NCT07500324 Proteomic Biomarker Identification in AMD, Diabetic Retinopathy and Retinal Detachment
| NCT ID | NCT07500324 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione G.B. Bietti, IRCCS |
| Condition | Age-Related Macular Degeneration (AMD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 260 participants |
| Start Date | 2024-01-24 |
| Primary Completion | 2027-01 |
Trial Parameters
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Brief 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 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 electro