Diabetic Retinopathy, DRGLIA-MACNCT07526857
Epivascular Glia Regression and Macular Pigment Restoration After Faricimab in Diabetic Retinopathy
An observational study of Diabetic Retinopathy, DR, run by Federico II University at 1 site in Italy.
Trial 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 Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Diabetic Retinopathy, DR
- What is being tested?
- Faricimab Injection [Vabysmo] and Aflibercept (2.0 mg)
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2025to 1 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study population includes adult patients,, diagnosed with diabetic macular edema in diabetic retinopathy, treated with eylea 2 or faricimab
Who may be able to join
- diagnosis of diabetic macular edema, diabetic retinopathy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site
University of Naples, Federico II, Napoli, Napoli
Naples, Napoli, 80127
About this study
Official title: 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
- Conditions
- Diabetic Retinopathy, DR
- Being tested
- Faricimab Injection [Vabysmo], Aflibercept (2.0 mg)
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Faricimab Injection [Vabysmo]Drug
Also called Aflibercept Injection
One group treated with faricimab and the other one treated with Aflibercept
Aflibercept (2.0 mg)Drug
Aflibercept 2 mg intravitreal injection
| Study group | Role | What they receive |
|---|---|---|
| Diabetic macular edema treated with Eylea 2 mg | Diabetic macular edema treated with Eylea 2 mg Receives: Drug: Aflibercept (2.0 mg) | |
| Diabetic macular edema treated with Faricimab | Not described Receives: Drug: Faricimab Injection [Vabysmo] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epivascular glia regression
Epivascular glia regression
Measured: From January 2025 to January 2026
Macular pigment changes
Macular pigment changes
Measured: From January 2025 to January 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start1 Jan 2025
- Primary completion1 Jan 2026
- Study completion1 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Retinopathy, DRStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gilda Cennamo, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07526857
- Sponsor's protocol ID
- 05809858 Federico II
- Acronym
- GLIA-MAC
- Status last verified
- Apr 2026
- First submitted
- 7 Apr 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epivascular Glia Regression and Macular Pigment Restoration After Faricimab in Diabetic Retinopathy: A12 Month Multimodal Imaging Study
- ClinicalTrials.gov ID
- NCT07526857
- Acronym / sponsor ID
- GLIA-MAC / 05809858 Federico II
- Conditions
- Diabetic Retinopathy, DR
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Jan 2026 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetic macular edema treated with Eylea 2 mg | – | Drug: Aflibercept (2.0 mg)Diabetic macular edema treated with Eylea 2 mg |
| Diabetic macular edema treated with Faricimab | – | Drug: Faricimab Injection [Vabysmo] |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population includes adult patients,, diagnosed with diabetic macular edema in diabetic retinopathy, treated with eylea 2 or faricimab
Key inclusion criteria (1 listed)
- diagnosis of diabetic macular edema, diabetic retinopathy
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Faricimab Injection [Vabysmo]Also: Aflibercept InjectionOne group treated with faricimab and the other one treated with Aflibercept | Drug | Diabetic macular edema treated with Faricimab |
| Aflibercept (2.0 mg)Aflibercept 2 mg intravitreal injection | Drug | Diabetic macular edema treated with Eylea 2 mg |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Retinopathy, DR, run by Federico II University at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epivascular glia regression (time frame: From January 2025 to January 2026). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.