NCT07636590招募中不适用
A Multi-Center, Prospective, Non-Interventional Study in Subjects With Limbal Stem Cell Deficiency
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 10
研究概览
简要总结
The goal of this non-interventional, observational study is to describe the natural history, clinical course, and management patterns of subjects with limbal stem cell deficiency (LSCD).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A photopic BCVA in the prospective study eye(s) of ≤ 70 letters at the Screening and Day 1 visits AND a change of ≤ 10 letters in photopic BCVA at Day 1 compared to the Screening Visit
- •Qualifying LSCD diagnosis in the study eye(s) prior to enrollment at Day 1
- •Written confirmation that exclusions on retinal findings are met in the study eye(s) prior to enrollment at Day 1
- •Inflammation associated with LSCD or other non-infectious inflammation (e.g., dry eye, ocular rosacea, and blepharitis) that will not interfere with the subject's participation in the opinion of the investigator is permitted.
排除标准
- •Any active ocular infection in either eye at either the Screening or Day 1 visits
- •Active sterile iritis or uveitis in either eye at Screening or Day 1 visits
- •Screening visit retinal exam finding, in the opinion of the investigator, that would limit potential for visual acuity gain in the study eye(s)
- •Note: Other inclusion/exclusion criteria apply.
研究组 & 干预措施
Non-interventional
No product administration.
干预措施: Non-interventional (Other)
研究者
研究点 (10)
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