About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 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)
Disqualifiers
Age < 18 years
Presence of infectious ocular diseases
Alterations in the electrophoretic profile of gamma globulins
Trial design
Single group
Treatments tested in this trial
Biological Sample Collection
DeviceBiological 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.
Treatment groups
Trial outcomes
Primary outcomes
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).
Sponsors and contacts
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