Clinical trial NCT05080803: Diabetic Macular Edema: Relevance of Staging Progression on Therapeutic Outcome
Official title: Diabetic Macular Edema: Relevance of Staging Progression on Therapeutic Outcome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Macular Edema
Keywords: diabetic macular edema
ESASO Classification
Therapy
Lead sponsor: European School of Advanced Studies in Ophthalmology
Sponsor class: OTHER
First posted: 2021-10-18
Enrollment: 608
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: B. Major Eligibility Criteria

1. Age ≥ 50 years
2. Type 1 or type 2 diabetes
3. No history/presence of any other ocular/macular pathology
4. No history of IV/laser treatment in the past 8 months
5. No history of cataract or other ocular surgery in the past 6 months

Brief summary: Retrospective multi-center observational study on functional and morphological outcome of initial therapy for DME according to ESASO Morphologic Classification.

Detailed description: The ESASO morphologic classification of diabetic macular edema defines four stages of progression of the disease: early, advanced, chronic and atrophic maculopathy.

This grading is generated by the analysis of seven biomarkers that fully describe the level of retinal damage. Aim of this classification is to be a valid method for a comprehensive description of DME in scientific studies or clinical practice.

Given the recent publication of ESASO Classification, there aren't observations on the real relevance of grading DME on therapeutic outcome.

This retrospective study wants to give a preliminary answer to this important issue.

As a corollary outcome, this study will also evaluate the concordance of grading among participants.

Eligibility criteria: Inclusion Criteria. Eligible eyes at the retrospective review

1. Any stage of DME treated with a loading dose of 3 anti-VEGF (any type) or 1 IV dexamethasone (STEP 1).
2. OCT scans and retinal maps (radial/raster lines) at baseline (max 1 month before injection) and at one month (max 6 weeks) after the third anti-VEGF or at 3 months (max 16 weeks) after IV steroid injection (STEP 2).
3. VA at the time of both OCT examinations.

Exclusion Criteria:

1. Past ocular surgery of any kind (except for cataract surgery) or ocular pathologies other than diabetic retinopathy.
2. Macular edema considered to be due to a cause other than diabetic macular edema.
3. OCT examination suggesting that vitreoretinal interface abnormalities (e.g., a taut posterior hyaloid or epiretinal membrane) are the primary cause of the macular edema. In the case of ERM, an OCT scan must be sent to the Coordinating Center for approval.
4. Any ocular pathology or ocular condition other than diabetes that in the opinion of the investigator might affect macular edema.
5. History of any therapy (anti-VEGF treatment, focal/grid macular photocoagulation, intravitreous or peribulbar corticosteroids) for DME or diabetic retinopathy in the past 8 months.
6. History of YAG capsulotomy performed within two months before enrollment.

Primary outcomes:
measure: Functional and morphological improvement in DME after initial therapeutic loading phase, according to ESASO stage of progression of the disease.
timeFrame: Four months
Secondary outcomes:
measure: Validation of ESASO DME staging classification
timeFrame: 3 months
Other outcomes:
Locations:
city: Lugano
country: Switzerland
facility: ESASO Scientific Projects
Study officials:
References:
citation: Panozzo G, Cicinelli MV, Augustin AJ, Battaglia Parodi M, Cunha-Vaz J, Guarnaccia G, Kodjikian L, Jampol LM, Junemann A, Lanzetta P, Lowenstein A, Midena E, Navarro R, Querques G, Ricci F, Schmidt-Erfurth U, Silva RMD, Sivaprasad S, Varano M, Virgili G, Bandello F. An optical coherence tomography-based grading of diabetic maculopathy proposed by an international expert panel: The European School for Advanced Studies in Ophthalmology classification. Eur J Ophthalmol. 2020 Jan;30(1):8-18. doi: 10.1177/1120672119880394. Epub 2019 Nov 12.
citation: Panozzo G, Mura GD, Franzolin E, Giannarelli D, Albano V, Alessio G, Arrigo A, Casati S, Cassottana P, Contardi C, D'Aloisio R, Fasce F, Gusson E, Marchini G, Mastropasqua L, Niccolo M, Palmisano C, Pastore MR, Saviano S, Tognetto D, Bandello F. Early DMO: a predictor of poor outcomes following cataract surgery in diabetic patients. The DICAT-II study. Eye (Lond). 2022 Aug;36(8):1687-1693. doi: 10.1038/s41433-021-01718-4. Epub 2021 Aug 3.