NCT07526857

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 13, 2026

Completed
Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

1 year

First QC Date

April 7, 2026

Last Update Submit

April 7, 2026

Conditions

Diabetic Retinopathy, DR

Outcome Measures

Primary Outcomes (2)

  • Epivascular glia regression

    Epivascular glia regression

    From January 2025 to January 2026

  • Macular pigment changes

    Macular pigment changes

    From January 2025 to January 2026

Study Arms (2)

Diabetic macular edema treated with Eylea 2 mg

Diabetic macular edema treated with Eylea 2 mg

Drug: Aflibercept (2.0 mg)

Diabetic macular edema treated with Faricimab

Drug: Faricimab Injection [Vabysmo]

Interventions

Faricimab Injection [Vabysmo]DRUG

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

Also known as: Aflibercept Injection
Diabetic macular edema treated with Faricimab
Aflibercept (2.0 mg)DRUG

Aflibercept 2 mg intravitreal injection

Diabetic macular edema treated with Eylea 2 mg

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • diagnosis of diabetic macular edema, diabetic retinopathy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Naples, Federico II, Napoli, Napoli

Naples, Napoli, 80127, Italy

Location

MeSH Terms

Conditions

Diabetic Retinopathy

Interventions

faricimabaflibercept

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
GCennamo

Study Record Dates

First Submitted

April 7, 2026

First Posted

April 13, 2026

Study Start

January 1, 2025

Primary Completion

January 1, 2026

Study Completion

January 1, 2026

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)