Epivascular Glia Regression and Macular Pigment Restoration After Faricimab in Diabetic Retinopathy

The aim of the study is to evaluate in diabetic patients affected by diabetic retinopathy epivascular glia regression and macular pigment restoration after faricimab injection in diabetic retinopathy in a 1 year follow up

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Key information

Conditions

Diabetic Retinopathy, DR Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Retinopathy Endocrine System Diseases Eye Diseases Retinal Diseases Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Naples, Federico II, Napoli, Napoli

Naples, Napoli, 80127, Italy

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

diagnosis of diabetic macular edema, diabetic retinopathy

Exclusion criteria

previous ocular surgery, history of vitreoretinal and/or retinal vascular diseases, uveitis, myopia over 6 dioptres, significant corneal and/or lens opacity, glaucoma, ocular MNV related to other causes than nAMD, geographic atrophy, subretinal fibrosis, previous treatments for MNV

Treatment and study plan

Faricimab Injection [Vabysmo]

Drug

One group treated with faricimab and the other one treated with Aflibercept

Other names: Aflibercept Injection

Aflibercept (2.0 mg)

Drug

Aflibercept 2 mg intravitreal injection

Primary outcomes

Epivascular glia regression

Time frame: From January 2025 to January 2026

Epivascular glia regression
Macular pigment changes

Time frame: From January 2025 to January 2026

Macular pigment changes

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study title

Epivascular Glia Regression and Macular Pigment Restoration After Faricimab in Diabetic Retinopathy: A12 Month Multimodal Imaging Study

Acronym: GLIA-MAC

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Apr 13, 2026
Registry last updated: Apr 13, 2026

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.

Published trials that share one or more normalized conditions with this study.

Completed