NCT01678872进行中（未招募）1 期
A Long Term Follow-up Study to Evaluate the Safety of RetinoStat® in Patients With Age-Related Macular Degeneration
Oxford BioMedica3 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2012年8月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 18
- 试验地点
- 3
- 主要终点
- The incidence of adverse events
研究概览
简要总结
The purpose of this study is to examine the long term safety of an experimental gene transfer agent, RetinoStat®, designed to treat neovascular age-related macular degeneration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have received a subretinal injection of RetinoStat
- •Must have been enrolled in Protocol RS1/001/10
排除标准
- •Did not receive RetinoStat® as part of the RS1/001/10 protocol
研究组 & 干预措施
Long Term Follow up
Other
Long Term follow up of patients who received RetinoStat in a previous study.
干预措施: RetinoStat (Drug)
结局指标
主要结局
The incidence of adverse events
时间窗: 14 years
The number of subjects with treatment emergent adverse events.
次要结局
- The change from baseline in BCVA.(14 years)
研究者
研究点 (3)
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