Finding protein biomarkers for AMD, diabetic retinopathy, and retinal detachment
Identification And Validation Of Biomarkers In Ophthalmological Diseases (Age-Related Macular Degeneration, Diabetic Retinopathy And Retinal Detachment) Through Clinical Proteomic Approaches
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 260 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione G.B. Bietti, IRCCS Academic / other |
| Locations | 1 site (Roma, Italy) |
| Trial ID | NCT07500324 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Roma, Italy
- IRCCS Fondazione G.B.Bietti — Roma, Italy, Italy (Recruiting)
Study contacts
- Study coordinator: Mariacristina Parravano, MD
- Email: mariacristina.parravano@fondazionebietti.it
- Phone: +390684009442
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.