Diabetic Macular Edema: Relevance of Staging Progression on Therapeutic Outcome

European School of Advanced Studies in Ophthalmology

Status: Completed

Conditions: Diabetic Macular Edema

Treatments: Drug: intravitreal administration of bevacizumab/ranibizumab/aflibercept/desamethazone

Study type: Observational

Funder types: Other

Identifiers

NCT05080803

ESASO

Details and patient eligibility

About

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

Full 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.

Enrollment: 608 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

608 participants in 4 patient groups

Early DME

Description:

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

Treatment:

Drug: intravitreal administration of bevacizumab/ranibizumab/aflibercept/desamethazone

Advanced DME

Description:

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

Treatment:

Drug: intravitreal administration of bevacizumab/ranibizumab/aflibercept/desamethazone

Severe DME

Description:

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

Treatment:

Drug: intravitreal administration of bevacizumab/ranibizumab/aflibercept/desamethazone

Atrophic diabetic maculopathy

Description:

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

Treatment:

Drug: intravitreal administration of bevacizumab/ranibizumab/aflibercept/desamethazone