NCT07298291招募中不适用
A Phase 1, Single-Center, Prospective Study to Evaluate the Safety and Clinical Utility of Anterior Chamber Paracentesis for Proteomic Analysis in Patients With Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration
ClinOmicsAI2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年11月30日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Incidence of Treatment-Emergent Adverse Events
研究概览
简要总结
Study to evaluate the safety of routine diagnostic anterior chamber paracentesis (ACP) for proteomic profiling in patients with geographic atrophy (GA)
详细描述
The primary objective of this study is to assess the safety and tolerability of serial (two) AC paracentesis procedures, performed at Baseline and Month 1, for the collection of AH in subjects with Geographic Atrophy (GA) or dry Age-Related Macular Degeneration (dAMD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female subjects aged between 50 and 89 years, inclusive
- •For the GA cohort: Clinical diagnosis of GA secondary to AMD or dAMD in the study eye, confirmed by fundus autofluorescence imaging and spectral-domain optical coherence tomography (SD-OCT).
- •For the control cohort: No clinical evidence of retinal disease in either eye.
- •Best-corrected visual acuity (BCVA) of ≥20/200 in the study eye, as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) charts
- •Ability and willingness to provide written informed consent before any study-specific procedures.
排除标准
- •Presence of active ocular infection or inflammation in either eye at the time of screening.
- •History of intraocular surgery in the study eye within the three months preceding enrollment.
- •Intraocular pressure (IOP) greater than 21 mmHg in the study eye at screening
- •Use of systemic anticoagulation therapy that cannot be safely discontinued prior to ACP.
- •Pregnant or nursing women.
- •Known hypersensitivity or contraindication to any of the medications or procedures used in the study.
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events
时间窗: From enrollment to end of Visit 2
Incidence of Treatment-Emergent Adverse Events
次要结局
- Longitudinal changes in the Aqueous Humor proteome between Baseline (Day 0) and Month 1 (Day 30)(From Baseline (Day 0) to Month 1 (Day 30))
研究者
研究点 (2)
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