Proteomic Biomarker Identification in Age-Related Macular Degeneration, Diabetic Retinopathy and Retinal Detachment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Biological Sample Collection.
- Who it may be relevant to
- Registry conditions: Age-Related Macular Degeneration (AMD), Diabetic Retinopathy (DR), Retinal Detachment. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Identification And Validation Of Biomarkers In Ophthalmological Diseases (Age-Related Macular Degeneration, Diabetic Retinopathy And Retinal Detachment) Through Clinical Proteomic Approaches
Overview
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.
Detailed description
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:
* Medical and ophthalmological history comprehensive eye examination (visual acuity, tonometry, biomicroscopy, ophthalmoscopy) * Non-invasive imaging (e.g., Optical Coherence Tomography, Optical Coherence Tomography Angiography) * Collection of tears and peripheral blood samples
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:
* Aqueous humor (via paracentesis) * Vitreous humor * Subretinal fluid (in retinal detachment surgery) Post-injection vitreous reflux (if applicable) All sampling procedures are performed as part of standard clinical or surgical practice and do not introduce additional risk to the patient.
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)
Interventions
- 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
Primary outcome measures
- Identification and Validation of Proteomic Biomarkers [Time frame: Up to 36 months]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Italy · 1 center
- IRCCS Fondazione G.B.Bietti — Roma
Identifiers
NCT: NCT07500324 · RET 03-23