Actively Recruiting
Identification And Validation Of Biomarkers In Ophthalmological Diseases (Age-Related Macular Degeneration, Diabetic Retinopathy And Retinal Detachment) Through Clinical Proteomic Approaches
Led by Fondazione G.B. Bietti, IRCCS · Updated on 2026-06-02
260
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a prospective interventional translational study to identify and validate protein biomarkers linked to major eye diseases such as age-related macular degeneration, diabetic retinopathy, and retinal detachment. The study aims to improve understanding of these diseases' development and support new diagnostic and prognostic tools in ophthalmology. Approximately 260 participants, including patients with these eye conditions and control subjects without retinal disease, will be enrolled at a single center. Participants will have biological samples collected during routine clinical care, such as peripheral blood, tears, and ocular fluids like aqueous humor, vitreous humor, and subretinal fluid during surgeries. The study involves baseline visits with eye examinations and imaging, followed by additional sample collection during therapeutic procedures when applicable. Advanced proteomics techniques, including high-resolution mass spectrometry, will be used to analyze these samples in phases focusing on biomarker discovery and validation. Throughout the study, participants will undergo comprehensive eye exams, medical history reviews, and non-invasive imaging. Samples will be collected without adding risk beyond routine care. Researchers will examine molecular signatures related to disease onset and progression and assess protein biomarkers over up to 36 months. Data will be statistically analyzed, and all personal information will be protected according to data privacy regulations.
CONDITIONS
Brief Title
Proteomic Biomarker Identification in Age-Related Macular Degeneration, Diabetic Retinopathy and Retinal Detachment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 65 18 years
- Ability to understand the study procedures and provide written informed consent
- Willingness and ability to comply with study procedures and visits
- 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
- Patients scheduled for cataract surgery with no documented retinal diseases
- Outpatients with no documented retinal diseases
- For retinal detachment subgroup: patients undergoing macular surgery or cataract surgery with attached retina
You will not qualify if you...
- Age < 18 years
- Presence of infectious ocular diseases
- Alterations in the electrophoretic profile of gamma globulins
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo a baseline evaluation including medical and ophthalmological history, eye examination, non-invasive imaging, and collection of tears and peripheral blood samples.
1 baseline visit (in-person)
Duration - Within 1 to 30 days after baseline
Participants undergoing therapeutic procedures have additional biological samples collected during routine clinical care or surgery without additional risk.
1 to 2 visits depending on treatment schedule
Duration - Up to 36 months
Participants are followed for up to 36 months to identify and validate proteomic biomarkers associated with ophthalmological diseases.
Follow-up visits as part of routine clinical care
Trial Site Locations
Total: 1 location
1
IRCCS Fondazione G.B.Bietti
Roma, Italy, Italy, 00184
Actively Recruiting
Research Team
M
Mariacristina Parravano, MD
T
Tommaso Rossi, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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