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临床试验/NCT01678872
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.

注册库
clinicaltrials.gov
开始日期
2012年8月1日
结束日期
2029年3月1日
最后更新
3个月前
研究类型
Interventional
研究设计
Single Group
性别
All

研究者

发起方
Oxford BioMedica
责任方
Sponsor

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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