NCT05080803

Diabetic Macular Edema: Relevance of Staging Progression on Therapeutic Outcome

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 608 (actual)
• Sponsor: European School of Advanced Studies in Ophthalmology · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: —

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.

Conditions

• Diabetic Macular Edema

Interventions

Type	Name	Description
DRUG	intravitreal administration of bevacizumab/ranibizumab/aflibercept/desamethazone	intravitreal administration

Timeline

• Start date: 2021-06-01
• Primary completion: 2021-12-23
• Completion: 2022-07-26
• First posted: 2021-10-18
• Last updated: 2023-09-28

Locations

1 site across 1 country: Switzerland

Regulatory

• FDA-regulated drug study