic medical records) and conventional registries (Fight Retinal Blindness registry) as detailed earlier (Denniston et al., 2019; Gillies et al., 2014b; Nguyen et al., 2021; Parke et al., 2017). The IRIS Registry uses a software tool capable of automatically extracting data from a practice’s EMR system in the US. The FRB registry needs manual input but gathers data from more than 20 countries worldwide.

* Cohort studies can also provide very interesting results by collecting clinical and imaging data from population-based studies, the Constance cohort involving 220 000 individuals (Zins et al., 2010), the

UK biobank including 500 000 individuals (Patel et al., 2016), the European Eye Epidemiology (E3) consortium cohort that gathers more than 15 European population-based studies involving more than 100 000 individuals (Delcourt et al., 2018; Mauschitz et al., 2018)).

All data provided by these studies are interesting and complementary. The main weakness is that associations found in big data studies do not necessarily mean causality. One should remember that a result can be linked to multiple, varying or, even worse, unknown factors (Coleman, 2015). The ultimate goal is to combine both sources of information, for instance, registries and medico administrative databases, using different methods, which will be discussed further below. Although strongly controlled by the general data protection regulation (GDPR), the data can provide information on systemic diseases in patients, that are not always exhaustively collected by registries, as well as social situations and individual data (area of residence, environmental conditions ...). It may be possible to match precise clinical and imaging data collected through a registry with an extensive database. The combination of information sources will dramatically improve our knowledge of patient conditions. Finally, the registry can also provide a control population for hypotheses raised by analysis of the medicoadministrative database. Table 5 summarises and compares the strengths and limitations of the foremost large-scale databases to date.

## 4.2. Linking datasets and harmonising data collection for dataset software interoperability

Linking large-scale datasets is one of the main goals of future developments in RWD. One aim is to establish larger datasets where information from several resources, i.e. several registries, is aggregated to run large-scale analysis. This will better address questions about how a medication is used in real-world practice, where it is delivered and how it is delivered - and what the outcomes associated with treatments are. This might be relevant when outcomes across countries, different reimbursement systems and areas with different access to healthcare are to be compared. Linking imaging to clinical registry outcomes would enable greater data-driven insights and potentially allow more personalised medicine. Another very practical goal, when linking registries is considered, is to connect registries at a clinic level to an existing EMR. The use of EMR has been incentivised in several countries, in some countries it has become mandatory. Considering this, it is reasonable to establish how the information already electronically captured during routine clinical practice can be transformed and transferred into an existing registry. While linking different registries with already established data sets is something that can be achieved today, much work must be done to link registries to existing medical records. There are various ways such a linkage between an existing EMR and an established registry can be achieved.

### 4.2.1. Data mining technologies

One way to gather RWD is by using data mining technologies. Data mining software trawls through existing medical records and examines information about patients that are registered electronically. The software then tries to identify fields/variables and the information/values they contain. This can be done by e.g. identifying visual acuity readings or using codes (e.g. ICD 10), or in some cases information from free text fields. The advantage of this approach is that a huge number of data fields can be analysed and extracted from patient records. This mining method is also less expensive than other approaches. However, the quality of the information collected by data mining technologies is generally inferior to other data sources.

Incomplete datasets, either because the information was not recorded or it is there and could not be read using a data mining approach, are a particular problem of RWD. Only a fraction of patients from the total cohort may have sufficient data to be included in the analysis. One
<table><caption>**Table 5**
Summary and comparison of the strength and weaknesses of the main large-scale databases.</caption><thead><tr><th>Name</th><th>IRIS</th><th>FRBI registry</th><th>Medicare</th><th>UK Biobank</th><th>French SNDS</th></tr></thead><tbody><tr><td>Country</td><td>USA</td><td>International (20 countries)</td><td>USA</td><td>UK</td><td>France</td></tr><tr><td>Type</td><td>Repository</td><td>Registry</td><td>Med Adm DB</td><td>Biomedical base</td><td>Med Adm DB</td></tr><tr><td>Size</td><td>400 million visits</td><td>600 000 visits</td><td>54 million patients with 46 million >65 yo</td><td>500 000 patients</td><td>61 million patients</td></tr><tr><td>Starting date</td><td>2014</td><td>30 000 patients</td><td>1991</td><td>2006</td><td>2007</td></tr><tr><td>Collection</td><td>Directly from EMR or web based</td><td>Directly from EMR or web based</td><td>Summary of billing data</td><td>Biological and clinical data</td><td>Summary of billing data</td></tr><tr><td>Content</td><td>Clinical diagnosis, imaging interpretation</td><td>Clinical diagnosis, imaging interpretation</td><td>Diagnosis and demography</td><td>Clinical examination, blood and urinary samples</td><td>Diagnosis and demography</td></tr><tr><td>Main strengths</td><td>Continuous integration of data<br>Financial incentive<br>Direct feedback<br>Multicentre</td><td>Continuous integration of data<br>Continuious integration of data<br>Direct feedback<br>Quality control<br>Multicentre and international</td><td>Exhaustiveness of data for individual >65 yo<br>Statistical power</td><td>Clinical, biological, genetic and environmental data<br>Imaging collection</td><td>Exhaustiveness of French population data<br>Statistical power</td></tr><tr><td>Main weaknesses</td><td>No randomization<br>No past history<br>No mandatory fields and hence missing data limiting the overall quality of data</td><td>GDPR compliant<br>Manual data entry<br>No randomization<br>No past history</td><td>Data entry influenced by financial valuation of coding</td><td>Selection bias</td><td>Data entry influenced by financial valuation of coding</td></tr><tr><td>Cost</td><td>Very high</td><td>High</td><td>No clinical or biological data<br>Partial information about drug use<br>Population >65 yo<br>Low<sup>a</sup></td><td>High</td><td>No clinical or biological data</td></tr></tbody></table>

USA, United States of America; UK, United Kingdom; Medico administrative database, Med Adm DB, yo, year old; EMR, Electronic medical records.

<sup>a</sup> These analyses use data already available in the public health system.

example is a paper published in 2021 on refractive outcomes after immediate or sequential bilateral cataract surgery (Owen et al., 2021) using the IRIS registry that currently contains approximately 68.5 million unique participants in the United States. Out of the 68.5 million patients, about 4.2 million patients underwent bilateral cataract surgery. Of those 4.2 million individuals, only 43% could eventually be included – for the remaining 57%, no documentation of visual acuity was available. Of the 1.8 million patients with visual acuity recordings, 1.46 million (80%) had a corrected visual acuity test after cataract surgery. So a refracted visual acuity post cataract surgery was only available in 35% of the potentially 4.2 million otherwise eligible patients. This is not unusual, as in routine clinical practice, documentation and postoperative standard procedures in routine clinical practice can vary significantly across institutions, countries and healthcare systems. Visual acuity is not always recorded in a notation that would be needed for an analysis. In another article from 2018 addressing visual acuity outcomes in patients receiving VEGF inhibitors to treat nAMD, approximately 1/3 of eyes included were missing visual acuity values at baseline or one year of treatment (Rao et al., 2018). Again, this does not imply that the doctors did not care well for their patients; it merely reflects what this approach to collect data produces.

Another issue in data mining technologies is when non-uniform ways to report visual acuity or when unique abbreviations are used to document findings. This can be particularly problematic when free text fields are mined, making the data analysis very challenging. Nevertheless, given the scale at which data can be analysed and the impressive number of patients included in such an analysis, this approach is still something to consider.

### 4.2.2. Converting and exporting EMR data to registries

A different approach to link registries to EMR is to export the data from an existing EMR and convert it into a format that can be uploaded to a registry. This can be done in several ways.

One option is to replicate the fields required in a specific registry in the EMR. This is especially necessary if particular fields are needed for the registry that are not part of routine clinical evaluation. As a result, no external software has to travel to the EMR of patients. Still, the user, practice or hospital information technology (IT) service exports the information collected during routine clinical visits, converts it and puts it in a format that can be uploaded or exchanged into a specific registry. This ensures, for instance, the notation of visual acuity adheres to specific agreed standards, as well as the reporting of intraocular pressure or other findings. The great advantage of this approach is that the data quality is generally very high. Data quality is higher if key fields are mandatory. If this principle is followed, practically all key data on every patient entered into the EMR will be transferred to the registry. The disadvantage of this approach is that it is cost- and labour-intensive to set up due to the adaptations to the local EMR that are required. This usually has to be done in conjunction with hospital or practice IT. If any changes are made to the data that the registry wishes to collect, the local EMR needs to be adapted again. Another potential disadvantage is that participation in several registries can become very tricky. An example of this approach is the Swedish macula register or the FRB! registry, which track fewer patients but provide higher quality datasets than the IRIS registry.

### 4.2.3. Data collection standardisation for electronic medical record software interoperability

As we can see, each of the two approaches outlined - using data mining technologies without changing the local software or making adaptations to the local software, producing standardised output and submitting to a registry - has pros and cons: technically, financially and with respect to data quality. The increasing presence of technology and the need to connect electronic devices handling patient information has created a demand for a more uniform approach to exchanging data. The ideal solution would be one that would work in many places and would
be a commonly agreed standard on how data is collected and how it is
exchanged.

Interoperability is something that many groups around the world are working on; the leading institution is Health Level Seven International (HL7, information available at http://www.hl7.org/index.cfm). Under HL7's guidance, a standard was established and named Fast Healthcare Interoperability Resources (FHIR, pronounced "fire"). This standard describes data formats and elements and their respective application programming interfaces to allow exchange between EMRs. The first implementation guide for Ophthalmology was published in August 2021 (more information at http://build.fhir.org/ig/HL7/fhir-eyecare-ig/).

All software and databases that are FHIR-enabled will be able to exchange information in the same way. In several countries, such as the US, France, Netherlands, Austria and Switzerland, national health authorities have focused on implementing these harmonisation strategies in their national health networks and establishing FIHR as one of the critical components of interoperability (Brandstätter, 2020; Economic cooperation and development, 2021; US congress, 2010).

There are many activities worldwide moving towards the common goal of achieving interoperability. Apart from the technical issues of standardisation, implementation and dealing with an ever-changing IT landscape, questions concerning patient data protection, privacy, anonymity, or data usage for research have to be taken into account and warrant discussion. Once established, FIHR will be an excellent way to provide information from an EMR to a registry. It will be up to the user to make sure that the data collected primarily in clinics or practices will be of good quality (e.g. by introducing mandatory fields or other quality assurance measures) to avoid the lower quality data produced by data mining.

The establishment of a standard such as FIHR will not only linkage of registries and EMRs but also patients access to their health information, thereby involving them more deeply in the therapeutic process which will improve treatment adherence and, in turn, outcomes. Apple has implemented FIHR in their smartphone's health app (information at https://www.apple.com/healthcare/health-records/), and Google published their Android FIHR software development kit (information available at https://github.com/google/android-fhir) providing the basis to access health-related information on a smartphone.

4.3. *Applying artificial intelligence algorithms to registry data*

The advancement of computing power and image analysis algo-
rithms has opened up opportunities to connect registry data with clinical
images. This linkage can enhance image analysis by incorporating
clinical outcomes, improving patient treatment understanding, and
optimizing real-world care. Traditional automated analyses of retinal
and OCT images primarily focused on data from controlled settings like
randomized clinical trials. These settings provided high-quality images
but had limited applicability in real-world practice. Recent de-
velopments have enabled the transition from study data to clinical
practice data, benefiting patients in remote areas with limited access to
specialists.

OCT has become the primary imaging tool in ophthalmology due to its speed and detailed retinal cross-sections. Algorithms are being developed to automatically interpret OCT images, predict treatment needs, and detect changes in retinal structure, mirroring the shift seen in fundus photograph analysis (De Fauw et al., 2018; Gallardo et al., 2021; Schlegl et al., 2018; Schmidt-Erfurth et al., 2022). Similar to the development applied to the analysis of fundus photographs, a move from analysing OCT data from randomised trials to real-world clinical data is also afoot.

One of the first of these algorithms that has been approved for
clinical use by the European Marking medical device regulation (MRD-
CE) is the Vienna fluid monitor (information available at https://retin
sight.com). This algorithm works with routinely acquired OCT images
to detect fluid in various compartments (Schmidt-Erfurth et al., 2022).

As our knowledge of treating diseases such as macular degeneration quickly evolves, and it becomes evident that fluid in different compartments can affect visual acuity outcomes depending on their location, it may become even more necessary to have automated tools that support decision-making and help to identify changes in the retinal structure. Other companies such as Notal Vision (Tel Aviv, Israel; information available at https://notalvision.com) or RetinAI (Bern, Switzerland; information available at https://www.retinai.com) provide algorithms that also detect changes in retinal structure and can be used to alert or inform doctors and patients automatically. RetinAI received FDA clearance in May 2022 for their RetinAI Discovery product. However, practicality, technology effectiveness, and disease-specific algorithms still need assessment. Validation in real-world settings is crucial to avoid missing sight-threatening conditions. Legal, privacy, and data protection issues may pose challenges in implementing these algorithms in routine clinical practice.

In summary, AI holds promise for enhancing patient care, but challenges remain in ensuring real-world applicability and addressing legal and privacy concerns.

4.4. *Conclusion*

RWE has provided valuable insights into the optimal management of DMO. One key insight from RWD was the effectiveness and safety of key intravitreal drugs, such as VEGF inhibitors and steroids, in routine clinical practice for the treatment of DMO. Even if treatment outcomes have significantly improved with time related to better knowledge and change in practice patterns, a ceiling effect appears to have been reached in what can be achieved in terms of effectiveness using approved therapy for DMO in the real world, which remains inferior to RCTs. Real-world settings may have more variability in how the treatment is administered, leading to poorer results since sicker patients with more comorbidities may not receive the same amount of treatment and monitoring as those in clinical trials. RWE reported that treating earlier (when VA decreases below 80 logMAR letters or 8/10 Monoyer chart or 20/25 Snellen chart) and intensive and personalised dosing, such as T&E, can refine long-term outcomes in DMO, while decreasing the burden for patients and improving compliance by optimizing the number of injections and visits. Novel target therapeutics or promising new longer-acting drug agents or devices are under investigation, such as the port delivery system, or have been recently approved for DMO, such as brolucizumab, farcimab or high-dose aflibercept, with effectiveness that is non-inferior to conventional, approved treatment with longer intervals between injections as well as more effective drying of retinal fluid. Their introduction in our daily practice may address some of the unmet need in managing our patients with poorly responsive DMO. RWD will confirm not only whether they are effective in daily practice, but also provide valuable safety data since registrational trials are not sufficiently powered enough to detect rare ocular adverse events. Finally, RWD analysis will benefit from new powerful technologies, such as AI, big data and software that supports dataset linkage, which will enhance the ability to analyse RWD to aid diagnosis, treatment decisions and provide prognostic information to further improve the management of DME.

Grants/funding

None.

Authors statement

All authors have contributed to the content of the manuscript as
detailed below:

Pierre-Henry Gabrielle: contributed to the concept, outline, writing, critical review and editing, montaging of images and final approval of the manuscript.
Hemal Mehta: contributed to outline, writing, critical review and editing and final approval of the manuscript.

Daniel Barthelmes: contributed to outline, writing, critical review to sections of the paper and final approval of the manuscript.

Vincent Daien: contributed to writing, critical review to sections of the paper and final approval of the manuscript.

Vuong Nguyen: contributed to writing, critical review to sections of the paper and final approval of the manuscript.

Mark C. Gillies: contributed to the concept, outline, writing, critical review to sections of the paper and final approval of the manuscript.

Catherine Creuzot-Garcher: contributed to the concept, outline, writing, critical review to sections of the paper and final approval of the manuscript.

Percentage of work contributed by each author in the production of the manuscript is as follows: Pierre-Henry Gabrielle: 35%; Hemal Mehta: 20%; Daniel Barthelmes: 10%; Vincent Daien: 5%; Vuong Nguyen: 10%; Mark C. Gillies: 10%; Catherine Creuzot-Garcher: 10%.

## Declaration of competing interest

PHG: consultant for Novartis, Bayer, Roche, Horus Pharma and Zeiss; HM: consultant for Allergan/Abbvie, Bayer, Novartis and Roche; DB: received research grants and travel expenses for Bayer and Novartis and consultant for Alcon; VD: consultant for Horus Pharma and Théa Pharma; VN: None; MG: received grants from NHMRC, grants from RANZCO Eye Foundation, grants and others from Novartis, and grants and others from Bayer; CCG: consultant for Allergan/AbbVie, Bayer, Horus Pharma, Novartis, Roche, Alcon and Théa Pharma.

## Data availability

No data was used for the research described in the article.

## References

Abdel-Qadir, H., Ethier, J.-L., Lee, D.S., Thavendiranathan, P., Amir, E., 2017. Cardiovascular toxicity of angiogenesis inhibitors in treatment of malignancy: a systematic review and meta-analysis. Cancer Treat Rev. 53, 120-127. https://doi.org/10.1016/j.ctrv.2016.12.002.

Aiello, L.P., 2005. Angiogenic pathways in diabetic retinopathy. N. Engl. J. Med. 353, 839-841. https://doi.org/10.1056/NEJMe058142.

Al Qassimi, N., Kozak, I., Al Karam, M., Neri, P., Aduriz-Lorenzo, P.M., Attawan, A., Awadalla, M., El Khashab, A., Abdul-Nabi, M., Safar, A., Al Shamsi, H., Rao, P., Rao, M., Farid, A., Gurbaxani, A., Emirates Society of Ophthalmology, 2022. Management of diabetic macular edema: guidelines from the Emirates society of ophthalmology. Ophthalmol. Ther. 11, 1937-1950. https://doi.org/10.1007/s40123-022-00547-2.

Amoaku, W.M.K., Saker, S., Stewart, E.A., 2015. A review of therapies for diabetic macular oedema and rationale for combination therapy. Eye (Lond) 29, 1115-1130. https://doi.org/10.1038/eye.2015.110.

Amoaku, W.M., Ghanchi, F., Bailey, C., Banerjee, Sanjiv, Banerjee, Somnath, Downey, L., Gale, R., Hamilton, R., Khunti, K., Posner, E., Quhill, F., Robinson, S., Setty, R., Sim, D., Varma, D., Mehta, H., 2020. Diabetic retinopathy and diabetic macular oedema pathways and management: UK Consensus Working Group. Eye (Lond) 34, 1-51. https://doi.org/10.1038/s41433-020-0961-6.

Arnold, J.J., Campain, A., Barthelmes, D., Simpson, J.M., Guymer, R.H., Hunyor, Alex P., McAllister, I.L., Essex, R.W., Morlet, N., Gillies, M.C., Hunt, A., Gillies, M., Hunt, A., Hunyor, A.P., Arnold, J., Young, S., Clark, G., Banerjee, G., Phillips, R., Perks, M., Essex, R., McAllister, I., Constable, I., Guymer, R., Guymer, R., Lim, L., Harper, A., Chow, L.P., Wickremansinghe, S., Wickremasinghe, S., Wickremasinghe, S., 2015. Two-year outcomes of "treat and extend" intravitreal therapy for neovascular age-related macular degeneration. Ophthalmology 122, 1212-1219. https://doi.org/10.1016/j.ophtha.2015.02.009.

Atchison, E.A., Wood, K.M., Mattox, C.G., Barry, C.N., Lum, F., MacCumber, M.W., 2018. The real-world effect of intravitreous anti-vascular endothelial growth factor drugs on intraocular pressure: an analysis using the IRIS registry. Ophthalmology 125, 676-682. https://doi.org/10.1016/j.ophtha.2017.11.027.

Auffray, C., Balling, R., Barroso, I., Bencze, L., Benson, M., Bergeron, J., Bernal-Delgado, E., Blomberg, N., Bock, C., Conesa, A., Del Signore, S., Delogne, C., Devilee, P., Di Meglio, A., Eijkemans, M., Flicek, P., Graf, N., Grimm, V., Guchelaar, H.-J., Guo, Y.-K., Gut, I.G., Hanbury, A., Hanif, S., Hilgers, R.-D., Honrado, A., Hose, D.R., Houwing-Duistermaat, J., Hubbard, T., Janacek, S.H., Karanikas, H., Kievits, T., Kohler, M., Kremer, A., Lanfear, J., Lengauer, T., Maes, E., Meert, T., Müller, W., Nickel, D., Oledzki, P., Pedersen, B., Petkovic, M., Pliakos, K., Rattray, M., i Más, J.R., Schneider, R., Sengstag, T., Serra-Picamal, X., Spek, W.,

Vaas, L.A.I., van Batenburg, O., Vandelær, M., Varnai, P., Villoslada, P., Vizcaíno, J. A., Wubbe, J.P.M., Zanetti, G., 2016. Making sense of big data in health research: towards an EU action plan. Genome Med. 8, 71. https://doi.org/10.1186/s13073-016-0323-y.

Avery, R.L., Gordon, G.M., 2016. Systemic safety of prolonged monthly anti-vascular endothelial growth factor therapy for diabetic macular edema: a systematic review and meta-analysis. JAMA Ophthalmol. 134, 21-29. https://doi.org/10.1001/jamaophthalmol.2015.4070.

Azur, M.J., Stuart, E.A., Frangakis, C., Leaf, P.J., 2011. Multiple imputation by chained equations: what is it and how does it work? Int. J. Methods Psychiatr. Res. 20, 40-49. https://doi.org/10.1002/mpr.329.

Bailey, C., Chakravarthy, U., Lotery, A., Menon, G., Talks, J., Medisoft Audit Group, 2022. Extended real-world experience with the ILUVIEN® (fluocinolone acetonide) implant in the United Kingdom: 3-year results from the Medisoft® audit study. Eye (Lond) 36, 1012-1018. https://doi.org/10.1038/s41433-021-01542-w.

Baker, C.W., Almukhtar, T., Bressler, N.M., Glassman, A.R., Grover, S., Kim, S.J., Murtha, T.J., Rauser, M.E., Stockdale, C., 2013. Macular edema after cataract surgery in eyes without pre-operative central-involved diabetic macular edema. JAMA Ophthalmol. 131, 870-879. https://doi.org/10.1001/jamaophthalmol.2013.2313.

Baker, C.W., Glassman, A.R., Beaulieu, W.T., Antoszyk, A.N., Browning, D.J., Chalam, K. V., Grover, S., Jampol, L.M., Jhaveri, C.D., Melia, M., Stockdale, C.R., Martin, D.F., Sun, J.K., 2019. Effect of initial management with aflibercept vs laser photocoagulation vs observation on vision loss among patients with diabetic macular edema involving the center of the macula and good visual acuity: a randomized clinical trial. JAMA 321, 1880-1894. https://doi.org/10.1001/jama.2019.5790.

Bansal, R., Bansal, P., Kulkarni, P., Gupta, V., Sharma, A., Gupta, A., 2011. Wandering Ozurdex® implant. J. Ophthalmic. Inflamm. Infect. 2, 1-5. https://doi.org/10.1007/s12348-011-0042-x.

Baudin, F., Benzenine, E., Mariet, A.-S., Bron, A.M., Daien, V., Korobelnik, J.F., Quantin, C., Creuzot-Garcher, C., 2018. Association of acute endophthalmitis with intravitreal injections of corticosteroids or anti-vascular growth factor agents in a nationwide study in France. JAMA Ophthalmol. 136, 1352-1358. https://doi.org/10.1001/jamaophthalmol.2018.3939.

Baudin, F., Benzenine, E., Mariet, A.-S., Ghezala, I.B., Bron, A.M., Daien, V., Gabrielle, P.-H., Quantin, C., Creuzot-Garcher, C., 2022. Topical antibiotic prophylaxis and intravitreal injections: impact on the incidence of acute endophthalmitis—a nationwide study in France from 2009 to 2018. Pharmaceutics 14, 2133. https://doi.org/10.3390/pharmaceutics14102133.

Beaulieu, W.T., Glassman, A.R., Baker, C.W., Maguire, M.G., Johnson, C.A., Melia, M., Sun, J.K., 2021. Effect of initial aflibercept, laser, or observation on low-contrast visual acuity in eyes with diabetic macular edema and good vision: ancillary study within a randomized clinical trial. Transl. Vis. Sci. Technol. 10, 3. https://doi.org/10.1167/tvst.10.3.3.

Ben Ghezala, I., Mariet, A.-S., Benzenine, E., Bardou, M., Bron, A.M., Gabrielle, P.-H., Baudin, F., Quantin, C., Creuzot-Garcher, C., 2022. Association between obstetric complications and intravitreal anti-vascular endothelial growth factor agents or intravitreal corticosteroids. J. Personalized Med. 12, 1374. https://doi.org/10.3390/jpm12091374.

Berger, M.L., Sox, H., Willke, R.J., Brixner, D.L., Eichler, H., Goettsch, W., Madigan, D., Makady, A., Schneeweiss, S., Tarricone, R., Wang, S.V., Watkins, J., Daniel Mullins, C., 2017. Good practices for real-world data studies of treatment and/or comparative effectiveness: recommendations from the joint ISPOR-ISPE Special Task Force on real-world evidence in health care decision making. Pharmacoepidemiol. Drug Saf. 26, 1033-1039. https://doi.org/10.1002/pds.4297.

Bertelsen, G., Peto, T., Lindekleiv, H., Schirmer, H., Solbu, M.D., Toft, I., Sjølie, A.K., Njølstad, I., 2013. Tromso eye study: prevalence and risk factors of diabetic retinopathy. Acta Ophthalmol. 91, 716-721. https://doi.org/10.1111/j.1755-3768.2012.02542.x.

Bhandari, S., Nguyen, V., Fraser-Bell, S., Mehta, H., Viola, F., Baudin, F., Gabrielle, P.-H., Creuzot-Garcher, C., Gillies, M., Barthelmes, D., 2019. Ranibizumab or aflibercept for diabetic macular edema: comparison of 1-year outcomes from the fight retinal blindness! Registry. Ophthalmology. https://doi.org/10.1016/j.ophtha.2019.11.018.

Bhandari, S., Biechl, A.C., Nguyen, V., Squirreld, R., Mehta, H., Barthelmes, D., Gillies, M. C., 2020. Outcomes of cataract surgery in eyes with diabetic macular oedema: data from the Fight Retinal Blindness! Registry. Clin. Exp. Ophthalmol. 48, 462-469. https://doi.org/10.1111/ceo.13707.

Bhandari, S., Squirreld, R., Nguyen, V., Wang, N., Wells, J.M., Tan, T., Barnes, R., Barry, R., Barthelmes, D., Gillies, M., 2021. Bevacizumab for diabetic macular oedema: one-year treatment outcomes from the Fight Retinal Blindness! Registry. Eye. https://doi.org/10.1038/s41433-021-01509-x, 1-9.

Bhandari, S., Gabrielle, P.-H., Nguyen, V., Daien, V., Viola, F., Bougama, W., Young, S., Romero-Nunez, B., Figueras-Roca, M., Zarranz-Ventura, J., Barthelmes, D., Sararols, L., Gillies, M., Creuzot-Garcher, C., 2022a. Dexamethasone implant for diabetic macular oedema: 1-year treatment outcomes from the fight retinal blindness! Registry. Ophthalmol. Ther. 11, 797-810. https://doi.org/10.1007/s40123-022-00473-3.

Bhandari, S., Nguyen, V., Hunt, A., Gabrielle, P.-H., Viola, F., Mehta, H., Manning, L., Squirreld, R., Arnold, J., McAllister, I.L., Barthelmes, D., Gillies, M., 2022b. Changes in 12-month outcomes over time for age-related macular degeneration, diabetic macular oedema and retinal vein occlusion. Eye. https://doi.org/10.1038/s41433-022-02075-6.

Bhavsar, A.R., Stockdale, C.R., Ferris, F.L., Brucker, A.J., Bressler, N.M., Glassman, A.R., 2012. Update on risk of endophthalmitis after intravitreal drug injections and
potential impact of elimination of topical antibiotics. Arch. Ophthalmol. 130, 809-810. https://doi.org/10.1001/archophthalmol.2012.227.

Biechle, A.C., Bhandari, S., Nguyen, V., Arnold, J.J., Young, S., Fraser-Bell, S., Mehta, H., Gillies, M., Barthelmes, D., 2020. Changes in real-world treatment patterns for diabetic macular oedema from 2009 to 2019 and 5-year outcomes: data from the Fight Retinal Blindness! Registry. Clin. Exp. Ophthalmol. 48, 802-812. https://doi.org/10.1111/ceo.13781.

Bolz, M., Lammer, J., Deak, G., Pollreisz, A., Mitsch, C., Scholda, C., Kundi, M., Schmidt-Erfurth, U., Diabetic Retinopathy Research Group Vienna, 2014. SAVE: a grading protocol for clinically significant diabetic macular oedema based on optical coherence tomography and fluorescence angiography. Br. J. Ophthalmol. 98, 1612-1617. https://doi.org/10.1136/bjophthalmol-2013-304564.

Boyer, D.S., Faber, D., Gupta, S., Patel, S.S., Tabandeh, H., Li, X.-Y., Liu, C.C., Lou, J., Whitcup, S.M., Group, for the O.C.S., 2011. Dexamethasone intravitreal implant for treatment of diabetic macular edema in vitreotomized patients. Retina 31, 915-923. https://doi.org/10.1097/IAE.0b013e1820618d1c.

Boyer, D.S., Yoon, Y.H., Belfort, R., Bandello, F., Maturi, R.K., Augustin, A.J., Li, X.-Y., Cui, H., Hashad, Y., Whitcup, S.M., Ozurdex MEAD Study Group, 2014. Three-year, randomized, sham-controlled trial of dexamethasone intravitreal implant in patients with diabetic macular edema. Ophthalmology 121, 1904-1914. https://doi.org/10.1016/j.ophtha.2014.04.024.

Boyer, D.S., Nguyen, Q.D., Brown, D.M., Basu, K., Ehrlich, J.S., RIDE and RISE Research Group, 2015. Outcomes with as-needed ranibizumab after initial monthly therapy: long-term outcomes of the phase III RIDE and RISE trials. Ophthalmology 122, 2504-2513.e1. https://doi.org/10.1016/j.ophtha.2015.08.006.

Brandstätter, J., 2020. eHealth Suisse - Overview of IHE/HL7/FHIR.

Bressler, N.M., Edwards, A.R., Antoszyk, A.N., Beck, R.W., Browning, D.J., Ciardella, A. P., Danis, R.P., Elman, M.J., Friedman, S.M., Glassman, A.R., Gross, J.G., Li, H.K., Murtha, T.J., Stone, T.W., Sun, J.K., 2008. Retinal thickness on stratus optical coherence tomography in people with diabetes and minimal or No diabetic retinopathy. Am. J. Ophthalmol. 145, 894-901.e1. https://doi.org/10.1016/j.ajo.2007.12.025.

Bressler, S.B., Qin, H., Beck, R.W., Chalam, K.V., Kim, J.E., Melia, M., Wells, J.A., Diabetic Retinopathy Clinical Research Network, 2012. Factors associated with changes in visual acuity and central subfield thickness at 1 year after treatment for diabetic macular edema with ranibizumab. Arch. Ophthalmol. 130, 1153-1161. https://doi.org/10.1001/archophthalmol.2012.1107.

Bressler, N.M., Varma, R., Doan, Q.V., Gleeson, M., Danese, M., Bower, J.K., Selvin, E., Dolan, C., Fine, J., Colman, S., Turpcu, A., 2014. Underuse of the health care system by persons with diabetes mellitus and diabetic macular edema in the United States. JAMA Ophthalmol. 132, 168-173. https://doi.org/10.1001/jamaophthalmol.2013.6426.

Bressler, S.B., Baker, C.W., Almukhtar, T., Bressler, N.M., Edwards, P.A., Glassman, A.R., Scott, M.H., 2014. Pilot study of individuals with diabetic macular edema undergoing cataract surgery. JAMA Ophthalmol. 132, 224. https://doi.org/10.1001/jamaophthalmol.2013.6209.

Bressler, S.B., Melia, M., Glassman, A.R., Almukhtar, T., Jampol, L.M., Shami, M., Berger, B.B., Bressler, N.M., 2015. Ranibizumab prior to prompt or deferred laser for diabetic macular edema in eyes with vitrectomy plus to anti-vascular endothelial growth factor therapy. Retina 35, 2516-2528. https://doi.org/10.1097/IAE.0000000000000617.

Bressler, S.B., Ayala, A.R., Bressler, N.M., Melia, M., Qin, H., Ferris, F.L., Flaxel, C.J., Friedman, S.M., Glassman, A.R., Jampol, L.M., Rauser, M.E., Diabetic Retinopathy Clinical Research Network, 2016a. Persistent macular thickening after ranibizumab treatment for diabetic macular edema with vision impairment. JAMA Ophthalmol. 134, 278-285. https://doi.org/10.1001/jamaophthalmol.2015.5346.

Bressler, S.B., Glassman, A.R., Almukhtar, T., Bressler, N.M., Ferris, F.L., Googe, J.M., Gupta, S.K., Jampol, L.M., Melia, M., Wells, J.A., 2016b. Five-year outcomes of ranibizumab with prompt or deferred laser versus laser or triamcinolone plus deferred ranibizumab for diabetic macular edema. Am. J. Ophthalmol. 164, 57-68. https://doi.org/10.1016/j.ajo.2015.12.025.

Bressler, N.M., Beaulieu, W.T., Glassman, A.R., Blinder, K.J., Bressler, S.B., Jampol, L.M., Melia, M., Wells, J.A., 2018. Persistent macular thickening following intravitreal aflibercept, bevacizumab, or ranibizumab for central-involved diabetic macular edema with vision impairment: a secondary analysis of a randomized clinical trial. JAMA Ophthalmol. 136, 257-269. https://doi.org/10.1001/jamaophthalmol.2017.6565.

Brown, D.M., Nguyen, Q.D., Marcus, D.M., Boyer, D.S., Patel, S., Feiner, L., Schlottmann, P.G., Rundle, A.C., Zhang, J., Rubio, R.G., Adams, A.P., Ehrlich, J.S., Hopkins, J.J., RIDE and RISE Research Group, 2013. Long-term outcomes of ranibizumab therapy for diabetic macular edema: the 36-month results from two phase III trials: RISE and RIDE. Ophthalmology 120, 2013-2022. https://doi.org/10.1016/j.ophtha.2013.02.034.

Brown, D.M., Schmidt-Erfurth, U., Do, D.V., Holz, F.G., Boyer, D.S., Midena, E., Heier, J. S., Terasaki, H., Kaiser, P.K., Marcus, D.M., Nguyen, Q.D., Jaffe, G.J., Slakter, J.S., Simader, C., Soo, Y., Schmelter, T., Yancopoulos, G.D., Stahl, N., Vitti, R., Berliner, A.J., Zeitz, O., Metzig, C., Korobelnik, J.-F., 2015. Intravitreal aflibercept for diabetic macular edema: 100-week results from the VISTA and VIVID studies. Ophthalmology 122, 2044-2052. https://doi.org/10.1016/j.ophtha.2015.06.017.

Brown, D.M., Ou, W.C., Wong, T.P., Kim, R.Y., Croft, D.E., Wykoff, C.C., 2018. Targeted retinal photocoagulation for diabetic macular edema with peripheral retinal nonperfusion: three-year randomized DAVE trial. Ophthalmology 125, 683-690. https://doi.org/10.1016/j.ophtha.2017.11.026.

Brown, D.M., Emanuelli, A., Bandello, F., Barranco, J.J.E., Figueira, J., Souied, E., Wolf, S., Gupta, V., Ngah, N.F., Liew, G., Tuli, R., Tadayoni, R., Dhoot, D., Wang, L., Bouillaud, E., Wang, Y., Kovacic, L., Guerard, N., Garweg, J.G., 2022. KESTREL and

KITE: 52-week results from two phase III pivotal trials of brolucizumab for diabetic macular edema. Am. J. Ophthalmol. 238, 157-172. https://doi.org/10.1016/j.ajo.2022.01.004.

Busch, C., Fraser-Bell, S., Iglicki, M., Lupidi, M., Couturier, A., Chaikitmongkol, V., Giancipoli, E., Rodríguez-Valdés, P.J., Gabrielle, P.-H., Laíns, I., Santos, A.R., Cebeci, Z., Amphornphruet, A., Degenhardt, V., Unterlauft, J.-D., Cagini, C., Mané-Taya, V., D'Amico Ricci, G., Hindi, I., Agrawal, K., Chhablani, J., Loewenstein, A., Zur, D., Rehak, M., International Retina Group, 2019a. Real-world outcomes of non-responding diabetic macular edema treated with continued anti-VEGF therapy versus early switch to dexamethasone implant: 2-year results. Acta Diabetol. 56, 1341-1350. https://doi.org/10.1007/s00592-019-01416-4.

Busch, C., Fraser-Bell, S., Zur, D., Rodríguez-Valdés, P.J., Cebeci, Z., Lupidi, M., Fung, A. T., Gabrielle, P.-H., Giancipoli, E., Chaikitmongkol, V., Okada, M., Laíns, I., Santos, A.R., Kunavisarut, P., Sala-Puigdollers, A., Chhablani, J., Ozimek, M., Hilely, A., Unterlauft, J.D., Loewenstein, A., Iglicki, M., Rehak, M., International Retina Group, 2019b. Real-world outcomes of observation and treatment in diabetic macular edema with very good visual acuity: the OBTAIN study. Acta Diabetol. 56, 777-784. https://doi.org/10.1007/s00592-019-01310-z.

Callanan, D.G., Gupta, S., Boyer, D.S., Ciulla, T.A., Singer, M.A., Kuppermann, B.D., Liu, C.-C., Li, X.-Y., Handerl, D.A., Schiffman, R.M., Whitcup, S.M., 2013. Dexamethasone intravitreal implant in combination with laser photocoagulation for the treatment of diffuse diabetic macular edema. Ophthalmology 120, 1843-1851. https://doi.org/10.1016/j.ophtha.2013.02.018.

Callanan, D.G., Loewenstein, A., Patel, S.S., Massin, P., Corcóstegui, B., Li, X.-Y., Jiao, J., Hashad, Y., Whitcup, S.M., 2017. A multicenter, 12-month randomized study comparing dexamethasone intravitreal implant with ranibizumab in patients with diabetic macular edema. Graefes Arch. Clin. Exp. Ophthalmol. 255, 463-473. https://doi.org/10.1007/s00417-016-3472-1.

Campochiaro, P.A., Akhaq, A., 2021. Sustained suppression of VEGF for treatment of retinal/choroidal vascular diseases. Prog. Retin. Eye Res. 83, 100921 https://doi.org/10.1016/j.preteyes.2020.100921.

Campochiaro, P.A., Brown, D.M., Awh, C.C., Lee, S.Y., Gray, S., Saroj, N., Murahashi, W. Y., Rubio, R.G., 2011a. Sustained benefits from ranibizumab for macular edema following central retinal vein occlusion: twelve-month outcomes of a phase II study. Ophthalmology 118, 2041-2049. https://doi.org/10.1016/j.ophtha.2011.02.038.

Campochiaro, P.A., Brown, D.M., Pearson, A., Ciulla, T., Boyer, D., Holz, F.G., Tolentino, M., Gupta, A., Duarte, L., Madreperla, S., Gonder, J., Kapik, B., Billman, K., Kane, F.E., 2011b. Long-term benefit of sustained-delivery fluocinolone acetonide vitreous inserts for diabetic macular edema. Ophthalmology 118, 626-635.e2. https://doi.org/10.1016/j.ophtha.2010.12.028.

Campochiaro, P.A., Brown, D.M., Pearson, A., Chen, S., Boyer, D., Ruiz-Moreno, J., Garretson, B., Gupta, A., Hariprasad, S.M., Bailey, C., Reichel, J., Soubrange, G., Kapik, B., Billman, K., Kane, F.E., Green, K., 2012. Sustained delivery fluocinolone acetonide vitreous inserts provide benefit for at least 3 Years in patients with diabetic macular edema. Ophthalmology 119, 2125-2132. https://doi.org/10.1016/j.ophtha.2012.04.030.

Cantrell, R.A., Lum, F., Chia, Y., Morse, L.S., Rich, W.L., Salman, C.A., Willis, J.R., 2020. Treatment patterns for diabetic macular edema: an intelligent research in sight (IRIS®) registry analysis. Ophthalmology 127, 427-429. https://doi.org/10.1016/j.ophtha.2019.10.019.

Capuano, V., Srour, M., Miere, A., Guenoun, S., Astroz, P., Semoun, O., Souied, E.H., Querues, G., 2018. Advanced proliferative diabetic retinopathy during pregnancy. J. Fr. Ophthalmol. 41, e485-e487. https://doi.org/10.1016/j.jfo.2018.03.019.

Castro Farías, D., Matsui Serrano, R., Bianchi Gancharou, J., de Dios Cuadras, U., Sahel, J., Graue Wiechers, F., Dupas, B., Paques, M., 2020. Indocyanine green angiography for identifying telangiectatic capillaries in diabetic macular oedema. Br. J. Ophthalmol. 104, 509-513. https://doi.org/10.1136/bjophthalmol-2019-314355.

Chalam, K.V., Bressler, S.B., Edwards, A.R., Berger, B.B., Bressler, N.M., Glassman, A.R., Grover, S., Gupta, S.K., Nielsen, J.S., Diabetic Retinopathy Clinical Research Network, 2012. Retinal thickness in people with diabetes and minimal or no diabetic retinopathy: heidelberg Spectralis optical coherence tomography. Invest. Ophthalmol. Vis. Sci. 53, 8154-8161. https://doi.org/10.1167/iovs.12-10290.

Charlot, A., Baudin, F., Tessier, M., Lebrize, S., Hurand, V., Megroian, D., Arnould, L., Ben-Ghezala, I., Bron, A.M., Gabrielle, P.-H., Creuzot-Garcher, C., 2022. Mobile telemedicine screening for diabetic retinopathy using nonmydrician fundus photographs in burgundy: 11 Years of results. J. Clin. Med. 11, 1318. https://doi.org/10.3390/jcm11051318.

Chatziralli, I., Theodossiadis, P., Parikakis, E., Dimitriou, E., Xirou, T., Theodossiadis, G., Kabanarou, S.A., 2017. Dexamethasone intravitreal implant in diabetic macular edema: real-life data from a prospective study and predictive factors for visual outcome. Diabetes Ther. 8, 1393-1404. https://doi.org/10.1007/s13300-017-0332-x.

Chen, Y.-C., Yeh, H.-Y., Wu, J.-C., Haschler, I., Chen, T.-J., Wetter, T., 2011. Taiwan's National Health Insurance Research Database: administrative health care database as study object in bibliometrics. Scientometrics 86, 365-380. https://doi.org/10.1007/s11192-010-0289-2.

Cheung, C.M.G., Fawzi, A., Teo, K.Y.C., Fukuyama, H., Sen, S., Tsai, W.-S., Sivaprasad, S., 2022. Diabetic macular ischaemia- a new therapeutic target? Prog. Retin. Eye Res. 89, 101033 https://doi.org/10.1016/j.preteyes.2021.10.1033.

Chia, E.-M., Wang, J.J., Rochtchina, E., Smith, W., Cumming R.R., Mitchell, P., 2004. Impact of bilateral visual impairment on health-related quality of life: the blue mountains eye study. Invest. Ophthalmol. Vis. Sci. 45, 71-76. https://doi.org/10.1167/iovs.03-0661.

Chia, M.A., Taylor, J.R., Stuart, K.V., Khawaja, A.P., Foster, P.J., Keane, P.A., Turner, A. W., 2023. Prevalence of diabetic retinopathy in indigenous and non-indigenous
Australians: a systematic review and meta-analysis. Ophthalmology 130, 56–67.
https://doi.org/10.1016/j.ophtha.2022.07.024.

Chiang, M.F., Sommer, A., Rich, W.L., Lum, F., Parke, D.W., 2018. The 2016 American Academy of ophthalmology and methods. Ophthalmology 125, 1143–1148. https://doi.org/10.1016/j.ophtha.2017.12.001.

Chin, H.-S., Park, T.-S., Moon, Y.-S., Oh, J.-H., 2005. Difference in clearance of intravitreal triamcinolone acetonide between vitrectomized and nonvitrectomized eyes. Retina 25, 556–560.

Ciulla, T.A., Starr, M.B., Masket, S., 2002. Bacterial endophthalmitis prophylaxis for cataract surgery: an evidence-based update. Ophthalmology 109, 13–24. https://doi.org/10.1016/S0161-6420(01)00899-5.

Ciulla, T.A., Bracha, P., Pollack, J., Williams, D.F., 2018. Real-world outcomes of anti-vascular endothelial growth factor therapy in diabetic macular edema in the United States. Ophthalmol. Retina 2, 1179–1187. https://doi.org/10.1016/j.oret.2018.06.004.

Coleman, A.L., 2015. How big data informs us about cataract surgery: the LXXII Edward Jackson memorial lecture. Am. J. Ophthalmol. 160, 1091–1103.e3. https://doi.org/10.1016/j.ajo.2015.09.028.

US Congress, 2010. The Patient Protection and Affordable Care Act 2010.

Couturier, A., Giocanti-Auregan, A., Massin, P., 2020. [Treatment switch in diabetic macular edema: literature review and management algorithm]. J. Fr. Ophthalmol. 43, 710–717. https://doi.org/10.1016/j.jfio.2019.12.006.

Creuzot-Garcher, C.P., Massin, P.G., Fajnkuchen, F., Glacet-Bernard, A., Kodjikian, L., Girmens, J.-F., Delcourt, C., Guillaussau, P.-J., Ponthieux, A., 2016. Management of diabetic macular edema with visual impairment in real-life practice in France: findings from the cross-sectional BOREAL DME study. Invest. Ophthalmol. Vis. Sci. 57, 2086.

Cunha-Vaz, J., Ashton, P., Iezzi, R., Campochiaro, P., Dugel, P.U., Holz, F.G., Weber, M., Danis, R.P., Kuppermann, B.D., Bailey, C., Billman, K., Kapik, B., Kane, F., Green, K., 2014. Sustained delivery fluocinolone acetonide vitreous implants: long-term benefit in patients with chronic diabetic macular edema. Ophthalmology 121, 1892–1903. e3. https://doi.org/10.1016/j.ophtha.2014.04.019.

Curtis, L.H., Hammill, B.G., Schulman, K.A., Cousins, S.W., 2010. Risks of mortality, myocardial infarction, bleeding, and stroke associated with therapies for age-related macular degeneration. Arch. Ophthalmol. 128, 1273–1279. https://doi.org/10.1001/archophthalmol.2010.223.

Daien, V., Korobelnik, J.-F., Delcourt, C., Cougnard-Gregoire, A., Delyfer, M.N., Bron, A. M., Carrière, I., Villain, M., Daures, J.P., Lacombe, S., Mariet, A.S., Quantin, C., Creuzot-Garcher, C., 2017. French medical-administrative database for epidemiology and safety in ophthalmology (EPISAFE): the EPISAFE collaboration program in cataract surgery. ORE 58, 67–73. https://doi.org/10.1159/000456721.

Daien, V., Nguyen, V., Essex, R.W., Morlet, N., Barthelmes, Daniel, Gillies, M.C., Gillies, M., Hunt, A., Essex, R., Dayajeewa, C., Hurnor, A., Fraser-Bell, S., Younan, C., Fung, A., Guymer, R., Louis, D., Arnold, J., Chan, D., Cass, H., Harper, A., O'Day, J., Daniell, M., Field, A., Chow, L.P., Barthelmes, D., Cohn, A., Young, S., Lal, S., Ferrier, R., Barnes, R., Thompson, A., Vincent, A., Manning, L., Lake, S., Phillips, R., Perks, M., Chen, J.Y., Landers, J., Niladri, Banerjee, G., Swamy, B., Windle, P., Dunlop, A., Tang, K.C., McLean, A., Amini, A., Hunt, A., Clark, G., McAllister, I., Chen, F., Squirrel, D., Ng, C., Hinchcliffe, P., Barry, R., Ah-Chan, J., Steiner, H., Morgan, M., Thompson, C., Game, J., Murray, N., 2018. Incidence and outcomes of infectious and noninfectious endophthalmitis after intravitreal injections for age-related macular degeneration. Ophthalmology 125, 66–74. https://doi.org/10.1016/j.ophtha.2017.07.005.

Dalvin, L.A., Starr, M.R., AbouChehade, J.E., Damento, G.M., Garcia, M., Shah, S.M., Hodge, D.O., Meissner, I., Bakri, S.J., Iezzi, R., 2019. Association of intravitreal anti-vascular endothelial growth factor therapy with risk of stroke, myocardial infarction, and death in patients with exudative age-related macular degeneration. JAMA Ophthalmol. 137, 483–490. https://doi.org/10.1001/jamaophthalmol.2018.6891.

Daruich, A., Matet, M., Moulin, A., Kowalczak, L., Nicolas, M., Sellam, A., Rothschild, P.-R., Omri, S., Gélizé, E., Jonet, L., Delaunay, K., De Kozak, Y., Berdugo, M., Zhao, M., Crisanti, P., Behar-Cohen, F., 2018. Mechanisms of macular edema: beyond the surface. Prog. Retin. Eye Res. 63, 20–68. https://doi.org/10.1016/j.preteyeres.2017.10.006.

De Fauw, J., Ledsam, J.R., Romera-Paredes, B., Nikolov, S., Tomasev, N., Blackwell, S., Askham, H., Glorot, X., O'Donoghue, B., Visentin, D., van den Driessche, G., Lakshminarayanan, S., Meyer, C., Mackinder, F., Bouton, S., Ayoub, K., Chopra, R., King, D., Karthikesalingam, A., Hughes, C.O., Raine, R., Hughes, J., Sim, D.A., Egan, C., Tufail, A., Montgomery, H., Hassabis, D., Rees, G., Back, T., Khaw, P.T., Suleyman, M., Cornebise, J., Keane, P.A., Ronneberger, O., 2018. Clinically applicable deep learning for diagnosis and referral in retinal disease. Nat. Med. 24, 1342–1350. https://doi.org/10.1038/s41591-018-0107-6.

Dedov, I., Maslova, O., Suntsov, Y., Bolotskaia, L., Milenkai, T., Besmertnaia, L., 2009. Prevalence of diabetic retinopathy and cataract in adult patients with type 1 and type 2 diabetes in Russia. Rev. Diabet. Stud. 6, 124–129. https://doi.org/10.1900/RDS.2009.6.124.

Delcourt, G., Goff, M.L., Hanno, P. von, Mirshahi, A., Khawaja, A.P., Verhoeven, J.V.M., Hogg, R.E., Anastosopoulos, E., Cachulo, M.L., Höhn, R., Wolfram, C., Bron, A., Miotto, S., Carrière, I., Colijn, J.M., Buitendijk, G.H.S., Evans, J., Nitsch, D., Founti, P., Yip, J.L.Y., Pfeiffer, N., Creuzot-Garcher, C., Silva, S., Piermarocchi, S., Topouzis, F., Bertelsen, G., Foster, P.J., Fletcher, A., Klaver, C.C.W., Korobelnik, J.-F., Acar, N., Anastosopoulos, E., Azuara-Blanco, A., Berendschot, T., Bergen, A., Bertelsen, G., Binquet, C., Bird, A., Bobak, M., Boon, C., Brétillon, T., Broe, R., Bron, A., Buitendijk, G., Cachulo, M.L., Capuano, V., Carrière, I., Chakravarthy, U., Chan, M., Chang, P., Colijn, J., Cougnard-Grégoire, A., Cree, A., Creuzot-Garcher, C.,

Cumberland, P., Cunha-Vaz, J., Daien, V., Jong, E.D., Deak, G., Delcourt, C., Delyfer, M.-N., Hollander, A.den, Dietzel, M., Erke, M.G., Faria, P., Farinha, C., Fauer, S., Finger, R., Fletcher, A., Foster, P., Founti, P., Gorgels, T., Grauslund, J., Grus, F., Hammond, C., Hansen, M., Helmer, C., Hense, H.-W., Hermann, M., Hoehn, R., Hogg, R., Holz, F., Hoyng, C., Jansonius, N., Janssen, S., Kersten, E., Khawaja, A., Klaver, C., Korobelnik, J.-F., Lamparter, J., Goff, M.L., Lecheante, Y., Lehtimäki, T., Leung, I., Lotery, A., Mauschitz, M., Meester, M., Merle, B., Westrup, V.M. zu, Mídena, E., Miotto, S., Mirshahi, A., Mohan-Saïd, S., Mueller, M., Muldrew, A., Murta, J., Nickels, S., Nunes, S., Owen, C., Peto, T., Pfeiffer, N., Piermarocchi, S., Prokofyeva, E., Rahi, J., Raitakari, O., Rausch, F., Ribeiro, L., Rougier, M.-B., Rudnicka, A., Sahel, J., Salonikiou, A., Sanchez, C., Schmitz-Valckenberg, S., Schouten, J., Schuster, A., Schweitzer, C., Segato, T., Shehata, J., Silva, R., Silvestri, G., Simader, C., Souied, E., Speckauskas, M., Springelkamp, H., Tapp, R., Topouzis, F., Leeuwen, E. van, Verhoeven, V., Verzijden, T., Hanno, T.V., Vujosevic, S., Wiedemann, P., Williams, K., Wolfram, C., Yip, J., Zerbib, J., 2018. The decreasing prevalence of nonrefractive visual impairment in older Europeans: a meta-analysis of published and unpublished data. Ophthalmology 125, 1149–1159. https://doi.org/10.1016/j.ophtha.2018.02.005.

Denniston, A.K., Chakravarthy, U., Zhu, H., Lee, A.Y., Crabb, D.P., Tufail, A., Bailey, C., Akerele, T., Al-Husainy, S., Brand, C., Downey, L., Fitt, A., Khan, R., Kumar, V., Lobo, A., Mahmood, S., Mandal, K., Mckibbin, M., Menon, G., Natha, S., Ong, J.M., Tsaloumas, M.D., Varma, A., Wilkinson, E., Johnston, R.L., Egan, C.A., UK DR EMR Users Group, 2017. The UK Diabetic Retinopathy Electronic Medical Record (UK DR EMR) Users Group, Report 2: real-world data for the impact of cataract surgery on diabetic macular oedema. Br. J. Ophthalmol. 101, 1673–1678. https://doi.org/10.1136/bjophthalmol-2016-309838.

Denniston, A.K., Lee, A.Y., Lee, C.S., Crabb, D.P., Bailey, C., Lip, P.-L., Taylor, P., Pikoula, M., Cook, E., Akerele, T., Antcliff, R., Brand, C., Chakravarthy, U., Chavan, R., Dhingra, N., Downey, L., Elfetheriadis, H., Ghanchi, F., Khan, R., Kumar, V., Lobo, A., Lotery, A., Menon, G., Mukherjee, R., Palmer, H., Patra, S., Paul, B., Sim, D.A., Talks, J.S., Wilkinson, E., Tufail, A., Egan, C.A., 2019. United Kingdom Diabetic Retinopathy Electronic Medical Record (UK DR EMR) Users Group: report 4, real-world data on the impact of deprivation on the presentation of diabetic eye disease at hospital services. Br. J. Ophthalmol. 103, 837–843. https://doi.org/10.1136/bjophthalmol-2018-312568.

Dhuрува, S.S., Redberg, R.F., 2008. Variations between clinical trial participants and medicare beneficiaries in evidence used for medicare national coverage decisions. Arch. Intern. Med. 168, 136–140. https://doi.org/10.1001/archinternmed.2007.56.

Diabetic Retinopathy Clinical Research Network, 2008. A randomized trial comparing intravitreal triamcinolone acetonide and focalGRID photocoagulation for diabetic macular edema. Ophthalmology 115, 1447–145010. https://doi.org/10.1016/j.ophtha.2008.06.015.

Diabetic Retinopathy Clinical Research Network Writing Committee, 2010. Vitrectomy outcomes in eyes with diabetic macular edema and vitreomacular traction. Ophthalmology 117, 1087–1093.e3. https://doi.org/10.1016/j.ophtha.2009.10.040.

Do, D.V., 2023. Aflibercept 8 mg for diabetic macular edema: 48-week results from the phase 2/3 PHOTON trial. Invest. Ophthalmol. Vis. Sci. 64, 2814.

Do, D.V., Nguyen, Q.D., Boyer, D., Schmidt-Erfurth, U., Brown, D.M., Vitti, R., Berliner, A.J., Gao, B., Zeitz, O., Ruckert, R., Schmelter, T., Sandbrink, R., Heier, J.S., 2012. One-year outcomes of the da VINCI study of VEGF trap-eye in eyes with diabetic macular edema. Ophthalmology 119, 1658–1665. https://doi.org/10.1016/j.ophtha.2012.02.010.

Do, D.V., Nguyen, Q.D., Khwaja, A.A., Channa, R., Sepah, Y.J., Sophie, R., Hafiz, G., Campochiaro, P.A., READ-2 Study Group, 2013. Ranibizumab for edema of the macula in diabetes study: 3-year outcomes and the need for prolonged frequent treatment. JAMA Ophthalmol. 131, 139–145. https://doi.org/10.1001/2013.jamaophthalmol.91.

Do, Sepah, Y.J., Boyer, D., Callanan, D., Gallemore, R., Bennett, M., Marcus, D.M., Halperin, L., Sadiq, M.A., Rajagopalan, N., Campochiaro, P.A., Nguyen, Q.D., 2015. Month-6 primary outcomes of the READ-3 study (Ranibizumab for Edema of the Macula in Diabetes—protocol 3 with high dose). Eye 29, 1538–1544. https://doi.org/10.1038/eye.2015.142.

Dossarps, D., Bron, A.M., Koehrer, P., Aho-Glélé, L.S., Creuzot-Garcher, C., FRCR net (FReNCh Retina specialists net), 2015. Endophthalmitis after intravitreal injections: incidence, presentation, management, and visual outcome. Am. J. Ophthalmol. 160, 17–25.e1. https://doi.org/10.1016/j.ajo.2015.04.013.

Dugel, P.U., Koh, A., Ogura, Y., Jaffe, G.J., Schmidt-Erfurth, U., Brown, D.M., Gomes, A., Warburton, J., Weichselberger, A., Holz, F.G., 2020. HAWK and HARRIER: phase 3, multicenter, randomized, double-masked trials of brolucizumab for neovascular age-related macular degeneration. Ophthalmology 127, 72–84. https://doi.org/10.1016/j.ophtha.2019.04.017.

Dugel, P.U., Singh, R.P., Koh, A., Ogura, Y., Weissgerber, G., Gedif, K., Jaffe, G.J., Tadayoni, R., Schmidt-Erfurth, U., Holz, F.G., 2021. HAWK and HARRIER: ninety-six-week outcomes from the phase 3 trials of brolucizumab for neovascular age-related macular degeneration. Ophthalmology 128, 89–99. https://doi.org/10.1016/j.ophtha.2020.06.028.

Early Treatment Diabetic Retinopathy Study report number 1. Early Treatment Diabetic Retinopathy Study research group, 1985. Photocoagulation for diabetic macular edema. Arch. Ophthalmol. 103, 1796–1806.

Economic cooperation and development, 2021. OECD - toward an Integrated Health Information System in The Netherlands.

Egan, C., Zhu, H., Lee, A., Sim, D., Mitry, D., Bailey, C., Johnston, P., Chakravarthy, U., Denniston, A., Tufail, A., Khan, R., Mahmood, S., Menon, G., Akerele, T., Downey, L., McKibbin, M., Varma, A., Lobo, A., Wilkinson, E., Fitt, A., Brand, C., Tsaloumas, M., Mandal, K., Kumar, V., Natha, S., Crabb, D., UK, A.M.D., DR EMR Users Group, 2017.
The United Kingdom Diabetic Retinopathy Electronic Medical Record Users Group, Report 1: baseline characteristics and visual acuity outcomes in eyes treated with intravitreal injections of ranibizumab for diabetic macular oedema. Br J. Ophthalmol. 101, 75–80. https://doi.org/10.1136/bjophthalmol-2016-309313.

Ehlers, J.P., Wang, K., Singh, R.P., Babiuch, A.S., Schachat, A.P., Yuan, A., Reese, J.L., Stiegel, L., Srivastava, S.K., 2018. A prospective randomized comparative dosing trial of ranibizumab in bevacizumab-resistant diabetic macular edema: the REACT study. Ophthalmol. Retina 2, 217–224. https://doi.org/10.1016/j.oret.2017.07.004.

Ehlen, C., Helms, M., Böhringer, D., Agostini, H.T., Stahl, A., 2018. Association of treatment adherence with real-life VA outcomes in AMD, DME, and BRVO patients. Clin. Ophthalmol. 12, 13–20. https://doi.org/10.2147/OPTH.S151611.

Elman, M.J., Aiello, L.P., Beck, R.W., Bressler, N.M., Bressler, S.B., Edwards, A., Ferris, F.L., Friedman, S.M., Glassman, A.R., Miller, K.M., Scott, I.U., Stockdale, C.R., Sun, J.K., 2010. Randomized trial evaluating ranibizumab plus prompt or deferred laser or triamcinolone plus prompt laser for diabetic macular edema. Ophthalmology 117, 1064–1077.e35. https://doi.org/10.1016/j.ophtha.2010.02.031.

Elman, M.J., Bressler, N.M., Qin, H., Beck, R.W., Ferris, F.L., Friedman, S.M., Glassman, A.R., Scott, I.U., Stockdale, C.R., Sun, J.K., Diabetic Retinopathy Clinical Research Network. 2011. Expanded 2-year follow-up of ranibizumab plus prompt or deferred laser or triamcinolone plus prompt laser for diabetic macular edema. Ophthalmology 118, 609–614. https://doi.org/10.1016/j.ophtha.2010.12.033.

Elman, M.J., Qin, H., Aiello, L.P., Beck, R.W., Bressler, N.M., Ferris, F.L., Glassman, A.R., Maturi, R.K., Melia, M., 2012. Intravitreal ranibizumab for diabetic macular edema with prompt versus deferred laser treatment: three-year randomized trial results. Ophthalmology 119, 2312–2318. https://doi.org/10.1016/j.ophtha.2012.08.022.

Elman, M.J., Ayala, A., Bressler, N.M., Browning, D., Flaxel, C.J., Glassman, A.R., Jampol, L.M., Stone, T.W., Diabetic Retinopathy Clinical Research Network. 2015. Intravitreal Ranibizumab for diabetic macular edema with prompt versus deferred laser treatment: 5-year randomized trial results. Ophthalmology 122, 375–381. https://doi.org/10.1016/j.ophtha.2014.08.047.

Eter, N., Singh, R.P., Abreu, F., Asik, K., Basu, K., Baumal, C., Chang, A., Csaky, K.G., Haskova, Z., Lin, H., Ruiz, C.Q., Ruanvivoonsuk, P., Silverman, D., Wykoff, C.C., Willis, J.R., 2022. YOSEMITE and RHINE: phase 3 randomized clinical trials of faricamid for diabetic macular edema: study design and rationale. Ophthalmol. Sci. 2 https://doi.org/10.1016/j.xops.2021.10011.

European Medicines Agency, 2016. EMA Workshop on Identifying Opportunities for “Big Data” in Medicines Development and Regulatory Science.

European Medicines Agency, 2020. EMA Guideline on Registry-Based Studies.

Fajnkuchen, F., Delyfer, M.-N., Conrath, J., Baillif, S., Mrejen, S., Sourir, M., Bellamy, J.-P., Dupas, B., Lecleire-Collet, A., Meillon, C., Bonicel, P., Hobeika, M., Giocanti-Aurégan, A., 2020. Expectations and fears of patients with diabetes and macular edema treated by intravitreal injections. Acta Diabetol. 57, 1081–1091. https://doi.org/10.1007/s00592-020-01513-9.

Fehnel, S., DeMuro, C., McLeod, L., Coon, C., Gnanasakthy, A., 2013. US FDA patient-reported outcome guidance: great expectations and unintended consequences. Expert Rev. Pharmacoecon. Outcomes Res. 13, 441–446. https://doi.org/10.1586/14737167.2013.814957.

Fenwick, E.K., Ong, P.G., Man, R.E.K., Cheng, C.-Y., Sabanayagam, C., Wong, T.Y., Lamoureux, E.L., 2016. Association of vision impairment and major eye diseases with mobility and independence in a Chinese population. JAMA Ophthalmol. 134, 1087–1093. https://doi.org/10.1001/jamaophthalmol.2016.2394.

Fenwick, E.K., Man, R.E.K., Rees, G., Keeffe, J., Wong, T.Y., Lamoureux, E.L., 2017. Reducing respondent burden: validation of the Brief impact of vision impairment questionnaire. Qual. Life Res. 26, 479–488. https://doi.org/10.1007/s11136-016-1395-2.

Ferrara, N., Damico, L., Shams, N., Lowman, H., Kim, R., 2006. Development of ranibizumab, an anti-vascular endothelial growth factor antigen binding fragment, as therapy for neovascular age-related macular degeneration. Retina 26, 859–870. https://doi.org/10.1097/01.iae.0000242842.16426.e7.

Fileta, J.B., Scott, I.U., Flynn, H.W., 2014. Meta-analysis of infectious endophthalmitis after intravitreal injections of anti-vascular endothelial growth factor agents. Ophthalm. Surg. Lasers Imag. Retina 45, 143–149. https://doi.org/10.3928/23258160-20140306-08.

Finger, Robert P., Fenwick, E., Marella, M., Charbel Issa, P., Scholl, H.P., Holz, F.G., Lamoureux, E.L., 2011. The relative impact of vision impairment and cardiovascular disease on quality of life: the example of pseudoexanthoma elasticum. Health Qual. Life Outcome 9, 113. https://doi.org/10.1186/1477-7525-9-113.

Finger, Robert P., Fenwick, E., Marella, M., Dirani, M., Holz, F.G., Chiang, P.P.-C., Lamoureux, E.L., 2011. The impact of vision impairment on vision-specific quality of life in Germany. Invest. Ophthalmol. Vis. Sci. 52, 3613–3619. https://doi.org/10.1167/iovs.107-7127.

Finger, R.P., Guymer, R.H., Gillies, M.C., Keeffe, J.E., 2014. The impact of anti-vascular endothelial growth factor treatment on quality of life in neovascular age-related macular degeneration. Ophthalmology 121, 1246–1251. https://doi.org/10.1016/j.ophtha.2013.12.032.

Flaxel, C.J., Edwards, A.R., Aiello, L.P., Arrigg, P.G., Beck, R.W., Bressler, N.M., Bressler, S.B., Ferris, F.L.I., Gupta, S.K., Haller, J.A., Lazarus, H.S., 2010. Factors associated with visual acuity outcomes after vitrectomy for diabetic macular edema. Retina 30, 1488–1495. https://doi.org/10.1097/IAE.0b013e3181e7974f.

Flaxel, J.C., Adelman, R.A., Bailey, S.T., Fawzi, A., Lim, J.I., Vemulakonda, G.A., Ying, G., 2020. Diabetic retinopathy preferred practice pattern. Ophthalmology 127, P66–P145. https://doi.org/10.1016/j.ophtha.2019.09.025.

Fong, D.S., Segal, P.P., Myers, F., Ferris, F.L., Hubbard, L.D., Davis, M.D., 1997. Subretinal fibrosis in diabetic macular edema. ETDRS report 23. Early treatment diabetic retinopathy study research group. Arch. Ophthalmol. 115, 873–877. https://doi.org/10.1001/archopht.1997.01100160043006.

Fossum, P., Couret, C., Briend, B., Weber, M., Lagarce, L., 2018. Safety of intravitreal injection of ranibizumab in early pregnancy: a series of three cases. Eye (Lond) 32, 830–832. https://doi.org/10.1038/eye.2017.305.

Fraser-Bell, S., Lim, L.L., Campain, A., Mehta, H., Aroney, C., Bryant, J., Li, J., Quin, G.J., McAllister, I.L., Gillies, M.C., 2016. Bevacizumab or dexamethasone implants for DME: 2-year results (the BEVORDEX study). Ophthalmology 123, 1399–1401. https://doi.org/10.1016/j.ophtha.2015.12.012.

Fraser-Bell, S., Cornish, E., Gillies, M., Mehta, H., Nguyen, V., Lim, L., Sandhu, S., 2022. A Phase IV randomized clinical trial of intravitreal aflibercept monotherapy versus intravitreal aflibercept combined with targeted retinal laser to areas of peripheral retinal ischemia for diabetic macular edema in eyes with severe non-proliferative diabetic retinopathy (LADAMO). EURETINA meeting. https://euretina.org/resource/abstract_2022_a-phase-iv-randomized-clinical-trial-of-intravitreal-aflibercept-monotherapy-versus-intravitreal-aflibercept-combined-with-targeted-retinal-la-ser-to-areas-of-peripheral-retinal-ischemia/.

Gabrielle, P.-H., Massin, P., Arnould, L., Couturier, A., Bouché-Pillon, J., Maupin, E., Aho-Glele, S., Bron, A.M., Kodjikian, L., Creuzot-Garcher, C., 2020a. Development of a 1-year risk-prediction nomogram for good functional response with anti-VEGF agents in naive diabetic macular oedema. Acta Ophthalmol. 98, e975–e982. https://doi.org/10.1111/aos.14428.

Gabrielle, P.-H., Nguyen, V., Wolff, B., Essex, R., Young, S., Hunt, A., Gemmy Cheung, M., Arnold, J.J., Barthelmes, D., Creuzot-Garcher, C., Gillies, M., 2020b. Intracranial pressure changes and vascular endothelial growth factor inhibitor use in various retinal diseases: long-term outcomes in routine clinical practice: data from the fight retinal blindness! Registry. Ophthalmol. Retina 4, 861–870. https://doi.org/10.1016/j.oret.2020.06.020.

Gabrielle, P.-H., Nguyen, V., Arnould, L., Viola, Francesco, Zarranz-Ventura, Javier, Barthelmes, Daniel, Creuzot-Garcher, C., Gillies, Mark, Squirrell, D., Gilhotra, J., Brooijmans, C., Tigchelaar-Besling, O., Cohn, A., Chen, F., McGeorge, A., Welch, S., Jaross, N., Peters, P., Barry, R., McLean, T., Guillaumie, T., Miri, A., Korobelnik, J., Gabrielle, P., Weber, M., Walid, B., Tick, S., Valen, A., Wickremasinghe, S., Dayajeewa, C., Wells, M., Essex, R., Dunlop, A., Michalova, K., Ng, C., Young, S., Mimoun, G., Generic, C., Guymer, R., Carnota, P., Torres Borrego, C., Dolz Marco, R., Gallego-Pinazo, R., Pareja Esteban, J., García Layana, A., Saenz-de-Viteri, M., Uzzan, J., Ferrier, R., Ah-Chan, J., Chow, L., Steiner, H., Amini, A., Clark, M., Wittles, N., Windle, P., Vingerling, J., Clement, C., Gillies, M., Hunt, A., Beaveston, P., Cottee, L., Lee, K., Mack, H., Louw, Z., Lusthaus, J., Chen, J., Landers, J., Billing, K., Saha, N., Lake, S., Qatarneh, D., Phillips, R., Perks, M., Banon, K., Guarro, M., Londono, G., Rethati, C., Sararols, L., Suarez, J., Viola, F., Lan Oei, S., Fraser-Bell, S., Montejano Milner, R., Arruabarrena, C., Chong, E., Lal, S., Higueras, A., Ascaso, F., Boned Murillo, A., Díaz, M., Perez Rivases, G., Alforja Castilli, S., Bernal-Morales, C., Casaroli-Marano, R., Figueras-Roca, G., Izquierdo-Serra, J., Moll Udina, A., Parrado-Carrillo, A., Zarranz-Ventura, J., escobar, J., Lavid, F., Alvarez Gil, M., Catalán Muñoz, P., Tena Sempere, M., Cerri, L., Ricci, F., Broc Iturralde, L., Campos Figueroa, P., Gómez Sánchez, S., Valldeperas, X., Vilaplana, F., Carreño, E., Munoz Sanz, N., Ventura Abreu, N., Asencio Duran, M., Calvo, S., Sanchez, J., Almazan Alonso, H., Flores-Moreno, I., García Zamora, M., Ciancas, E., Gonzalez-Lopez, J., de la Fuente, M., Rodriguez Maqueda, M., Cobos, E., Lorenzo, D., Cordoves, L., Acebes, M., Aparicio-Sanchis, S., Fernández Hortalano, A., Zarallo-Gallardo, J., Azrak, C., Piñero Sánchez, A., Almuina-Varela, P., García García, L., Salinas Martínez, E., Castilla Marti, M., Campo Gesto, A., Rodriguez Núñez, M., Furness, G., Ponsioen, T., Wilson, G., Manning, L., McAllister, I., Isaacs, T., Invernizzi, A., Castelnovo, L., Michel, G., Wolff, B., Arnold, J., Cass, H., Chan, D., Tan, T., OToole, L., Tang, K., Chung, C., Beylerian, H., Daien, V., Chung, C., Banerjee, G., Morgan, M., Reddie, I., Ongkoswito, J., Verbraak, F., Schlingemann, R., Verbraak, F., piermarocchi, S., Thompson, A., Game, J., Thompson, C., Chalasani, R., Chilov, M., Fung, A., Nothing, S., Chong, R., Hunyor, A., Younan, C., Barnes, R., Sharp, D., Vincent, A., Murray, N., Ah-Moye, S., Hennings, C., Mehta, H., Monaco, P., Cheffe, G., Karia, N., Louis, D., Every, S., Lockie, P., van Hecke, M., van Lith-Verhoeven, J., Chung, C., Wong, J., Grigg, J., Hinchcliffe, P., Barthelmes, D., Diaz De Durana Santa Colama, E., Garay-Aramuru, G., Vujosevic, S., Brosa Morros, H., Daniell, M., Harper, A., Lim, L., ODay, J., Velazquez Villoria, D., Hooper, C., Klaassen-Broekema, N., Smit, R., 2022a. Incidence, risk factors, and outcomes of rhegmatogenous retinal detachment after intravitreal injections of anti-VEGF for retinal diseases: data from the fight retinal blindness! Registry. Ophthalmol. Retina 6, 1044–1053. https://doi.org/10.1016/j.oret.2022.05.008.

Gabrielle, P.-H., Nguyen, V., Bhandari, C., Mehta, H., Viola, F., Arnold, P., Fraser-Bell, S., Barthelmes, D., Creuzot-Garcher, C., Gillies, M., 2022b. Initial observation or treatment for diabetic macular oedema with good visual acuity: two-year outcomes comparison in routine clinical practice: data from the Fight Retinal Blindness! Registry. Acta Ophthalmol. 100, 285–294. https://doi.org/10.1111/aos.14672.

Gabrielle, P.-H., Nguyen, V., Creuzot-Garcher, C., Arnold, J.J., Mehta, H., Duran, M.A., Bougama, W., Carreño, E., Viola, F., Squirrell, D., Barthelmes, D., Gillies, M., 2022c. Three-year treatment outcomes of aflibercept versus ranibizumab for diabetic macular edema: data from the fight retinal blindness! Registry. Retina 42, 1085–1094. https://doi.org/10.1097/IAE.0000000000003428.

Gallardo, M., Munk, M.R., Kurmann, T., De Zanet, S., Mosinska, A., Karagoz, I.K., Zinkernagel, M.S., Wolf, S., Sznitman, R., 2021. Machine learning can predict anti-VEGF treatment demand in a treat-and-extend regimen for patients with neovascular AMD, DME, and RVO associated macular edema. Ophthalmol. Retina 5, 604–624. https://doi.org/10.1016/j.oret.2021.05.002.

Garcia, M.J., McNamara, P.M., Gordon, T., Kannel, W.B., 1974. Morbidity and mortality in diabetics in the Framingham population. Sixteen year follow up study. Diabetes 23, 105–111. https://doi.org/10.2337/diab.23.2.105.
Garweg, J.G., Stefanickova, J., Hoyng, C., Niesen, T., Schmelter, T., Leal, S., Sivaprasad, S., 2022. Dosing regimens of intravitreal aflibercept for diabetic macular edema beyond the first year: VIOLET, a prospective randomized trial. Adv. Ther. 39, 2701-2716. https://doi.org/10.1007/s12325-022-02119-z

GBD 2019 Blindness and Vision Impairment Collaborators, Vision Loss Expert Group of the Global Burden of Disease Study, 2021. Causes of blindness and vision impairment in 2020 and trends over 30 years, and prevalence of avoidable blindness in relation to VISION 2020: the Right to Sight: an analysis for the Global Burden of Disease Study. Lancet Global Health 9, e144-e160. https://doi.org/10.1016/S2214-109X(20)30489-7

Gillies, M.C., Sutter, F.K.P., Simpson, J.M., Larsson, J., Ali, H., Zhu, M., 2006. Intravitreal triamcinolone for refractory diabetic macular edema: two-year results of a double-masked, placebo-controlled, randomized clinical trial. Ophthalmology 113, 1533-1538. https://doi.org/10.1016/j.ophtha.2006.02.065.

Gillies, M.C., Simpson, J.M., Gaston, C., Hunt, G., Ali, H., Zhu, M., Sutter, F., 2009. Five-year results of a randomized trial with open-label extension of triamcinolone acetonide for refractory diabetic macular edema. Ophthalmology 116, 2182-2187. https://doi.org/10.1016/j.ophtha.2009.04.049.

Gillies, M.C., Lim, L.L., Campain, A., Quin, G.J., Salem, W., Li, J., Goodwin, S., Aroney, C., McAllister, I.L., Fraser-Bell, S., 2014a. A randomized clinical trial of intravitreal bevacizumab versus intravitreal dexamethasone for diabetic macular edema: the BEVORDEX study. Ophthalmology 121, 2473-2481. https://doi.org/10.1016/j.ophtha.2014.07.002.

Gillies, M.C., Walton, R., Liong, J., Arnold, J.J., McAllister, I., Morlet, N., Hunyor, A., Guymer, R., Keefe, J., Essex, R., Herrera-Bond, A., Glastonbury, B., Simpson, J.M., Barthelmes, D., 2014b. Efficient capture of high-quality data on outcomes of treatment for clinical diseases: the fight renal blindness! Project. Retina 34, 188-195. https://doi.org/10.1097/IAE.0b013e318296b271.

Glassman, A.R., Baker, C.W., Beaulieu, W.T., Bressler, N.M., Punjabi, O.S., Stockdale, C. R., Wykoff, C.C., Jampol, L.M., Sun, J.K., 2020a. Assessment of the DRCR retina network approach to management with initial observation for eyes with center-involved diabetic macular edema and good visual acuity: a secondary analysis of a randomized clinical trial. JAMA Ophthalmol. https://doi.org/10.1001/jamaophthalmol.2019.6035.

Glassman, A.R., Wells, J.A., Josic, K., Maguire, M.G., Antoszyk, A.N., Baker, C., Beaulieu, W.T., Elman, M.J., Jampol, L.M., Sun, J.K., 2020b. Five-year outcomes after initial aflibercept, bevacizumab, or ranibizumab treatment for diabetic macular edema (protocol T extension study). Ophthalmology 127, 1201-1210. https://doi.org/10.1016/j.ophtha.2020.03.021.

Googe, J., Brucker, A.J., Bressler, N.M., Qin, H., Aiello, L.P., Antoszyk, A., Beck, R.W., Bressler, S.B., Ferris, F.L., Glassman, A.R., Marcus, D., Stockdale, C.R., 2011. Randomized trial evaluating short-term effects of intravitreal ranibizumab or triamcinolone acetonide on macular edema after focal GRID laser for diabetic macular edema in eyes also receiving panretinal photocoagulation. Retina 31, 1009-1027. https://doi.org/10.1097/IAE.0b013e318217d739.

Grimberg, F., Asprion, P.M., Schneider, B., Miho, E., Babrak, V., Habbabeh, A., 2021. The real-world data challenges radar: a review on the challenges and risks regarding the use of real-world data. DIB 5, 148-157. https://doi.org/10.1159/000516178.

Gross, J.G., Glassman, A.R., Jampol, L.M., Inusah, S., Aiello, L.P., Antoszyk, A.N., Baker, C.W., Berger, B.B., Bressler, N.M., Browning, D., Elman, M.J., Ferris, F.L., Friedman, S.M., Marcus, D.M., Melia, M., Stockdale, C.R., Sun, J.K., Beck, R.W., 2015. Panretinal photocoagulation vs intravitreal ranibizumab for proliferative diabetic retinopathy: a randomized clinical trial. JAMA 314, 2137-2146. https://doi.org/10.1001/jama.2015.15217.

Gross, J.G., Glassman, A.R., Liu, D., Sun, J.K., Antoszyk, A.N., Baker, C.W., Bressler, N. M., Elman, M.J., Ferris, F.L., Gardner, T.W., Jampol, L.M., Martin, D.F., Melia, M., Stockdale, C.R., Beck, R.W., Diabetic Retinopathy Clinical Research Network, 2018. Five-year outcomes of panretinal photocoagulation vs intravitreal ranibizumab for proliferative diabetic retinopathy: a randomized clinical trial. JAMA Ophthalmol. 136, 1138-1148. https://doi.org/10.1001/jamaophthalmol.2018.3255.

Hautala, N., Hannula, V., Palosaari, T., Ebeling, T., Falck, A., 2014. Prevalence of diabetic retinopathy in young adults with type 1 diabetes since childhood: the Oulu cohort study of diabetic retinopathy. Acta Ophthalmol. 92, 749-752. https://doi.org/10.1011/aos.2014.12426.

Heier, J.S., Korobelnik, J.-F., Brown, D.M., Schmidt-Erfurth, U., Do, D.V., Midena, E., Boyer, D.S., Terasaki, H., Kaiser, P.K., Marcus, D.M., Nguyen, Q.D., Jaffe, G.J., Slakter, J.S., Simader, C., Soo, Y., Schmelter, T., Vitti, R., Berliner, A.J., Zeitz, O., Metzig, C., Holz, F.G., 2016. Intravitreal aflibercept for diabetic macular edema: 148-week results from the VISTA and VIVID studies. Ophthalmology 123, 2376-2385. https://doi.org/10.1016/j.ophtha.2016.07.032.

Ho, D., Imai, K., King, G., Stuart, E.A., 2011. Matcht: nonparametric preprocessing for parametric causal inference. J. Stat. Software 42, 1-28. https://doi.org/10.18637/jss.v042.i08.

Holekamp, N.M., Campbell, J., Alimony, A., Ingraham, H., Marks, S., Chandwani, H., Cole, A.L., Kiss, S., 2018. Vision outcomes following anti-vascular endothelial growth factor treatment of diabetic macular edema in clinical practice. Am. J. Ophthalmol. 191, 83-91. https://doi.org/10.1016/j.ajo.2018.04.010.

Hutton, D.W., Glassman, A.R., Stein, J.D., Bressler, N.M., Sun, J.K., 2021. Costs of managing diabetic macular edema with good visual acuity with aflibercept, laser, or observation: DRCR retina network protocol V. Am. J. Ophthalmol. 230, 297-302. https://doi.org/10.1016/j.ajo.2021.02.033.

Hwang, H., Lee, H., Kim, J.Y., Lee, S., Seo, E.J., Chae, J.B., Kim, D.Y., 2021. Systemic factors and early treatment response to intravitreal injection for diabetic macular edema: the role of renal function. Retina 41, 1275-1282. https://doi.org/10.1097/IAE.00000000000003012.

Iglicki, M., Busch, C., Zur, D., Okada, M., Mariussi, M., Chhablani, J.K., Cebeci, Z., Fraser-Bell, S., Chaikitmongkol, V., Couturier, A., Giancopoli, E., Lupidi, P., Rodríguez-Valdes, P.J., Rehak, M., Fung, A.T.-C., Goldstein, M., Loewenstein, A., 2019. Dexamethasone implant for diabetic macular edema in naïve compared with refractory eyes: the international retina group real-life 24-month multicenter study. The IRGREL-DEX Study. Retina (Philadelphia, Pa.) 39, 44-51. https://doi.org/10.1097/IAE.00000000000002196.

Introini, U., Casalino, G., Cardani, A., Scotti, F., Finardi, A., Candiani, M., Bandello, F., 2012. Intravitreal bevacizumab for a subfoveal myopic choroidal neovascularization in the first trimester of pregnancy. J. Ocul. Pharmacol. Therapeut. 28, 553-555. https://doi.org/10.1089/jop.2012.0067.

Ishibashi, T., Li, X., Koh, A., Lai, T.Y.Y., Lee, F.-L., Lee, W.-K., Ma, Z., Ohji, M., Tan, N., Cha, S.B., Shamsazar, J., Yau, C.L., REVEAL Study Group, 2015. The REVEAL study: ranibizumab monotherapy or combined with laser versus laser monotherapy in Asian patients with diabetic macular edema. Ophthalmology 122, 1402-1415. https://doi.org/10.1016/j.ophtha.2015.02.006.

Jee, D., Lee, W.K., Kang, S., 2013. Prevalence and risk factors for diabetic retinopathy: the Korea national health and nutrition examination survey 2008-2011. Invest. Ophthalmol. Vis. Sci. 54, 6827-6833. https://doi.org/10.1167/iovs.13-12654.

Jhaveri, C.D., Glassman, A.R., Ferris, F.L., Liu, D., Maguire, M.G., Allen, J.B., Baker, C. W., Browning, D., Cunningham, M.A., Friedman, S.M., Jampol, L.M., Marcus, D.M., Martin, D.F., Preston, C.M., Stockdale, C.R., Sun, J.K., 2022. Aflibercept monotherapy or bevacizumab first for diabetic macular edema. N. Engl. J. Med. https://doi.org/10.1056/NEJMoa2204225, 0, null.

Jouve, L., Akesbi, J., Nordmann, J.-P., 2015. Safety and efficacy of ranibizumab for pregnant women in idiopathic choroidal neovascularization. Acta Ophthalmol. 93, e597-e598. https://doi.org/10.1111/aoa.12611.

Kaakour, A.-H., Hua, H.-U., Rachitskaya, A., 2022. Representation of race and ethnicity in randomized clinical trials of diabetic macular edema and renal vein occlusion compared to 2010 US census data. JAMA Ophthalmol. 1-7. https://doi.org/10.1001/jamaophthalmol.2022.3929.

Kandel, H., Khadka, J., Goggin, M., Pesudovs, K., 2017. Impact of refractive error on quality of life: a qualitative study. Clin. Exp. Ophthalmol. 45, 677-688. https://doi.org/10.1111/ceo.12954.

Kandel, H., Nguyen, V., Piermarocchi, S., Ceklic, L., Teo, K., Arnalich-Montiel, F., Miotto, S., Daien, V., Gillies, M.C., Watson, S.L., 2022. Quality of life impact of eye diseases: A Save Sight Registries study. Clin. Exp. Ophthalmol. 50, 386-397. https://doi.org/10.1111/ceo.14050.

Karahalios, A., Baglietto, L., Carlin, J.B., English, D.R., Simpson, J.A., 2012. A review of the reporting and handling of missing data in cohort studies with repeated assessment of exposure measures. BMC Med. Res. Methodol. 12, 96. https://doi.org/10.1186/1471-2288-12-96.

Katkade, V.B., Sanders, K.N., Zou, K.H., 2018. Real world data: an opportunity to supplement existing evidence for the use of long-established medicines in health care decision making. J. Multidiscip. Healthc. 11, 295-304. https://doi.org/10.2147/JMDH.S160029.

Kemp, N., Newham, J., Challis, J., Jobe, A., Stock, S., 2016. The clinical use of corticosteroids in pregnancy. Hum. Reprod. 22, 240-259. https://doi.org/10.1093/humdp/dmv047.

Khadka, J., McAlinden, C., Pesudovs, K., 2013. Quality assessment of ophthalmic questionnaires: review and recommendations. Optom. Vis. Sci. 90, 720-744. https://doi.org/10.1097/OPX.00000000000000001.

Kim, S.J., Equi, R., Bressler, N.M., 2007. Analysis of macular edema after cataract surgery in patients with diabetes using optical coherence tomography. Ophthalmology 114, 881-889. https://doi.org/10.1016/j.ophtha.2006.08.053.

Kim, J.E., Glassman, A.R., Josic, K., Melia, M., Aiello, L.P., Baker, C., Eells, J.T., Jampol, L.M., Kern, T.S., Marcus, D., Salehi-Had, H., Shah, S.N., Martin, D.F., Stockdale, C.R., Sun, J.K., 2022. A randomized trial of photobiomodulation therapy for center-involved diabetic macular edema with good visual acuity (protocol AE). Ophthalmol. Retina 6, 298-307. https://doi.org/10.1016/j.oret.2021.10.003.

Klein, R., Klein, B.E., Moss, S.E., Davis, M.D., DeMets, D.L., 1984. The Wisconsin epidemiologic study of diabetic retinopathy. III. Prevalence and risk of diabetic retinopathy when age at diagnosis is 30 or more years. Arch. Ophthalmol. 102, 527-532.

Klein, R., Klein, B.E., Moss, S.E., Davis, M.D., DeMets, D.L., 1989. The Wisconsin Epidemiologic Study of Diabetic Retinopathy. IX. Four-year incidence and progression of diabetic retinopathy when age at diagnosis is less than 30 years. Arch. Ophthalmol. 107, 237-243. https://doi.org/10.1001/archophot.1989.01070010243030.

Klein, R., Klein, B.E., Moss, S.E., Cruickshanks, K.J., 1994. The Wisconsin Epidemiologic Study of diabetic retinopathy. XIV. Ten-year incidence and progression of diabetic retinopathy. Arch. Ophthalmol. 112, 1217-1228. https://doi.org/10.1001/archophot.1994.01090210105023.

Klein, B.E.K., Klein, R., Moss, S.E., 1995. Incidence of cataract surgery in the Wisconsin epidemiologic study of diabetic retinopathy. Am. J. Ophthalmol. 119, 295-300. https://doi.org/10.1016/S0002-9394(14)71170-5.

Klein, R., Klein, B.E., Moss, S.E., Cruickshanks, K.J., 1998. The Wisconsin Epidemiologic Study of Diabetic Retinopathy: XVII. The 14-year incidence and progression of diabetic retinopathy and associated risk factors in type 1 diabetes. Ophthalmology 105, 1801-1815. https://doi.org/10.1016/S0161-6420(98)91020-X.

Klein, B.E.K., Knudson, M.D., Tsai, M.Y., Klein, R., 2009. The relation of markers of inflammation and endothelial dysfunction to the prevalence and progression of diabetic retinopathy: Wisconsin epidemiologic study of diabetic retinopathy. Arch. Ophthalmol. 127, 1175-1182. https://doi.org/10.1001/archophthalmol.2009.172.

Kodjikian, L., Lecleire-Collet, A., Dot, C., Le Lez, M.-L., Baillif, S., Erginay, A., Souied, E., Fourmaux, E., Gain, P., Ponthieux, A., 2021. ETOILE: real-world evidence of 24
Months of ranibizumab 0.5 mg in patients with visual impairment due to diabetic macular edema. Clin. Ophthalmol. 15, 2307-2315. https://doi.org/10.2147/OPTH.S313081.

Korobelnik, J.-F., Do, D.V., Schmidt-Erfurth, U., Boyer, D.S., Holz, F.G., Heier, J.S., Midena, E., Kaiser, P.K., Terasaki, H., Marcus, D.M., Nguyen, Q.D., Jaffe, G.J., Slakter, J.S., Simader, C., Soo, Y., Schmelter, T., Yancopoulos, G.D., Stahl, N., Vitti, R., Berliner, A.J., Zeitz, O., Metzig, C., Brown, D.M., 2014. Intravitreal aflibercept for diabetic macular edema. Ophthalmology 121, 2247-2254. https://doi.org/10.1016/j.ophtha.2014.05.006.

Korobelnik, J.-F., Daien, V., Faure, C., Tadayoni, R., Giocanti-Auregan, A., Dot, C., Kodjikian, L., Massin, P., 2020. Real-world outcomes following 12 months of intravitreal aflibercept monotherapy in patients with diabetic macular edema in France: results from the APOLLON study. Graefes Arch. Clin. Exp. Ophthalmol. 258, 521-528. https://doi.org/10.1007/s00417-019-04592-9.

Kung, K., Chow, K.M., Hui, E.M.-T., Leung, M., Leung, S.Y., Szeto, C.C., Lam, A., Li, P.K.-T., 2014. Prevalence of complications among Chinese diabetic patients in urban primary care clinics: a cross-sectional study. BMC Fam. Pract. 15, 8. https://doi.org/10.1186/1471-2296-15-8.

Lam, D.S.C., Chan, K.C.M., Mohamed, S., Lai, T.Y.Y., Lee, V.Y.W., Lai, W.W., Fan, D.S.P., Chan, W.-M., 2005. Phacoemulsification with intravitreal triamcinolone in patients with cataract and coexisting diabetic macular oedema: a 6-month prospective pilot study. Eye 19, 885-890. https://doi.org/10.1038/sj眼.6701686.

Lamoureux, E.L., Pallant, J.F., Pesudovs, K., Hassell, J.B., Keeffe, J.E., 2006. The impact of vision impairment questionnaire: an evaluation of its measurement properties using Rasch analysis. Invest. Ophthalmol. Vis. Sci. 47, 4732-4741. https://doi.org/10.1167/iovs.06-0220.

Lamoureux, E.L., Chong, E.W., Thumboob, J., Wei, H.L., Wang, J.J., Saw, S.-M., Aung, T., Wong, T.Y., 2008. Vision impairment, ocular conditions, and vision-specific function: the Singapore Malay eye study. Ophthalmology 115, 1973-1981. https://doi.org/10.1016/j.ophtha.2008.05.005.

Lamoureux, E., Gadgil, S., Pesudovs, K., Keeffe, J., Fenwick, E., Dirani, M., Salonen, S., Rees, G., 2010. The relationship between visual function, duration and main causes of vision loss and falls in older people with low vision. Graefes Arch. Clin. Exp. Ophthalmol. 248, 527-533. https://doi.org/10.1016/j.ophtha.2013.02.019.

Lang, G.E., Berta, A., Eldem, B.M., Simader, C., Sharp, D., Holz, F.G., Sutter, F., Gerstner, O., Mitchell, P., RESTORE Extension Study Group, 2013. Two-year safety and efficacy of ranibizumab 0.5 mg in diabetic macular edema: interim analysis of the RESTORE extension study. Ophthalmology 120, 2004-2012. https://doi.org/10.1016/j.ophtha.2013.02.019.

Lavertu, A., Vora, B., Giacomini, K.M., Altman, R., Rensi, S., 2021. A new era in pharmacovigilance: toward real-world data and digital monitoring. Clin. Pharmacol. Therapeut. 109, 1197-1202. https://doi.org/10.1002/cpt.2172.

Leasher, J.L., Bourne, R.R.A., Flaxman, S.R., Jonas, J.B., Keeffe, J., Naidoo, K., Pesudovs, K., Price, H., White, R.A., Wong, T.Y., Resnikoff, S., Taylor, H.R., on behalf of the Vision Loss Expert Group of the Global Burden of Disease Study, 2016. Global estimates on the number of people blind or visually impaired by diabetic retinopathy: a meta-analysis from 1990 to 2010. Diabetes Care 39, 1643-1649. https://doi.org/10.2337/dc15-2171.

Lehrer, S., Arnould, L., Bourriedjem, A., Busch, C., Rehak, M., Massin, P., Barbosa-Breda, J., Lupidi, M., Mariotti, C., Hamza, M., Grise-Dulac, A., Gabrielle, P.-H., Baillif, S., Creuzot-Garcher, C., 2022. Intraocular pressure changes after intravitreal fluocinolone acetonide implant: results from four European countries. Ophthalmol. Ther. 11, 1217-1229. https://doi.org/10.1007/s40123-022-00504-z.

Lee, E.T., Lee, V.S., Kingsley, R.M., Lu, M., Russell, D., Asal, N.R., Wilkinson, C.P., Bradford, R.H., 1992. Diabetic retinopathy in Oklahoma Indians with NIDDM. Incidence and risk factors. Diabetes Care 15, 1620-1627. https://doi.org/10.2337/diacare.15.11.1620.

Lee, C.S., Lee, A.Y., Baughman, D., Sim, D., Akelere, T., Brand, C., Crabb, D.P., Denniston, A.K., Downey, L., Fitt, A., Khan, R., Mahmood, Sajjad, Mandal, K., Mckibbin, Martin, Menon, D., Lobo, A., Kumar, B.V., Natha, S., Varma, A., Wilkinson, E., Mitry, D., Bailey, C., Chakravarthy, U., Tufail, A., Egan, C., Chakravarthy, U., Ghanchi, F., Khan, R., Ong, J.M., Mahmood, Sajjad, Menon, G., Mohamed, Q., Al-Husainy, S., Akelere, T., Downey, L., Mckibbin, Marin, Dhingra, N., Wilkinson, E., Dhingra, S., Antcliff, R., Denniston, A.K., Bailey, C., Mandal, K., Kumar, V., Natha, S., 2017. The United Kingdom diabetic retinopathy electronic medical record users group: report 3: baseline retinopathy and clinical features predict progression of diabetic retinopathy. Am. J. Ophthalmol. 180, 64-71. https://doi.org/10.1016/j.ajo.2017.05.020.

Levine, S.R., Sapieha, P., Dutta, S., Sun, J.K., Gardner, T.W., 2022. It is time for a moonshot to find “Cures” for diabetic retinal disease. Prog. Retin. Eye Res. 90, 101051 https://doi.org/10.1016/j.pretyeeres.2022.101051.

Liu, Lei, Wu, X., Liu, Limin, Geng, J., Yuan, Z., Shan, Z., Chen, L., 2012. Prevalence of diabetic retinopathy in mainland China: a meta-analysis. PLoS One 7, e45264. https://doi.org/10.1371/journal.pone.0045264.

Lois, N., Campbell, C., Waugh, N., Azuara-Blanco, A., Maredza, M., Mistry, H., McAuley, D., Acharya, N., Aslam, T.M., Bailey, C., Chong, V., Downey, L., Eleftheriadis, H., Fatum, S., George, S., Ghanchi, F., Groppe, M., Hamilton, R., Menon, D., Saad, A., Sivaprasad, S., Shiew, M., Steel, D.H., Talks, J.S., Doherty, P., McDowell, C., Clarke, M., 2022. DIAMAC Macular Oedema And Diode Subthreshold micropulse laser (DIAMONDS): a randomized double-masked non-inferiority clinical trial. Ophthalmology. 101 (1016/j.ophtha.2022.08.012, 0.

Lu, A.J., Chen, A.J., Hwang, V., Law, P.Y., Stewart, J.M., Chao, D.L., 2019. Analysis of patient-reported barriers to diabetic retinopathy follow-up. Ophthalm. Surg. Lasers Imag. Retina 50, 99-105. https://doi.org/10.3928/23258160-20190129-06.

Lukic, M., Williams, G., Shalchi, Z., Sim, D., Patel, P.J., Keane, P.A., Hykin, P.G., Sivaprasad, S., Menon, D., Bruynseels, A., Hamilton, R.D., Rajendram, R., 2019.

Intravitreal aflibercept for diabetic macular oedema: moorfields' real-world 12-month visual acuity and anatomical outcomes. Eur. J. Ophthalmol. 1120672119833270 https://doi.org/10.1177/120672119833270.

Macugen Diabetic Retinopathy Study Group, 2005. A phase II randomized double-masked trial of pegaptanib, an anti-vascular endothelial growth factor aptamer, for diabetic macular edema. Ophthalmology 112, 1747-1757. https://doi.org/10.1016/j.ophtha.2005.06.007.

Malclès, A., Janin-Manificat, H., Yhuel, Y., Russo, A., Agard, E., El Chehab, H., Ract Madoux, G., Masse, H., Burillon, C., Dot, C., 2013. Migration en chambre antérieure de l'implant intravitranéen de dexamethasone OzurDEX® chez le pseudophaco : à propos de trois cas. J. Fr. Ophthalmol. 36, 362-367. https://doi.org/10.1016/j.jfo.2012.11.003.

Malclès, A., Dot, C., Voirin, N., Agard, É., Vié, A.-L., Bellocq, D., Denis, P., Kodjikian, L., 2017a. Real-life study in diabetic macular edema treated with dexamethasone implant: the reldex study. Retina 37, 753-760. https://doi.org/10.1097/IAE.0000000000001234.

Malclès, A., Dot, C., Voirin, N., Vié, A.-L., Agard, É., Bellocq, D., Denis, P., Kodjikian, L., 2017b. Safety of intravitreal dexamethasone implant (OZURDEX): the SAFODEX study. Incidence and risk factors of ocular hypertension. Retina 37, 1352-1359. https://doi.org/10.1097/IAE.0000000000001369.

Malhotra, N.A., Greenlee, T.E., Iyer, A.I., Conti, T.F., Chen, A.X., Singh, R.P., 2021. Racial, ethnic, and insurance-based disparities upon initiation of anti-vascular endothelial growth factor therapy for diabetic macular edema in the US. Ophthalmology 128, 1438-1447. https://doi.org/10.1016/j.ophtha.2021.03.010.

Mammo, D.A., Ringeisen, A.L., Parke, D.W., 2020. Frequency of rhegmatogenous retinal detachment after intravitreal therapy in neovascular age-related macular degeneration. Oph. Retina 4, 973-978. https://doi.org/10.1016/j.oret.2020.03.028.

Martens, E.P., Pestman, W.R., de Boer, A., Belitser, S.V., Klungel, O.H., 2006. Instrumental variables: application and limitations. Epidemiology 17, 260-267. https://doi.org/10.1097/01.ede.0000215160.88317.cb.

Martín-Merino, E., Fortuny, J., Rivero-Ferrer, E., García-Rodríguez, L.A., 2014. Incidence of retinal complications in a cohort of newly diagnosed diabetic patients. PLoS One 9, e100283. https://doi.org/10.1371/journal.pone.0100283.

Massin, P., Baillif, S., Creuzot, C., Fajnkuchen, F., Kodjikian, L., 2015. Treatment of Diabetic Macular Edema 11.

Massin, P., Creuzot-Garcher, C., Kodjikian, L., Girmens, J.-F., Delcourt, C., Fajnkuchen, F., Glacet-Bernard, A., Guillausseau, P.-J., Ponthieux, A., Blin, P., Grelaud, A., 2019. Real-world outcomes with ranibizumab 0.5 mg in patients with visual impairment due to diabetic macular edema: 12-month results from the 36-month BOREAL-DME study. Ophthalmic Res. 62, 101-110. https://doi.org/10.1159/000497406.

Massof, R.W., 2002. The measurement of vision disability. Optom. Vis. Sci. 79, 516-552.

Maturi, R.K., Glassman, A.R., Liu, D., Beck, R.W., Bhavsar, A.R., Bressler, N.M., Jampol, L.M., Melia, M., Punjabi, O.S., Salehi-Had, H., Sun, J.K., 2018. Effect of adding dexamethasone to continued ranibizumab treatment in patients with persistent diabetic macular edema. JAMA Ophthalmol. 136, 29-38. https://doi.org/10.1001/jamaophthalmol.2017.4914.

Mauschitz, M.M., Bonnemaijer, P.W.M., Diers, K., Rauscher, F.G., Elze, T., Engel, C., Loeffler, M., Colijn, J.M., Ikram, M.A., Vingerling, J.R., Williams, K.M., Hammond, C.J., Creuzot-Garcher, C., Bron, A.M., Silva, R., Nunes, S., Delcourt, C., Cougnard-Grégoire, A., Holz, F.G., Klaver, C.C.W., Breteler, M.M.B., Finger, R.P., European Eye Epidemiology (E3) Consortium, 2018. Systematic and ocular determinants of peripapillary retinal nerve fiber layer thickness measurements in the European eye epidemiology (E3) population. Ophthalmology 125, 1526-1536. https://doi.org/10.1016/j.ophtha.2018.03.026.

Mehta, H., Fraser-Bell, S., Yeung, A., Campain, A., Lim, L.L., Quin, G.J., McAllister, L.L., Keane, P.A., Gillies, M.C., 2016. Efficacy of dexamethasone versus bevacizumab on regression of hard exudates in diabetic maculopathy: data from the BEVORDEX randomised clinical trial. Br. J. Ophthalmol. 100, 1000-1004. https://doi.org/10.1136/bjophthalmol-2015-307799.

Mehta, H., Hennings, C., Gillies, M.C., Nguyen, V., Campain, A., Fraser-Bell, S., 2018a. Anti-vascular endothelial growth factor combined with intravitreal steroids for diabetic macular oedema. Cochrane Database Syst. Rev. https://doi.org/10.1002/14651858.CD011599.pub2, CD011599.

Mehta, H., Tufail, A., Daien, V., Lee, A.Y., Nguyen, V., Ozturk, M., Barthelmes, D., Gillies, M.C., 2018b. Real-world outcomes in patients with neovascular age-related macular degeneration treated with intravitreal vascular endothelial growth factor inhibitors. Prog. Retin. Eye Res. 65, 127-146. https://doi.org/10.1016/j.pretyeeres.2017.12.002.

Mehta, H., Nguyen, V., Barthelmes, D., Pershing, S., Chi, G.C., Dopart, P., Gillies, M.C., 2022. Outcomes of over 40,000 eyes treated for diabetic macula edema in routine clinical practice: a systematic review and meta-analysis. Adv. Ther. https://doi.org/10.1007/s12325-022-02326-8.

Michaelides, M., Fraser-Bell, S., Hamilton, R., Kaines, A., Egan, C., Bunce, C., Peto, T., Hykin, P., 2010a. Macular perfusion determined by fundus fluorescein angiography at the 4-month time point in a prospective randomized trial of intravitreal bevacizumab or laser therapy in the management of diabetic macular edema (Bolt Study): report 1. Retina 30, 781-786. https://doi.org/10.1097/iae.0b013e3181d2f145.

Michaelides, M., Kaines, A., Hamilton, R.D., Fraser-Bell, S., Rajendram, R., Quhill, F., Boos, C.J., Xing, W., Egan, C., Peto, T., Bunce, C., Leslie, R.D., Hykin, P.G., 2010b. A prospective randomized trial of intravitreal bevacizumab or laser therapy in the management of diabetic macular edema (BOLT study) 12-month data: report 2. Ophthalmology 117, 1078-1086.e2. https://doi.org/10.1016/j.ophtha.2010.03.045.
Mitchell, P., 2007. The National Health and Medical Research Council Australian Guidelines for the Management of Diabetic Retinopathy.

Mitchell, P., Bandello, F., Schmidt-Erfurth, U., Lang, G.E., Massin, P., Schlingemann, R. O., Sutter, F., Simader, C., Burian, G., Gerstner, O., Weichselberger, A., RESTORE study group, 2011. The RESTORE study: ranibizumab monotherapy combined with laser versus laser monotherapy for diabetic macular edema. Ophthalmology 118, 615–625. https://doi.org/10.1016/j.ophtha.2011.01.031.

Mitchell, P., Sheidow, T.G., Farah, M.E., Mahmood, S., Minnella, A.M., Eter, N., Eldem, B., Al-Dhibi, H., Macfadden, W., Parikh, S., Dunger-Baldauf, C., Mahgoub, M. M., Schmidt-Erfurth, U., Investigators, on behalf of the L. study, 2020. Effectiveness and safety of ranibizumab 0.5 mg in treatment-naïve patients with diabetic macular edema: results from the real-world global LUMINOUS study. PLoS One 15, e0233595. https://doi.org/10.1371/journal.pone.0233595.

Molenberghs, G., Thijs, H., Jansen, I., Beunckens, C., Kenward, M.G., Mallinckrodt, C., Carroll, R.J., 2004. Analyzing incomplete longitudinal clinical trial data. Biostatistics 5, 445–464. https://doi.org/10.1093/biostatistics/5.3.445.

Monés, J., Srivastava, S.K., Jaffe, G.J., Tadayoni, R., Albini, T.A., Kaiser, P.K., Holz, F.G., Korobelnik, J.-F., Kim, I.K., Puente, C., Murray, T.G., Heier, J.S., 2021. Risk of inflammation, retinal vasculitis, and retinal occlusion-related events with brolucizumab: post hoc review of HAWK and HARRIER. Ophthalmology 128, 1050–1059. https://doi.org/10.1016/j.ophtha.2020.11.011.

Moshfeghi, A.A., Shapiro, H., Lemmon, L.A., Gune, S., 2018. Impact of cataract surgery during treatment with ranibizumab in patients with diabetic macular edema. Ophthalmol. Retina 2, 86–90. https://doi.org/10.1016/j.oret.2017.05.003.

Naderan, M., Sabzevina, R., Rezaii, K., Banafshehafshan, A., Hantoushzadeh, S., 2021. Intravitreal anti-vascular endothelial growth factor medications during pregnancy: current perspective. Int. Ophthalmol. 41, 743–751. https://doi.org/10.1007/s10792-020-01610-2.

Nguyen, Q.D., Shah, S.M., Heier, J.S., Do, D.V., Lim, J., Boyer, D., Abraham, P., Campochiaro, P.A., READ-2 Study Group, 2009. Primary end point (six months) results of the ranibizumab for edema of the mAcula in diabetes (READ-2) study. Ophthalmology 116, 2175–2181.e1. https://doi.org/10.1016/j.ophtha.2009.04.023.

Nguyen, Q.D., Shah, S.M., Khwaja, A.A., Channa, R., Hatzef, E., Do, D.V., Boyer, D., Heier, J.S., Abraham, P., Thach, A.B., Lit, E.S., Foster, B.F., Kruger, E., Dugel, P., Chang, T., Das, A., Ciulla, T.A., Pollack, J.S., Lim, J.I., Eliott, D., Eliot, D., Campochiaro, P.A., READ-2 Study Group, 2010. Two-year outcomes of the ranibizumab for edema of the mAcula in diabetes (READ-2) study. Ophthalmology 117, 2146–2151. https://doi.org/10.1016/j.ophtha.2010.08.016.

Nguyen, Q.D., Brown, D.M., Marcus, D.M., Boyer, D.S., Patel, S., Feiner, L., Gibson, A., Sy, J., Rundle, A.C., Hopkins, J.J., Rubio, R.G., Ehrlich, J.S., RISE and RIDE Research Group, 2012. Ranibizumab for diabetic macular edema: results from 2 phase III randomized trials: RISE and RIDE. Ophthalmology 119, 789–801. https://doi.org/10.1016/j.ophtha.2011.12.039.

Nguyen, Q.D., Das, A., Do, D.V., Dugel, P.U., Gomes, A., Holz, F.G., Koh, A., Pan, C.K., Sepah, Y.J., Patel, N., MacLeod, H., Maurer, P., 2020. Brolucizumab: evolution through preclinical and clinical studies and the implications for the management of neovascular age-related macular degeneration. Ophthalmology 127, 963–976. https://doi.org/10.1016/j.ophtha.2019.12.031.

Nguyen, V., Leung, K.F.C., Nguyen, C.L., Squirreld, R., Essex, R., Arnold, J., Young, S., Barthelmes, D., Gillies, M., Fight Retinal Blindness! Study Group, 2020. Assessing the accuracy of a large observational registry of neovascular age-related macular degeneration. Retina 40, 866–872. https://doi.org/10.1097/IAE.00000000000002485.

Nguyen, V., Barthelmes, D., Gillies, M.C., 2021. Neovascular age-related macular degeneration: a review of findings from the real-world Fight Retinal Blindness! registry. Clin. Exp. Ophthalmol. 49, 652–663. https://doi.org/10.1111/ceo.13949.

Ogurtsova, K., da Rocha Fernandes, J.D., Huang, Y., Linnenkamp, U., Guariguata, L., Cho, N.H., Cavan, D., Shaw, J.E., Makaroff, L.E., 2017. IDF Diabetes Atlas: Global Estimates for the Prevalence of Diabetes for 2015 and 2040. Diabetes Research and Clinical Practice, vol. 128. https://doi.org/10.1016/j.diabetes.2017.03.024.

Okada, M., Mitchell, P., Finger, R.P., Eldem, B., Talks, S.J., Hirst, C., Paladini, L., Barratt, J., Wong, T.Y., Loewenstein, A., 2021. Nonadherence or nonpersistence to intravitreal injection therapy for neovascular age-related macular degeneration: a mixed-methods systematic review. Ophthalmology 128, 234–247. https://doi.org/10.1016/j.ophtha.2020.07.060.

Otsuka, H., Kawano, H., Sonoda, S., Nakamura, M., Sakamoto, T., 2013. Particle-induced endophthalmitis: possible mechanisms of sterile endophthalmitis after intravitreal triamcinolone. Invest. Ophthalmol. Vis. Sci. 54, 1758–1766. https://doi.org/10.1167/iovs.12-11247.

Owen, J.P., Blazes, M., Lacy, M., Yanagihara, R.T., Van Gelder, R.N., Lee, A.Y., Lee, C.S., 2021. Refractive outcomes after immediate sequential vs delayed sequential bilateral cataract surgery. JAMA Ophthalmol. 139, 876–885. https://doi.org/10.1001/jamaophthalmol.2021.2032.

Oxford Centre for Evidence-Based Medicine: Levels of Evidence, 2009. Centre for Evidence-Based Medicine (CEBM). March. University of Oxford [WWW Document], n.d. URL. https://www.cebm.ox.ac.uk/resources/levels-of-evidence/oxford-centre-for-evidence-based-medicine-levels-of-evidence-march-2009. (Accessed 13 October 2022).

Ozkaya, A., Alagoz, C., Alagoz, N., Gunes, H., Yilmaz, H., Perente, I., Yazici, A.T., Tapaskili, M., 2016. Dexamethasone implant in pseudophakic and nonglaucomatous subgroup of diabetic macular edema patients: a real life experience. Eur. J. Ophthalmol. 26, 351–355. https://doi.org/10.5301/ejo.5000725.

Papadopoulos, N., Martin, J., Ruan, Q., Rafique, A., Rosconi, M.P., Shi, E., Pyles, E.A., Yancopoulos, G.D., Stahl, N., Wiegand, S.J., 2012. Binding and neutralization of vascular endothelial growth factor (VEGF) and related ligands by EGF Trap, ranibizumab and bevacizumab. Angiogenesis 15, 171–185. https://doi.org/10.1007/s10456-011-9249-6.

Parke, D.W., Rich, W.L., Sommer, A., Lum, F., 2017. The American Academy of ophthalmology's IRIS® registry (intelligent research in sight clinical data): a look back and a look to the future. Ophthalmology 124, 1572–1574. https://doi.org/10.1016/j.ophtha.2017.08.035.

Patel, P.J., Foster, P.J., Grossi, C.M., Keane, P.A., Ko, F., Lottery, A., Peto, T., Reisman, C. A., Strouthidis, N.G., Yang, Q., 2016. Spectral-domain optical coherence tomography imaging in 67 321 adults: associations with macular thickness in the UK biobank study. Ophthalmology 123, 829–840. https://doi.org/10.1016/j.ophtha.2015.11.009.

Patrao, N.V., Antao, S., Egan, C., Omar, A., Hamilton, R., Hykin, P.G., Sivaprasad, S., Rajendram, R., Moorfields Diabetic Macular Edema Study Group, 2016. Real-world outcomes of ranibizumab treatment for diabetic macular edema in a United Kingdom national health service setting. Am. J. Ophthalmol. 172, 51–57. https://doi.org/10.1016/j.ajo.2016.09.002.

Payne, J.F., Wykoff, C.C., Clark, W.L., Bruce, B.B., Boyer, D.S., Brown, D.M., 2017. Randomized trial of treat and extend ranibizumab with and without navigated laser for diabetic macular edema: TREX-DME 1 Year outcomes. Ophthalmology 124, 74–81. https://doi.org/10.1016/j.ophtha.2016.09.021.

Payne, J.F., Wykoff, C.C., Clark, W.L., Bruce, B.B., Boyer, D.S., Brown, D.M., Payne, J.F., Clark, W.L., Wells, J.A., Johnson, D.L., Wykoff, C.C., Brown, D.M., Benz, M., Chen, E., Fish, R.H., Kim, R.Y., Major, J.C., O'Malley, R.E., Schefler, A.C., Shah, A.R., Wong, T.P., Boyer, D.S., Novack, R.L., Chu, T.G., Rahhal, F., Tabandeh, H., Roe, R. H., Dayani, P.N., Liao, D., Walsh, A., Esmaili, D.D., 2019. Randomized trial of treat and extend ranibizumab with and without navigated laser versus monthly dosing for diabetic macular edema: TREX-DME 2-year outcomes. Am. J. Ophthalmol. 202, 91–99. https://doi.org/10.1016/j.ajo.2019.02.005.

Payne, J.F., Wykoff, C.C., Clark, W.L., Bruce, B.B., Boyer, D.S., Brown, D.M., 2021. Long-term outcomes of treat-and-extend ranibizumab with and without navigated laser for diabetic macular oedema: TREX-DME 3-year results. Br. J. Ophthalmol. 105, 253–257. https://doi.org/10.1136/bjophthalmol-2020-31676.

Pearson, P.A., Comstock, T.L., Ip, M., Callanan, D., Morse, L.S., Ashton, P., Levy, B., Mann, E.S., Eliott, D., 2011. Fluocinolone acetonide intravitreal implant for diabetic macular edema: a 3-year multicenter, randomized, controlled clinical trial. Ophthalmology 118, 1580–1587. https://doi.org/10.1016/j.ophtha.2011.02.048.

Pedro, R.-A., Ramon, S.-A., Marc, B.-B., Juan, F.-B., Isabel, M.-M., 2010. Prevalence and relationship between diabetic retinopathy and nephropathy, and its risk factors in the north-East of Spain, a population-based study. Ophthalmic Epidemiol. 17, 251–265. https://doi.org/10.3109/09286586.2010.498661.

Peracha, Z.H., Rosenfeld, P.J., 2016. Anti-vascular endothelial growth factor therapy in pregnancy: what we know, what we don't know, and what we don't know we don't know. Retina 36, 1413–1417. https://doi.org/10.1097/IAE.00000000000001200.

Pershing, S., Lum, F., 2022. The American Academy of Ophthalmology IRIS Registry (Intelligent Research in Sight): current and future state of big data analytics. Curr. Opin. Ophthalmol. 33, 394–398. https://doi.org/10.1097/ICU.00000000000000869.

Pesudovs, K., 2006. Patient-centred measurement in the UK: a paradigm shift. BMC Ophthalmol. 6, 25. https://doi.org/10.1186/1471-2415-6-25.

Peto, T., Akerele, T., Sagkriotis, A., Zappacosta, S., Clemens, U., Chakravarthy, U., 2022. Treatment patterns and persistence rates with anti-vascular endothelial growth factor treatment for diabetic macular oedema in the UK: a real-world study. Diabet. Med. 39, e14746 https://doi.org/10.1111/dme.14746.

Petrou, P., Georgalas, I., Giavaras, G., Anastasiou, E., Ntana, Z., Petrou, C., 2010. Early loss of pregnancy after intravitreal bevacizumab injection. Acta Ophthalmol. 88 https://doi.org/10.1111/j.1755-3768.2009.01572.x e136–e136.

Polizzi, S., Mahajan, V.B., 2015. Intravitreal anti-VEGF injections in pregnancy: case series and review of literature. J. Ocul. Pharmacol. Therapeut. 31, 605–610. https://doi.org/10.1089/jop.2015.0056.

Polizzi, S., Ferrara, R., Restaino, S., Rinaldi, S., Tognetto, D., 2015. Inadvertent use of bevacizumab in pregnant women with diabetes mellitus type 1. J. Basic Clin. Physiol. Pharmacol. 26, 161–163. https://doi.org/10.1515/jbcpp-2014-0058.

Prünte, C., Fajnkuchen, F., Mahmood, S., Ricci, F., Hatz, K., Studnička, J., Bezlyak, V., Parikh, S., Stubbings, W.J., Wenzel, A., Figueira, J., RETAIN Study Group, 2016. Ranibizumab 0.5 mg treat-and-extend regimen for diabetic macular oedema: the RETAIN study. Br. J. Ophthalmol. 100, 787–795. https://doi.org/10.1136/bjophthalmol-2015-307249.

Rajendram, R., Fraser-Bell, S., Kaines, A., Michaelides, M., Hamilton, R.D., Esposti, S.D., Peto, T., Egan, C., Bunce, C., Leslie, R.D., Hykin, P.G., 2012. A 2-year prospective controlled trial of intravitreal bevacizumab or laser therapy (BOLT) in the management of diabetic macular edema: 24-month data: report 3. Arch. Ophthalmol. 130, 972–979. https://doi.org/10.1001/archophthalmol.2012.393.

Rajesh, B., Zarranz-Ventura, J., Fung, A.T., Busch, S., Sahoo, N.K., Rodriguez-Valdes, P. J., Sarao, V., Mishra, S.K., Saatci, A.O., Udaondo Mirete, P., Querques, S., Farah, M. E., Lanzetta, P., Arevalo, J.F., Kodjikian, L., Chhablani, J., for International Ozzurdx Study Group, 2020. Safety of 6000 intravitreal dexamethasone implants. Br. J. Ophthalmol. 104, 39–46. https://doi.org/10.1136/bjophthalmol-2019-313991.

Raman, R., Vasconcelos, J.C., Rajalakshmi, R., Prevost, A.T., Ramasamy, K., Mohan, V., Mohan, D., Rani, P.K., Conroy, D., Das, T., Sivaprasad, S., Bhende, P., Surya, J., Gopal, L., Ramakrishnan, R., Roy, R., Das, S., Manayath, G., Pooleeswaran, V.T., Anantharaman, G., Gopalakrishnan, M., Natarajan, S., Krishnan, R., Mani, S.L., Agarwal, M., Behera, U., Bhattacharjee, H., Barman, S., Sen, A., Saxena, M., Sil, A. K., Chakrabarty, S., Cherian, T., Jitesh, R., Naigaonkar, R., Desai, A., Kulkarni, S., 2022. Prevalence of diabetic retinopathy in India stratified by known and undiagnosed diabetes, urban–rural locations, and socioeconomic indices: results from the SMART India population-based cross-sectional screening study. Lancet Global Health 10, e1764–e1773. https://doi.org/10.1016/S2214-109X(22)00411-9.
Rao, P., Lum, F., Wood, K., Salman, C., Burugapalli, B., Hall, R., Singh, S., Parke, D.W., Williams, G.A., 2018. Real-world vision in age-related macular degeneration patients treated with single anti-VEGF drug type for 1 Year in the IRIS registry. Ophthalmology 125, 522–528. https://doi.org/10.1016/j.ophtha.2017.10.010.

Rauen, P.I., Ribeiro, J.A., Almeida, F.P., Scott, I.U., Messias, A., Jorge, R., 2012. Intravitreal injection of ranibizumab during cataract surgery in patients with diabetic macular edema. Retina 32, 1799–1803.

Rayess, N., Rahimy, E., Shah, C.P., Wolfe, J.D., Chen, E., DeCroos, F.C., Storey, P., Garg, S.J., Hsu, J., 2016. Incidence and clinical features of post-injection endophthalmitis according to diagnosis. Br. J. Ophthalmol. 100, 1058–1061. https://doi.org/10.1136/bjophthalmol-2015-307707.

Régner, S., Malcolm, W., Allen, F., Wright, J., Bezlyak, V., 2014. Efficacy of anti-VEGF and laser photocoagulation in the treatment of visual impairment due to diabetic macular edema: a systematic review and network meta-analysis. PLoS One 9, e102309. https://doi.org/10.1371/journal.pone.0102309.

Rezkallah, A., Mathis, T., Abukhashabah, A., Voirin, N., Malclès, A., Agard, É., Lereuil, T., Denis, P., Dot, C., Kodjikian, L., 2021. LONG-TERM incidence and risk factors of ocular hypertension following dexamethasone-implant injections: the SAFODEX-2 study. Retina 41, 1438–1445. https://doi.org/10.1097/IAE.0000000000003080.

Rodrigues, I.A., Sprinkhuizen, S.M., Barthelmes, D., Blumenkranz, M., Cheung, G., Haller, J., Johnston, R., Kim, R., Klaver, C., McKibbin, M., Ngah, N.F., Pershing, S., Shankar, D., Tamura, H., Tufail, A., Weng, C.Y., Westborg, J., Ielf, C., Yoshimura, N., Gillies, M.C., 2016. Defining a minimum set of standardized patient-centered outcome measures for macular degeneration. Am. J. Ophthalmol. 168, 1–12. https://doi.org/10.1016/j.ajo.2016.04.012.

Rosen, E., Rubowitz, A., Ferencz, J.R., 2009. Exposure to verteporfin or bevacizumab therapy for choroidal neovascularization secondary to punctate inner choroidopathy during pregnancy. Eye 23. https://doi.org/10.1038/eye.2008.218, 1479–1479.

Rosenbaum, P.R., Rubin, D.B., 1983. The central role of the propensity score in observational studies for causal effects. Biometrika 70, 41–55. https://doi.org/10.1093/biomet/70.1.41.

Rosenfeld, P.J., Brown, D.M., Heier, J.S., Boyer, D.S., Kaiser, P.K., Chung, C.Y., Kim, R.Y., MARINA Study Group, 2006. Ranibizumab for neovascular age-related macular degeneration. N. Engl. J. Med. 355, 1419–1431. https://doi.org/10.1056/NEJMoa054481.

Rubin, D.B., Thomas, N., 2000. Combining propensity score matching with additional adjustments for prognostic covariates. J. Am. Stat. Assoc. 95, 573–585. https://doi.org/10.2307/2669400.

Sado, D.M., 2002. Oxford textbook of clinical pharmacology and drug therapy. J. R. Soc. Med. 95, 472.

Saharinen, P., Eklund, L., Alitalo, K., 2017. Therapeutic targeting of the angiopoietin-TIE pathway. Nat. Rev. Drug Discov. 16, 635–661. https://doi.org/10.1038/nrd.2016.278.

Sahni, J., Patel, S.S., Dugel, P.U., Khanani, A.M., Jhaveri, C.D., Wykoff, C.C., Hershberger, V.S., Pauly-Evers, M., Sadikhov, S., Szczesny, P., Schwab, D., Nogocze, E., Osborne, A., Weikert, R., Fauser, S., 2019. Simultaneous inhibition of angiopoietin-2 and vascular endothelial growth factor-A with facomibucin in diabetic macular edema: BOULEVARD phase 2 randomized trial. Ophthalmology 126, 1155–1170. https://doi.org/10.1016/j.ophtha.2019.03.023.

Sarhianaki, A., Katsimpris, A., Petropoulos, I.K., Livieratou, A., Theoulakis, P.E., Katsimpris, J.M., 2012. Intravitreal administration of ranibizumab for idiopathic choroidal neovascularization in a pregnant woman. Klin Monbl Augenheilkd 229, 451–453. https://doi.org/10.1055/s-0031-1299027.

Sarmad, A., Lip, P.L., 2016. Intravitreal anti-vascular endothelial growth factor in early pregnancy and the complex management of advance diabetic retinopathy and maculopathy during pregnancy. Acta Ophthalmol. 94, e812–e813. https://doi.org/10.1111/aos.13083.

Schlegl, T., Waldstein, S.M., Bogunovic, H., Endstraßer, F., Sadeghipour, A., Philip, A.-M., Podkowinski, D., Gerendas, B.S., Langs, G., Schmidt-Erfurth, U., 2018. Fully automated detection and quantification of macular fluid in OCT using deep learning. Ophthalmology 125, 549–558. https://doi.org/10.1016/j.ophtha.2017.10.031.

Schmidt-Erfurth, U., Lang, G.E., Holz, F.G., Schlingemann, R.O., Lanzetta, P., Massin, P., Gerstner, O., Bouazza, A.S., Shen, H., Osborne, A., Mitchell, P., RESTORE Extension Study Group, 2014. Three-year outcomes of individualized ranibizumab treatment in patients with diabetic macular edema: the RESTORE extension study. Ophthalmology 121, 1045–1053. https://doi.org/10.1016/j.ophtha.2013.11.041.

Schmidt-Erfurth, U., Garcia-Arumi, J., Bandello, F., Berg, K., Chakravarthy, U., Gerendas, B.S., Jonas, J., Larsen, M., Tadayoni, R., Loewenstein, A., 2017. Guidelines for the management of diabetic macular edema by the European society of retina specialists (EURETINA). OPH 237, 185–222. https://doi.org/10.1159/000458539.

Schmidt-Erfurth, U., Reiter, G.S., Riedl, S., Seeböck, P., Vogl, W.-D., Blodi, B.A., Domalpally, A., Fawzi, A., Jia, Y., Sarraf, D., Bogunović, H., 2022. AI-based monitoring of retinal fluid in disease activity and under therapy. Prog. Retin. Eye Res. 86, 100972 https://doi.org/10.1016/j.preteyeres.2021.100972.

Schnabel, R., Tan, J., Cullip, T., Guinan, G., Cameron, C., 2016. Barriers to intravitreal injection therapy adherence in Dme patients in Australia. Value Health 19, A844. https://doi.org/10.1016/j.jval.2016.08.508.

Scott, A.W., Bressler, N.M., Folkes, S., Wittenborn, J.S., Jorkasky, J., 2016. Public attitudes about eye and vision health. JAMA Ophthalmol. 134, 1111–1118. https://doi.org/10.1001/jamaophthalmol.2016.2627.

Shah, C.P., Garg, S.J., Vander, J.F., Brown, G.C., Kaiser, R.S., Haller, J.A., Post-Injection Endophthalmitis (PIE) Study Team, 2011. Outcomes and risk factors associated with endophthalmitis after intravitreal injection of anti-vascular endothelial growth factor agents. Ophthalmology 118, 2028–2034. https://doi.org/10.1016/j.ophtha.2011.02.034.

Shah, J., Nguyen, V., Hunt, A., Mehta, H., Romero-Nuñez, B., Zarranz-Ventura, J., Viola, F., Bougamha, W., Barnes, R., Barthelmes, D., Gillies, M.C., Fraser-Bell, S., 2022. Characterization of poor visual outcomes of diabetic macular edema: the fight retinal blindness! Project. Ophthalmol. Retina. https://doi.org/10.1016/j.oret.2022.03.007. S2468653022001063.

Shen, W., Teo, K.Y.C., Wood, J.P.M., Vaze, A., Chidlow, G., Ao, J., Lee, S.-R., Yam, M.X., Cornish, E.E., Fraser-Bell, S., Casson, R.J., Gillies, M.C., 2020. Preclinical and clinical studies of photobiomodulation therapy for macular oedema. Diabetologia 63, 1900–1915. https://doi.org/10.1007/s00125-020-05189-2.

Sherman, R.E., Anderson, S.A., Dal Pan, G.J., Gray, G.W., Gross, T., Hunter, N.L., LaVange, L., Marinac-Dabic, D., Marks, P.W., Robb, M.A., Shuren, J., Temple, R., Woodcock, J., Yue, L.Q., Calififf, R.M., 2016. Real-world evidence — what is it and what can it tell us? N. Engl. J. Med. 375, 2293–2297. https://doi.org/10.1056/NEJMsb1609216.

Simunovic, M.P., Hunyor, A.P., Ho, L.-V., 2014. Vitrectomy for diabetic macular edema: a systematic review and meta-analysis. Can. J. Ophthalmol. 49, 188–195. https://doi.org/10.1016/j.cjjo.2013.11.012.

Slakter, J.S., Stur, M., 2005. Quality of life in patients with age-related macular degeneration: impact of the condition and benefits of treatment. Surv. Ophthalmol. 50, 263–273. https://doi.org/10.1016/j.survophthal.2005.02.007.

Smith, P.G., Morrow, R.H., Ross, D.A. (Eds.), 2015. Field Trials of Health Interventions: A Toolbox, 3rd Ed. Wellcome Trust-Funded Monographs and Book Chapters. OUP Oxford, Oxford (UK).

Solomon, S.D., Chew, E., Duh, E.J., Sobrin, L., Sun, J.K., VanderBeek, B.L., Wykoff, C.C., Gardner, T.W., 2017. Diabetic retinopathy: a position statement by the American Diabetes Association. Diabetes Care 40, 412–418. https://doi.org/10.2337/dc16-2641.

Sophie, R., Lu, N., Campochiaro, P.A., 2015. Predictors of functional and anatomic outcomes in patients with diabetic macular edema treated with ranibizumab. Ophthalmology 122, 1395–1401. https://doi.org/10.1016/j.ophtha.2015.02.036.

Starks, H., Diehr, P., Curtis, J.R., 2009. The challenge of selection bias and confounding in palliative care research. J. Palliat. Med. 12, 181–187. https://doi.org/10.1089/jpm.2009.9672.

Stevenson, M.R., Hart, P.M., Montgomery, A.-M., McCulloch, D.W., Chakravarthy, U., 2004. Reduced vision in older adults with age related macular degeneration interferes with ability to care for self and impairs role as carer. Br. J. Ophthalmol. 88, 1125–1130. https://doi.org/10.1136/bjo.2003.032383.

Storey, P.P., Pancholy, M., Wibbelsman, T.D., Obeid, A., Su, D., Borkar, D., Garg, S., Gupta, O., 2019. Rhegmatogenous retinal detachment after intravitreal injection of anti-vascular endothelial growth factor. Ophthalmology 126, 1424–1431. https://doi.org/10.1016/j.ophtha.2019.04.037.

Stratton, I.M., Kohner, E.M., Aldington, S.J., Turner, R.C., Holman, R.R., Manley, S.E., Matthews, D.R., 2001. UKPDS 50: risk factors for incidence and progression of retinopathy in Type II diabetes over 6 years from diagnosis. Diabetologia 44, 156–163. https://doi.org/10.1007/s001250051594.

Sullivan, L., Kelly, S.P., Glenn, A., Williams, C.P.R., McKibbin, M., 2014. Intravitreal bevacizumab injection in unrecognised early pregnancy. Eye (Lond) 28, 492–494. https://doi.org/10.1038/eye.2013.311.

Sultan, M.B., Zhou, D., Loftus, J., Dombi, T., Ice, K.S., Macugen 1013 Study Group, 2011. A phase 2/3, multicenter, randomized, double-masked, 2-year trial of pegaptanib sodium for the treatment of diabetic macular edema. Ophthalmology 118, 1107–1118. https://doi.org/10.1016/j.ophtha.2011.02.045.

Takamura, Y., Kubo, E., Akagi, Y., 2009. Analysis of the effect of intravitreal bevacizumab injection on diabetic macular edema after cataract surgery. Ophthalmology 116, 1151–1157. https://doi.org/10.1016/j.ophtha.2009.01.014.

Talks, S.J., Bhatia, D., Menon, G., Cole, A., Eleftheriadis, H., Downey, J., Chong, N.V., Sivaprasad, S., 2019. Randomised trial of wide-field guided PRP for diabetic macular oedema treated with ranibizumab. Eye 33, 930–937. https://doi.org/10.1038/s41433-019-03421-1.

Tarantola, R.M., Folk, J.C., Boldt, H.C., Mahajan, V.B., 2010. Intravitreal bevacizumab during pregnancy. Retina 30, 1405–1411. https://doi.org/10.1097/IAE.0b013e3181f57d58.

Teo, K.Y.C., 2023. Real-world evidence for neovascular age-related macular degeneration: a practical approach. Eye 37, 1–3. https://doi.org/10.1038/s41433-022-02151-x.

Teo, Z.L., Tham, Y.-C., Yu, M., Chee, M.L., Rim, T.H., Cheung, N., Bikbov, M.M., Wang, Y. X., Tang, Y., Lu, Y., Wong, I.Y., Ting, D.S.W., Tan, G.S.W., Jonas, J.B., Sabanayagam, C., Wong, T.Y., Cheng, C.-Y., 2021. Global prevalence of diabetic retinopathy and projection of burden through 2045: systematic review and meta-analysis. Ophthalmology 128, 1580–1591. https://doi.org/10.1016/j.ophtha.2021.04.027.

The Eye Diseases Prevalence Research Group*, 2004. The prevalence of diabetic retinopathy among adults in the United States. Arch. Ophthalmol. 122, 552–563. https://doi.org/10.1001/archophnt.122.4.552.

The Royal College of Ophthalmologists, 2012. The Royal College of Ophthalmologists Diabetic Retinopathy Guidelines.

Thomas, R.L., Dunstan, F., Luzio, S.D., Roy Chowdury, S., Hale, S.L., North, R.V., Gibbins, R.L., Owens, D.R., 2012. Incidence of diabetic retinopathy in people with type 2 diabetes mellitus attending the Diabetic Retinopathy Screening Service for Wales: retrospective analysis. BMJ 344, e874. https://doi.org/10.1136/bmj.e874.

Torjani, A., Mahmoudzadeh, R., Salabati, M., Cai, L., Hsu, J., Garg, S., Ho, A.C., Yonekawa, Y., Kuriyan, A.E., Starr, M.R., 2023. Factors associated with fluctuations in central subfield thickness in patients with diabetic macular edema using diabetic retinopathy clinical research protocols T and V. Ophthalmol. Sci. 3, 100226 https://doi.org/10.1016/j.xops.2022.100226.
Uemura, A., Fruttiger, M., D'Amore, P.A., De Falco, S., Joussen, A.M., Sennlaub, F., Brunck, L.R., Johnson, K.T., Lambrou, G.N., Rittenhouse, K.D., Langmann, T. 2021. VEGFR1 signaling in retinal angiogenesis and microinflammation. Prog. Retin. Eye Res. 84, 100954 https://doi.org/10.1016/j.preteyeres.2021.100954.

US Food and Drug Administration, 2018. Framework for FDA's Real-World Evidence Program.

Vandenbroucke, J.P., 2006. What is the best evidence for determining harms of medical treatment? CMAJ (Can. Med. Assoc. J.) 174, 645-646. https://doi.org/10.1503/cmaj.051484.

Varma, R., Choudhury, F., Klein, R., Chung, J., Torres, M., Azen, S.P., Los Angeles Latino Eye Study Group, 2010. Four-year incidence and progression of diabetic retinopathy and macular edema: The Los Angeles Latino Eye Study. Am. J. Ophthalmol. 149, 752-761. https://doi.org/10.1016/j.ajo.2009.11.014 e1-3.

Veritti, D., Sarao, V., Soppelsa, V., Lanzetta, P., 2021. Managing diabetic macular edema in clinical practice: systematic review and meta-analysis of current strategies and treatment options. Clin. Ophthalmol. 15, 375-385. https://doi.org/10.2147/OPTH.T236423.

Virgili, G., Parravano, M., Evans, J.R., Gordon, I., Lucenteforte, E., 2017. Anti-vascular endothelial growth factor for diabetic macular oedema: a network meta-analysis. Cochrane Database System Rev. 6, CD007419. https://doi.org/10.1002/14651858. CD007419.pub5.

von Elm, E., Altman, D.G., Egger, M., Pocock, S.J., Getzschze, P.C., Vandenbroucke, J.P., STROBE Initiative, 2008. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. J. Clin. Epidemiol. 61, 344-349. https://doi.org/10.1016/j.jclinepi.2007.11.008.

Wang, K., Wang, Y., Gao, L., Li, X., Li, M., Guo, J., 2008. Dexamethasone inhibits leukocyte accumulation and vascular permeability in retina of streptozotocin-induced diabetic rats via reducing vascular endothelial growth factor and intercellular adhesion molecule-1 expression. Biol. Pharm. Bull. 31, 1541-1546. https://doi.org/10.1248/bpb.31.1541.

Weiss, N.S., Koepsell, T.D., Psaty, B.M., 2008. Generalizability of results of randomized trials. Arch. Intern. Med. 168, 133-135. https://doi.org/10.1001/archinternmed.2007.30.

Weiss, M., Sim, D.A., Herold, T., Schumann, R.G., Liegl, R., Kern, C., Kreutzer, T., Schiefelbein, J., Rottmann, M., Priglinger, S., KortUEM, K.U., 2018. Compliance and adherence of patients with diabetic macular edema to intravitreal anti-vascular endothelial growth factor therapy in daily practice. Retiello 38, 2293-2300. https://doi.org/10.1097/IAE.00000000000001892.

Wells, J.A., Glassman, A.R., Ayala, A.R., Jampol, M.L., Aiello, L.P., Antoszyk, A.N., Arnold-Bush, B., Baker, C.W., Bressler, N.M., Browning, D.J., Elman, M.J., Ferris, F. L., Friedman, S.M., Melia, M., Pieramici, D.J., Sun, J.K., Beck, R.W., 2015. Aflibercept, bevacizumab, or ranibizumab for diabetic macular edema: N. Engl. J. Med. 372, 1193-1203. https://doi.org/10.1056/NEJMoa1414264.

Wells, J.A., Glassman, A.R., Ayala, A.R., Jampol, M.L., Bressler, N.M., Bressler, S.B., Brucker, A.J., Ferris, F.L., Hampton, G.R., Jhaveri, C., Melia, M., Beck, R.W., Diabetic Retinopathy Clinical Research Network, 2016a. Aflibercept, bevacizumab, or ranibizumab for diabetic macular edema: two-year results from a comparative effectiveness randomized clinical trial. Ophthalmology 123, 1351-1359. https://doi.org/10.1016/j.ophtha.2016.02.022.

Wells, J.A., Glassman, A.R., Jampol, M.L., Aiello, L.P., Antoszyk, A.N., Baker, C.W., Bressler, N.M., Browning, D.J., Connor, C.G., Elman, M.J., Ferris, F.L., Friedman, S. M., Melia, M., Pieramici, D.J., Sun, J.K., Beck, R.W., 2016b. Association of baseline visual acuity and retinal thickness with 1-year efficacy of aflibercept, bevacizumab, and ranibizumab for diabetic macular edema. JAMA Ophthalmol. 134, 127-134. https://doi.org/10.1001/jamaophthalmol.2015.4599.

Williams, P.D., Chong, D., Fuller, T., Callanan, D., 2016. Noninfectious vitritis after intravitreal injection of anti-vegf agents: variations in rates and presentation by medication. Retina 36, 909-913. https://doi.org/10.1097/IAE.00000000000000801.

Wong, T.Y., Sun, J., Kawasaki, R., Ruamvibonsuk, P., Gupta, N., Lansing, V.C., Maia, M., Mathenge, W., Moreker, S., Muqit, M.M.K., Resnikoff, S., Verdagueur, J., Zhao, P., Ferris, F., Aiello, L.P., Taylor, H.R., 2018. Guidelines on diabetic eye care: the international council of ophthalmology recommendations for screening, follow-up, referral, and treatment based on resource settings. Ophthalmology 125, 1608-1622. https://doi.org/10.1016/j.ophtha.2018.04.007.

Writing Committee for the UK Age-Related Macular Degeneration EMR Users Group, 2014. The neovascular age-related macular degeneration database: multicenter study of 92 976 ranibizumab injections: report 1: visual acuity. Ophthalmology 121, 1092-1101. https://doi.org/10.1016/j.ophtha.2013.11.031.

Wu, L., Martínez-Castellanos, M.A., Quiroz-Mercado, H., Arvalo, J.F., Berrocal, M.H., Farah, M.E., Maia, M., Roca, J.A., Rodriguez, J.F., Pan American Collaborative Retina Group (PACORES), 2008. Twelve-month safety of intravitreal injections of bevacizumab (Avastin): results of the pan-American collaborative retina study group (PACORES). Graefes Arch. Clin. Exp. Ophthalmol. 246, 81-87. https://doi.org/10.1007/s00417-007-0660-z.

Wu, Z., Huang, J., Sadda, S., 2010. Inadvertent use of bevacizumab to treat choroidal neovascularisation during pregnancy. A Case Report 39, 3.

Wykoff, C.C., Le, R.T., Khurana, R.N., Brown, D.M., Ou, W.C., Wang, R., Clark, W.L., Boyer, D.S., 2017. Outcomes with as-needed aflibercept and macular laser following the phase III VISTA DME trial: ENDURANCE 12-month extension study. Am. J. Ophthalmol. 173, 56-63. https://doi.org/10.1016/j.ajo.2016.09.029.

Wykoff, C.C., Ou, W.C., Khurana, R.N., Brown, D.M., Clark, W.L., Boyer, D.S., 2018. Long-term outcomes with as-needed aflibercept in diabetic macular oedema: 2-year outcomes of the ENDURANCE extension study. Br. J. Ophthalmol. 102, 631-636. https://doi.org/10.1136/bjophthalmol-2017-310941.

Wykoff, C.C., Abreu, F., Adamis, A.P., Basu, K., Eichenbaum, D.A., Haskova, Z., Lin, H., Loewenstein, A., Mohan, S., Pearce, I.A., Sakamoto, T., Schlottmann, P.G.,

Silverman, D., Sun, J.K., Wells, J.A., Willis, J.P., Tadayoni, R., Aaberg, T., Abbey, A., Abdulaeva, E., Abengoechea, S., Abraham, P., Ach, T., Adams, S., Civera, A.A., Adrian, S., Agostini, H., Alam, S., Alezzandri-Kamp, A., Alfaro, V., Aliseda, D., Alimony, A., Amat, P., Amini, P., Antoszyk, A., Arias, L., Asaria, R., Avila, M., Awh, C., Baumal, C., Jr, R.B., Bergstrom, C., Bertolucci, G., Bochow, T., Bolz, M., Borcz, E., Borda, J., Boyer, D., Bratko, G., Brent, M., Brown, J., Brown, D.M., Budzinskaya, M., Buffet, S., Burgess, S., Burton, B., Busquets, M., Cabrera, F., Cagini, C., Calzada, J., Campochiaro, P., Carlson, J., Castellarin, A., Cava, C., Chaikitmongkol, V., Chan, C., Chang, E., Chang, J., Chang, A., Charles, S., Chaudhry, N., Chee, C., Chen, J., Chen, F., Chen, S.-J., Cheong-Leen, R., Chiang, S., Chittum, M., Chow, D., Connolly, B., Cornut, P.L., Csaky, K., Danzig, C., Das, A., Daskalov, V., Desco, C., Dessouki, A., Dickinson, J., Do, B., Dollin, M., Dugel, P., Dusova, J., Eichenbaum, D., Eldem, B., Engstrom, R., Ernest, J., Escobar, J.J., Eposti, S., Eter, N., Falk, N., Farkas, A., Feiner, L., Feltgen, N., Fernandez, C., Vega, A.F., Ferrone, P., Figueira, J., Figueroa, J., Findl, O., Fine, H., Fortun, J., Fox, G.M., Foxman, S., Framme, C., Fraser-Bell, S., Fu, A., Fukutomi, A., Fung, N., Sola, F.F., Gallego-Pinazo, R., Garcia, R., Garcia-Layana, A., Gawecki, M., George, S., Ghanchi, F., Ghorayeb, G., Goldberg, R., Goldstein, M., Gomes, N., Ulla, F.G., Gonzalez, V., Greven, C., Gupta, S., Guzman, M., Harris, M., Hatz, K., Hau, Vivienne, Hau, Vincent, Hayashi, K., Heier, J., Herba, E., Hershberger, P., Hirakata, A., Ho, A., Holekamp, N., Honda, S., Hsu, J., Hu, H., Hurcikova, I, Ikeda, Y., Isernhagen, R., Ito, Y., Jackson, T., Jacoby, R., Jafree, A., Javey, G., Javid, C., Jhaveri, C., Johnson, M., Kacerik, M., Kaluzny, K., Kampik, D., Kang, S.W., Kapoor, K., Karabas, L., Kawasaki, T., Kerenyi, A., Khanani, A., Khurana, R., Kim, B., Kimura, K., Kishino, G., Kitano, S., Klein-Mascia, K., Kokame, G., Korobelnik, J.F., Kulikov, A., Kuriyan, A., Kwon, H., Kwon, R., Lai, T., Lai, C.-C., Laird, J., Lalonde, L., Lanzetta, P., Larsen, M., Laugesen, C., Lavinsky, D., Lebreton, O., Lee, S., Levy, J., Lipkova, B., Liu, M., Liu, J., Lohmann, C.P., London, N., Lorenz, K., Lotery, A., Rechy, D.L., Lujan, S., Ma, P., Maeno, T., Mahmood, S., Makkouk, F., Malik, K., Marcus, D., Margherio, A., Mastropasqua, L., Maturi, R., McCabe, F., McKibbin, M., Mehta, H., Menon, G., Mentes, J., Michalska-Malecka, K., Misheva, A., Mitamura, Y., Mitchell, P., Modi, Y., Mohamed, Q., Montero, J., Moore, J., Canton, V.M., Morori-Katz, H., Morugova, T., Murakami, T., Muzyka-Wozniak, M., Nardi, M., Nemcansky, J., Nester-Ostrowska, K., Neto, J., Newell, C., Nicolo, M., Nielsen, J., Noda, K., Obana, A., Ogata, N., Oh, H., Oh, K., Ohr, M., Oleksy, P., Oliver, S., Olivier, S., Osher, J., Ozcaliskan, S., Ozturk, B., Papp, A., Park, K.H., Parke, D.W., Parravano, M.C., Patel, Sugat, Patel, Sunil, Pearce, I., Pearlman, J., Penha, F., Perente, I., Perkins, S., Pertile, G., Petkova, I., Peto, T., Pieramici, D., Pollreisz, A., Pongsachareonnont, P., Pozdeyeva, N., Priglinger, S., Qureshi, J., Raczynska, D., Rajagopalan, R., Estudillo, J.R., Raskauskas, P., Rathod, R., Razavi, H., Regillo, C., Ricci, F., Rofagha, S., Romanzak, D., Romantowska-Dixon, B., Rosberger, D., Rosenblatt, I., Rosenblatt, B., Ross, A., Ruamvibonsuk, P., Moreno, J. M.R., Salomao, G., Sandhu, S., Sandner, D., Sararols, L., Sawada, O., Schadlu, R., Schlottmann, P., Schuart, C., Seitz, B., Seres, A., Sermet, F., Shah, S., Shah, A., Shah, R., Sharma, S., Sheidow, T., Sheth, Y., Shimouchi, A., Shimura, M., Sikorski, B., Silva, R., Singer, M., Singerman, L., Singh, R., Souied, E., Spinak, D.J., Spital, G., Steinle, N., Stern, J., Stoller, G., Stoltz, R., Stone, C., Stone, A., Suan, E., Sugimoto, M., Sugita, I., Sun, J., Sun, X., Suner, I., Szalzer, L., Szczeso, T., Tabassian, A., Tadayoni, R., Takagi, H., Takayama, K., Taleb, A., Talks, J., Tan, G., Tanabe, T., Taylor, S., Thach, A., Thompson, J., Tlucek, P., Torti, G., Guneva, D.T., Toth-Molnar, E., Uchiyama, E., Vajas, A., Varma, D., Varsanyi, B., Vassileva, P., Vaz-Pereira, S., Veith, M., Vela, J.I., Viola, F., Virgili, G., Vogt, G., Vorum, H., Weber, P., Wecke, T., Wee, R., Weger, M., Weishaar, P., Wells, J.A., Wickremasinghe, S., Williams, T.R., Williams, T., Williams, G., Wolf, A., Wolfe, J., Wong, J., Wong, D., Wong, I., Wong, R., Wowra, B., Wykoff, C.C., Wylegala, E., Yang, C.-H., Yasukawa, T., Yates, P., Yilmaz, G., Yiu, G., Yoon, Y.H., Yoreh, Yoshida, S., Yu, H. G., Yu, S.Y., Yurieva, T., Zacharias, L., Zakrzewska, K.Z., Zambrano, A., Zatorska, B., Zeolite, C., Zheutlin, J., 2022. Efficacy, durability, and safety of intravitreal faricamid with extended dosing up to every 16 weeks in patients with diabetic macular oedema (YOSEMITE and RHINE): two randomised, double-masked, phase 3 trials. Lancet 399, 741-755. https://doi.org/10.1016/S0140-6736(22)00018-6.

Wysong, A., Lee, P.P., Sloan, F.A., 2009. Longitudinal incidence of adverse outcomes of age-related macular degeneration. Arch. Ophthalmol. 127, 320-327. https://doi.org/10.1001/archophthalmol.2008.613.

Yanyali, A., Aytug, B., Horozoglu, F., Nohutcu, A.F., 2007. Bevacizumab (Avastin) for diabetic macular edema in previously vitrectomized eyes. Am. J. Ophthalmol. 144, 124-126. https://doi.org/10.1016/j.ajo.2007.02.048.

Yashkin, A.P., Hahn, P., Sloan, F.A., 2016. Introduction of anti-VEGF therapies for age-related macular degeneration did not raise risk of myocardial infarction, stroke, and death. Ophthalmology 123, 2225-2231. https://doi.org/10.1016/j.ophtha.2016.06.053.

Yau, J.W.Y., Rogers, S.L., Kawasaki, R., Lamoureux, E.L., Kowalski, J.W., Bek, T., Chen, S.-J., Dekker, J.M., Fletcher, A., Grauslund, J., Haffner, S., Hamman, R.F., Ikram, M.K., Kayama, T., Klein, B.E.K., Klein, R., Krishnaiah, S., Mayurasakorn, K., O'Hare, J.P., Orchard, T.J., Porta, M., Rema, M., Roy, M.S., Sharma, T., Shaw, J., Taylor, H., Tielsch, J.M., Varma, R., Wang, J.J., Wang, N., West, S., Xu, L., Yasuda, M., Zhang, X., Mitchell, P., Wong, T.Y., Meta-Analysis for Eye Disease (META-EYE) Study Group, 2012. Global prevalence and major risk factors of diabetic retinopathy. Diabetes Care 35, 556-564. https://doi.org/10.2337/dc11-1909.

Younis, N., Broadbent, M., Harding, S.P., Vora, J.P., 2003. Incidence of sight-threatening retinopathy in Type 1 diabetes in a systematic screening programme. Diabet. Med. 20, 758-765. https://doi.org/10.1046/j.1464-5491.2003.01035.x.

Yu, L., Liang, X.H., Ferrara, N., 2011. Comparing protein VEGF inhibitors: in vitro biological studies. Biochem. Biophys. Res. Commun. 408, 276-281. https://doi.org/10.1016/j.bbrc.2011.04.014.
Zacharias, L.C., Lin, T., Migon, R., Ghosn, C., Orilla, W., Feldmann, B., Ruiz, G., Li, Y., Burke, J., Kuppermann, B.D., 2013. Assessment of the differences in pharmacokinetics and pharmacodynamics between four distinct formulations of triamcinolone acetonide. Retina 33, 522–531. https://doi.org/10.1097/IAE.0b013e3182647f69.

Zhang, D.X., Saaddine, D.J.B., Chou, D.C.-F., Cotch, D.M.F., Cheng, D.Y.J., Geiss, D.L.S., Gregg, D.E.W., Albright, D.A.L., Klein, D.B.E.K., Klein, D.R., 2010. Prevalence of diabetic retinopathy in the United States, 2005–2008. JAMA, J. Am. Med. Assoc. 304, 649. https://doi.org/10.1001/jama.2010.1111.

Ziemann, S., Paetzolt, I., Grüßer, L., Coburn, M., Rossaint, R., Kowark, A., 2022. Poor reporting quality of observational clinical studies comparing treatments of COVID-19 – a retrospective cross-sectional study. BMC Med. Res. Methodol. 22, 23. https://doi.org/10.1186/s12874-021-01501-9.

Zins, M., Bonenfant, S., Carton, M., Coeuret-Pellicer, M., Guéguen, A., Gourmelen, J., Nachtigal, M., Ozguler, A., Quesnot, A., Ribet, C., Rodrigues, G., Serrano, A., Sitta, R., Brigand, A., Henny, J., Goldberg, M., 2010. The CONSTANCES cohort: an open epidemiological laboratory. BMC Publ. Health 10, 479. https://doi.org/10.1186/1471-2458-10-479.