EUCTR2017-003104-42-DE进行中（未招募）1 期
A Long-term Follow-up Study to Evaluate the Safety and Efficacy of RetinalGene Therapy in Subjects with Choroideremia Previously Treated with Adeno-Associated Viral Vector Encoding Rab Escort Protein-1 (AAV2-REP1) and in Subjects with X-Linked Retinitis Pigmentosa Previously Treated with Adeno-Associated Viral Vector Encoding RPGR (AAV8-RPGR) in an Antecedent Study
ightstaRx Ltd (A Biogen Company)0 个研究点目标入组 330 人开始时间: 2017年9月25日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 330
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
- Male
入选标准
- •CHM Participants:
- •a. Are willing and able to give informed consent for participation in the study, and
- •b. Have participated in and exited from an interventional study that investigated the safety and efficacy of a sub-retinal injection of AAV2-REP1 for CHM
- •XLRP Participants:
- •a. Are willing and able to give informed consent for participation in the study
- •b. Have received a sub-retinal injection of AAV8-RPGR for XLRP and have exited an antecedent study
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 330
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •In the opinion of the investigator and/or the Sponsor, it is not in the participant’s best interest to participate in the study.
研究者
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