Clinical trial Recruiting at 1 site Interventional Ages 18 and up

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 typeInterventional
Ages18 Years and up
SexAll
Enrollment260 (estimated)
SponsorFondazione G.B. Bietti, IRCCS
Academic / other
Locations1 site (Roma, Italy)
StatusRecruiting
StartedJanuary 24, 2024
Main results expectedJanuary 2027
Study endsJanuary 2027
Registry record updatedJune 2, 2026
Trial IDNCT07500324 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.