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Completed

NCT Number: NCT05080803

Diabetic Macular Edema: Relevance of Staging Progression on Therapeutic Outcome

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

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

ESASO Scientific Projects

Lugano, CH-6901, Switzerland

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

intravitreal administration of bevacizumab/ranibizumab/aflibercept/desamethazone

Drug

intravitreal administration

Primary outcomes

  1. Functional and morphological improvement in DME after initial therapeutic loading phase, according to ESASO stage of progression of the disease.

    Time frame: Four months

    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.

Secondary outcomes

  1. Validation of ESASO DME staging classification

    Time frame: 3 months

    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

Sponsors and collaborators

Lead sponsor

European School of Advanced Studies in Ophthalmology

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Oct 18, 2021
Registry last updated
Sep 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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