Identification And Validation Of Biomarkers In Ophthalmological Diseases (Age-Related Macular Degeneration, Diabetic Retinopathy And Retinal Detachment) Through Clinical Proteomic Approaches
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- Identification and Validation of Proteomic Biomarkers
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Age < 18 years
- •Presence of infectious ocular diseases
- •Alterations in the electrophoretic profile of gamma globulins
研究组 & 干预措施
Ophthalmic Patients Undergoing Clinical Proteomic Sampling
Biological sample collection during routine clinical care for proteomic biomarker analysis
干预措施: Biological Sample Collection (Device)
结局指标
主要结局
Identification and Validation of Proteomic Biomarkers
时间窗: Up to 36 months
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).
次要结局
未报告次要终点