Diabetic Macular Edema: Relevance of Staging Progression on Therapeutic Outcome

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

Detailed Description
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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.

Official Title
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Diabetic Macular Edema: Relevance of Staging Progression on Therapeutic Outcome

Conditions
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Diabetic Macular Edema

Intervention / Treatment
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* Drug: intravitreal administration of bevacizumab/ranibizumab/aflibercept/desamethazone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria. Eligible eyes at the retrospective review Any stage of DME treated with a loading dose of 3 anti-VEGF (any type) or 1 IV dexamethasone (STEP 1). 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). VA at the time of both OCT examinations. Exclusion Criteria: Past ocular surgery of any kind (except for cataract surgery) or ocular pathologies other than diabetic retinopathy. Macular edema considered to be due to a cause other than diabetic macular edema. 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. Any ocular pathology or ocular condition other than diabetes that in the opinion of the investigator might affect macular edema. 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. History of YAG capsulotomy performed within two months before enrollment.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Early DME<br>Functional results after the loading therapeutic phase. The efficacy of different drugs (bevacizumab, ranibizumab, aflibercept, desamethazone) will be analyzed separately | Drug: intravitreal administration of bevacizumab/ranibizumab/aflibercept/desamethazone<br>* intravitreal administration<br>|
| Advanced DME<br>Functional results after the loading therapeutic phase. The efficacy of different drugs (bevacizumab, ranibizumab, aflibercept, desamethazone) will be analyzed separately | Drug: intravitreal administration of bevacizumab/ranibizumab/aflibercept/desamethazone<br>* intravitreal administration<br>|
| Severe DME<br>Functional results after the loading therapeutic phase. The efficacy of different drugs (bevacizumab, ranibizumab, aflibercept, desamethazone) will be analyzed separately | Drug: intravitreal administration of bevacizumab/ranibizumab/aflibercept/desamethazone<br>* intravitreal administration<br>|
| Atrophic diabetic maculopathy<br>Functional results after the loading therapeutic phase. The efficacy of different drugs (bevacizumab, ranibizumab, aflibercept, desamethazone) will be analyzed separately | Drug: intravitreal administration of bevacizumab/ranibizumab/aflibercept/desamethazone<br>* intravitreal administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional and morphological improvement in DME after initial therapeutic loading phase, according to ESASO stage of progression of the disease. | Visual acuity and morphological (OCT) stage of the disease (as described in ESASO DME classification) will be evaluated at time 0 and four months after the first injection of intravitreal dexamethasone or one month after the loading phase (3 monthly injections) with anti-VEGF. | Four months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validation of ESASO DME staging classification | After preliminary instruction on ESASO Staging system of DME, participating centers will evaluate the stage of DME at time 0 of every eye retrospectically selected to participate to the study. This staging will be than validated by the Coordinating Center, and the total concordance of staging (K index) will be used to validate the Classification | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetic macular edema, ESASO Classification, Therapy