Finding protein biomarkers for AMD, diabetic retinopathy, and retinal detachment
Official title: Identification And Validation Of Biomarkers In Ophthalmological Diseases (Age-Related Macular Degeneration, Diabetic Retinopathy And Retinal Detachment) Through Clinical Proteomic Approaches
Run by Fondazione G.B. Bietti, IRCCS · NCT07500324 · Data updated 2026-11-12
This project will test whether proteins found in blood and eye fluids can help diagnose or predict outcomes for adults with AMD, diabetic retinopathy, or retinal detachment.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 260 (estimated) |
| Sponsor | Fondazione G.B. Bietti, IRCCS Academic / other |
| Locations | 1 site (Roma, Italy) |
| Status | Recruiting |
| Started | January 24, 2024 |
| Main results expected | January 2027 |
| Study ends | January 2027 |
| Registry record updated | June 2, 2026 |
| Trial ID | NCT07500324 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults treated at IRCCS Fondazione G.B. Bietti with intermediate or advanced AMD, diabetic retinopathy, or retinal detachment, as well as control patients undergoing cataract or macular surgery without retinal disease.
✕Probably not a fit
People under 18, patients with infectious ocular disease, or those not undergoing clinical or surgical procedures that allow safe sample collection are unlikely to receive direct benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a single-center, prospective translational interventional effort enrolling about 260 participants including patients with AMD, diabetic retinopathy, retinal detachment, and control surgical patients. Clinical sampling includes peripheral blood, tears, and—when collected during routine care—aqueous humor, vitreous humor, and subretinal fluid. Advanced clinical proteomics will be applied to these biological matrices to identify molecular signatures linked to disease onset, progression, and treatment response. The goal is to validate protein biomarkers that improve understanding of disease mechanisms and support new diagnostic or prognostic tools.
Why it matters
Potential benefit: If successful, this could lead to new diagnostic or prognostic tests that detect retinal disease earlier or help guide treatment decisions.
How similar studies have gone: Prior proteomic research in ophthalmology has produced candidate biomarkers but few have reached clinical validation, so this study builds on earlier findings while focusing on validation.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years * Ability to understand the study procedures and provide written informed consent * Willingness and ability to comply with study procedures and visits For case subjects: * Patients with age-related macular degeneration (intermediate or advanced, including geographic atrophy or neovascular AMD) * Patients with diabetic retinopathy (non-proliferative or proliferative, with or without diabetic macular edema) * Patients undergoing surgery for primary or recurrent retinal detachment For control subjects: * Patients scheduled for cataract surgery with no documented retinal diseases (e.g., AMD, diabetic retinopathy, retinal vascular occlusions, or retinal epithelial disorders) * Outpatients with no documented retinal diseases * For retinal detachment subgroup: patients undergoing macular surgery (e.g., macular pucker or macular hole) or cataract surgery with attached retina Exclusion Criteria: * Age \< 18 years * Presence of infectious ocular diseases * Alterations in the electrophoretic profile of gamma globulins
Where it's running
-
IRCCS Fondazione G.B.Bietti
Roma, Italy, Italy Recruiting
Study contacts
- Study coordinator: Mariacristina Parravano, MD
- Email: mariacristina.parravano@fondazionebietti.it
- Phone: +390684009442
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
AI-assisted eye screening for diabetic retinopathy and age-related macular degeneration in outpatient clinics
This project will test whether the VeriSee AI software helps doctors find diabetic eye disease and macular degeneration earlier in adults with diabetes or people aged 50 and older.
-
VeriSee AI for screening macular degeneration and diabetic retinopathy
This trial will test whether the VeriSee AI software can help doctors screen for age-related macular degeneration in adults 50+ and diabetic retinopathy in diabetic adults 20+.
-
Automated AI system to detect diabetic retinopathy in adults with diabetes
A AI-based software device is being tested to automatically detect diabetic retinopathy from retinal images in adults with diabetes.
-
Biometry in Eyes with Silicon Oil After PPV
This study tests optical and ultrasound biometry in people with retinal detachment who are getting pars plana vitrectomy with silicone oil, to see how measurements compare before surgery and about a month after.
-
N-acetylcysteine for diabetic retinopathy in adults with type 2 diabetes
This study tests whether taking N-acetylcysteine for three months can help people with type 2 diabetes who have mild to moderate diabetic retinopathy.
-
Early imaging changes with faricimab versus biosimilar ranibizumab for diabetic retinal disease
This trial will see if faricimab or a biosimilar ranibizumab causes different early OCT and OCTA imaging changes in adults with diabetic retinopathy or diabetic macular edema who need anti-VEGF injections.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.