Epivascular Glia Regression and Macular Pigment Restoration After Faricimab in Diabetic Retinopathy (GLIA-MAC)

April 7, 2026 updated by: Gilda Cennamo, Federico II University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Napoli
      • Naples, Napoli, Italy, 80127
        • University of Naples, Federico II, Napoli, Napoli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The study population includes adult patients,, diagnosed with diabetic macular edema in diabetic retinopathy, treated with eylea 2 or faricimab

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Diabetic macular edema treated with Eylea 2 mg
Drug: Aflibercept (2.0 mg)
Aflibercept 2 mg intravitreal injection
Diabetic macular edema treated with Faricimab
Drug: Faricimab Injection [Vabysmo]
One group treated with faricimab and the other one treated with Aflibercept
Other Names:
  • Aflibercept Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Epivascular glia regression
Time Frame: From January 2025 to January 2026
Epivascular glia regression
From January 2025 to January 2026
Macular pigment changes
Time Frame: From January 2025 to January 2026
Macular pigment changes
From January 2025 to January 2026

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federico II University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2025

Primary Completion (Actual)

January 1, 2026

Study Completion (Actual)

January 1, 2026

Study Registration Dates

First Submitted

April 7, 2026

First Submitted That Met QC Criteria

April 7, 2026

First Posted (Actual)

April 13, 2026

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 7, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05809858 Federico II

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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