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2012年8月1日
概览
- 阶段
- 1 期
- 干预措施
- RetinoStat
- 疾病 / 适应症
- Age-Related Macular Degeneration
- 发起方
- Oxford BioMedica
- 入组人数
- 18
- 试验地点
- 3
- 主要终点
- The incidence of adverse events
- 状态
- 进行中(未招募)
- 最后更新
- 3个月前
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.
研究者
入排标准
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
Long Term follow up of patients who received RetinoStat in a previous study.
干预措施: RetinoStat
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)
研究点 (3)
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