Proteomic Biomarker Identification in 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
Fondazione G.B. Bietti, IRCCS
260 participants
Jan 24, 2024
INTERVENTIONAL
Summary
This prospective interventional translational study aims to identify and validate protein biomarkers associated with major ophthalmological diseases, including age-related macular degeneration (AMD), 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.
Eligibility
Inclusion Criteria5
- 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 Criteria1
- Age < 18 years Presence of infectious ocular diseases Alterations in the electrophoretic profile of gamma globulins
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Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07500324