A Study to Evaluate the Effectiveness of Intravitreal Aflibercept in Patients With Diabetic Macular Edema and/or Macular Edema Secondary to Retinal Vein Occlusion, Which Either Have or Have Not Been Pretreated for Their Disease

Study Overview
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Brief Summary
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AURIGA is designed to collect data from routine clinical practice on the effectiveness and utilization of intravitreal aflibercept in the treatment of visual impairment due to diabetic macular edema (DME) or macula edema secondary to retinal vein occlusion (RVO). The primary objective of this observational study (OS) is to evaluate the effectiveness of intravitreal aflibercept in 4 cohorts (with/without prior treatment in DME or macular edema secondary to RVO) in each of the participating countries. Additionally, utilization and treatment regimens in routine clinical practice will be described. Health care resources and services as well as health out-comes related to vision loss will be evaluated based on information collected using the AURIGA patient questionnaires.

Official Title
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An Observational Study Program to Investigate the Effectiveness of Intravitreal Aflibercept in Diabetic Macular Edema and/or Macular Edema Secondary to Retinal Vein Occlusion in a Real World Setting

Conditions
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Macular Edema

Intervention / Treatment
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* Drug: Aflibercept (Eylea, BAY86-5321)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: For DME -- Female and male patients of legal age, as defined by local regulations and local product labels, with visual impairment due to DME For macular edema secondary to RVO -- Female and male patients of legal age, as defined by local regulations and local product labels, with visual impairment due to macular edema secondary to RVO Patient for whom the decision to initiate treatment with aflibercept is made prior to and independent from study participation Signed informed consent. Exclusion Criteria: Any contraindications as listed in the local intravitreal aflibercept SmPC (summary of product characteristics) Current participation in any other clinical (interventional) study or in any other anti-VEGF study Receipt of systemic anti-VEGF and pro-VEGF treatment Structural damage to the center of the macula in either eye that is likely to preclude improvement in VA following the resolution of macular edema or any other condition expected to permanently limit VA outcomes over the course of the study Patients with prior retinal surgery Any prior treatment with aflibercept History of stroke or transient ischemic attacks within the last 6 months Laser photocoagulation (panretinal or macular) in the study eye within 90 days of Day 1 For patients with prior treatment (i.e. patients that previously have been treated with intravitreal anti-VEGF or steroids): Previous treatment of the study eye with anti-angiogenic drugs or laser within the last 3 months and patients with ocular surgery of the study eye within the last 3 months Intravitreal dexamethasone or triamcinolone in the study eye within the last 3 months Fluocinolone implant within the last 3 years Dexamethasone implant within the last 6 months For DME -- Concomitant therapy with any other agent to treat DME in the study eye. For macular edema secondary to RVO Patients who have received or who require pan retinal photocoagulation due to neovascularization Concomitant therapy with any other agent to treat macular edema secondary to RVO in the study eye.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| DME/naïve<br>patients with pre-treatment in diabetic macular edema (DME) | Drug: Aflibercept (Eylea, BAY86-5321)<br>* As per the treating physicians discretion.<br>|
| DME/pre-treatment<br>patients without pre-treatment in DME | Drug: Aflibercept (Eylea, BAY86-5321)<br>* As per the treating physicians discretion.<br>|
| RVO/pre-treatment<br>Macular edema secondary to RVO with prior treatment | Drug: Aflibercept (Eylea, BAY86-5321)<br>* As per the treating physicians discretion.<br>|
| RVO/naïve<br>Macular edema secondary to RVO without prior treatment | Drug: Aflibercept (Eylea, BAY86-5321)<br>* As per the treating physicians discretion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change of visual acuity (VA) from baseline to 12 months as evaluated in routine clinical practice per cohort and per country. | Analysis will be done per cohort and country. | Baseline and at 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change of visual acuity from baseline to 6, 12 and 24 months after first treatment | Secondary endpoint based on a pooled analysis over all countries and cohorts. | Up to 24 months | 
| Percentage of study eyes with pre-determined VA gains and losses (equivalent to 5, 10 and 15 Early Treatment Diabetic Retinopathy Study (ETDRS) letters closest to the visit 6, 12 and 24 months after first treatment | Analysis will be done per cohort and country. | Up to 24 months | 
| Mean change from baseline in central retinal thickness (CRT) as measured with optical coherence tomography (OCT) to closest to the visit 6, 12 and 24 months after first treatment | Analysis will be done per cohort and country. | Up to 24 months | 
| Proportion of study eyes with no fluid persistence as measured by spectral domain OCT (SD-OCT) closest to the visit 6, 12, and 24 months after first treatment | Analysis will be done per cohort and country. | Up to 24 months | 
| Treatment pattern based on the number of intravitreal aflibercept injections in the study eye during the first 6 months, the first year, and the 2-year treatment period | Analysis will be done per cohort and country. | Up to 2 years | 
| Mean number of visits regarding the study eye by type of visit during the first 6 months, the first year, and the 2-year treatment period | Analysis will be done per cohort and country. Including number of visits in clinics/ophthalmology practices other than the study center. | Up to 2 years | 
| Number of visits regarding the study eye in clinics/ophthalmology practices other than the study center during the first 6 months, the first year, and the 2-year treatment period |  | Up to 2 years | 
| Number of procedures per patient during the first 6 months, the first year, and the 2-year treatment period | Analysis will be done per cohort and country. The procedures contains: Slit lamp biomicroscopy Funduscopy examination Fluorescein angiographies | Up to 2 years | 
| Number of patients requiring additional drug treatment and what category of drug (patients switching to steroid treatment only or to other anti-VEGFs are excluded) | Analysis will be done per cohort and country. | Up to 2 years | 
| Number of performed laser treatments | Analysis will be done per cohort and country. | Up to 2 years | 
| Treatment pattern based on mean time between visits and mean time between aflibercept injections | Analysis will be done per cohort and country. | Up to 2 years | 
| Mean change in VA by number of injections during the first 6 months, the first year, and the 2-year treatment period. | Analysis will be done per cohort and country. | Up to 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Retinal Diseases, Diabetic Retinopathy, Diabetic macular edema, Retinal vein occlusion, Macular edema secondary to retinal vein occlusion, Intravitreal anti-VEGF (vascular endothelial growth factor), VEGF inhibitor, aflibercept, real world data, treatment pattern