NCT02467634终止2 期
A Phase II Proof-of-Concept Study of the Safety and Efficacy of HUCNS-SC Subretinal Transplantation in Subjects With Geographic Atrophy of Age-Related Macular Degeneration
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 12
- 主要终点
- GA area based on fundus autofluorescence
研究概览
简要总结
A fellow eye controlled study of HUCNS-SC sub-retinal transplantation in subjects with bilateral GA AMD. All subjects will be assigned to HUCNS-SC transplantation.
详细描述
A fellow eye controlled study of HUCNS-SC sub-retinal transplantation in subjects with bilateral geographic atrophy (GA) age-related macular degeneration (AMD). All subjects will be assigned to HUCNS-SC transplantation. All subjects will be followed for efficacy and safety for 12 months. An independent data monitoring committee (IDMC) will review adverse events for the duration of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •GA associated with AMD in both eyes. Total area of GA determined by fundus autofluorescence.
- •BCVA of 20/320 or better in each eye at screening assessment
排除标准
- •Prior or concurrent choroidal neovascularization in either eye by clinical exam and/or fluorescein angiography as determined by the investigator or the reading center.
- •Retinal or macular disease of any other cause in either eye.
- •Diagnosis of glaucoma in either eye.
- •Uncontrolled intraocular pressure in either eye
- •Compromised renal function defined as eGFR <60mL/min and urine protein-to-creatinine ration >0.3 is spot urine collection.
- •History of or active autoimmune disease.
- •Previous organ, tissue or bone marrow transplantation.
- •Seropositive for HIV, hepatitis B or C, or CMV IgM
研究组 & 干预措施
HuCNS-SC
Experimental
HuCNS-SC sub-retinal transplantation
干预措施: HuCNS-SC sub-retinal transplantation (Biological)
结局指标
主要结局
GA area based on fundus autofluorescence
时间窗: 12 months
次要结局
未报告次要终点
研究者
研究点 (12)
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