Diabetic Macular Edema: Relevance of Staging Progression on Therapeutic Outcome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

608 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-01

Study Completion Date

2022-07-26

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.

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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.

Conditions

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Diabetic Macular Edema

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Early DME

Functional results after the loading therapeutic phase. The efficacy of different drugs (bevacizumab, ranibizumab, aflibercept, desamethazone) will be analyzed separately

intravitreal administration of bevacizumab/ranibizumab/aflibercept/desamethazone

Intervention Type DRUG

intravitreal administration

Advanced DME

Functional results after the loading therapeutic phase. The efficacy of different drugs (bevacizumab, ranibizumab, aflibercept, desamethazone) will be analyzed separately

intravitreal administration of bevacizumab/ranibizumab/aflibercept/desamethazone

Intervention Type DRUG

intravitreal administration

Severe DME

Functional results after the loading therapeutic phase. The efficacy of different drugs (bevacizumab, ranibizumab, aflibercept, desamethazone) will be analyzed separately

intravitreal administration of bevacizumab/ranibizumab/aflibercept/desamethazone

Intervention Type DRUG

intravitreal administration

Atrophic diabetic maculopathy

Functional results after the loading therapeutic phase. The efficacy of different drugs (bevacizumab, ranibizumab, aflibercept, desamethazone) will be analyzed separately

intravitreal administration of bevacizumab/ranibizumab/aflibercept/desamethazone

Intervention Type DRUG

intravitreal administration

Interventions

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intravitreal administration of bevacizumab/ranibizumab/aflibercept/desamethazone

intravitreal administration

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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.

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No