An interventional study of Biological Sample Collection in Age-Related Macular Degeneration (AMD), Diabetic Retinopathy (DR) and Retinal Detachment, sponsored by Fondazione G.B. Bietti, IRCCS. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-02.
Sponsored by Fondazione G.B. Bietti, IRCCS · Not applicable, Interventional, and Diagnostic
This prospective interventional translational study aims to identify and validate protein biomarkers associated with major ophthalmological diseases, including age-related macular degeneration, diabetic retinopathy (DR), and retinal detachment (RD). A total of approximately 260 participants (cases and controls) will be enrolled at a single center.
Biological samples, including peripheral blood, tears, aqueous humor, vitreous humor, and subretinal fluid, will be collected during routine clinical and surgical procedures. Advanced clinical proteomics approaches will be applied to characterize molecular signatures associated with disease onset, progression, and response to treatment.
The study seeks to improve the understanding of disease pathophysiology and support the development of novel diagnostic and prognostic biomarkers in ophthalmology.
This is a single-center, prospective interventional translational study designed to identify and validate proteomic biomarkers in patients affected by age-related macular degeneration, diabetic retinopathy, and retinal detachment, compared with control subjects without retinal disease.
Study Population
Approximately 260 subjects will be enrolled, including:
180 patients (100 age-related macular degeneration, 50 diabetic retinopathy, 30 retinal detachment) 80 controls (cataract surgery or macular surgery patients without retinal disease). Participants will be recruited among patients routinely treated at IRCCS Fondazione G.B. Bietti.
Study Design and Procedures
All participants will undergo a baseline visit including:
Patients undergoing therapeutic procedures will also participate in a second visit (within 1-30 days), during which additional biological samples will be collected during routine clinical care, including:
Proteomic Analysis Collected biological matrices (ocular fluids and blood-derived components such as PBMCs and extracellular vesicles) will be analyzed using advanced clinical proteomics techniques. These include high-resolution mass spectrometry (Orbitrap-based platforms) combined with multiplex quantitative approaches (e.g., Tandem Mass Tags).
The study will follow a two-phase approach:
Biomarker discovery phase, aimed at identifying candidate protein biomarkers Validation phase, aimed at confirming their diagnostic and biological relevance Additional targeted analyses (e.g., ELISA) and functional studies (e.g., in vitro cellular models) may be performed to further characterize identified molecular pathways.
Objectives The primary objective is the identification and validation of protein biomarkers associated with age-related macular degeneration, diabetic retinopathy, and retinal detachment.
Secondary objectives include:
Characterization of molecular mechanisms underlying disease pathogenesis Identification of potential therapeutic targets Investigation of post-translational protein modifications (e.g., phosphoproteomics, ubiquitin-related signatures) Evaluation of surgical variables (e.g., vitreous fragmentation) in biomarker identification
Statistical Analysis Data will be analyzed using appropriate parametric and non-parametric statistical methods. Associations between clinical and molecular variables will be explored, with statistical significance defined as p \< 0.05.
Ethical and Data Management Considerations The study will be conducted in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines. All participants will provide written informed consent prior to enrollment. Data will be pseudonymized and handled in compliance with applicable data protection regulations (General Data Protection Regulatio)
1,459 studies on the registry are indexed under Macular Degeneration; 238 are open to participants now.
This study's planned enrollment of 260 is above the median of 56 across 985 interventional studies indexed under Macular Degeneration.
Browse Macular Degeneration studies →Fondazione G.B. Bietti, IRCCS is the lead sponsor of 19 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
For case subjects:
For control subjects:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biological sample collection during routine clinical care for proteomic biomarker analysis
Device: Biological Sample Collection
Biological samples will be collected from study participants during routine clinical evaluation and/or standard surgical procedures. Samples include peripheral blood, tears, aqueous humor, vitreous humor, and subretinal fluid, depending on the patient's clinical condition and scheduled treatment. Tear and blood samples will be obtained at baseline, while ocular fluids will be collected intraoperatively or during intravitreal procedures, without introducing additional risks or procedures beyond standard clinical care. All samples will be processed and analyzed using advanced clinical proteomics techniques, including high-resolution mass spectrometry, to identify and validate protein biomarkers associated with ophthalmological diseases.
Also known as: Collection of Ocular Fluids and Blood Samples, Ocular and Blood Sample Collection
Identification and Validation of Proteomic Biomarkers
Identification and validation of protein biomarkers associated with age-related macular degeneration, diabetic retinopathy, and retinal detachment through clinical proteomics analysis of biological samples (ocular fluids and blood-derived components).
Time frame: Up to 36 months
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Fondazione G.B. Bietti, IRCCS