EUCTR2016-000898-20-GB进行中（未招募）1 期
ong term follow-up study of participants following an open label, multi-centre, Phase I/II dose escalation trial of an adeno-associated virus vector (AAV2/5-OPTIRPE65) for gene therapy of adults and children with retinal dystrophy due to RPE65 deficiency (LCA2) - Long term follow-up gene therapy study for LCA2 OPTIRPE65
MeiraGTx UK Ltd0 个研究点目标入组 27 人开始时间: 2017年1月4日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 27
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Inclusion in the study will be limited to individuals who meet the following criteria:
- •Are able to give informed consent or assent, with or without the guidance of their parent/guardian where appropriate
- •Were enrolled and treated in the prior open-label, Phase I/II, dose escalation study involving singular intraocular administration of AAV2/5-0PTIRPE65
- •The contralateral eye may be untreated or treated with Voretigene Neparvovec.
- •Are willing to adhere to the protocol and long-term follow-up
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 9
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 18
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Individuals will be excluded if they are unwilling or unable to meet with the requirements of the study.
研究者
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