NL-OMON52296尚未招募3 期
Phase 3 Randomized, Controlled Study of AAV5-hRKp.RPGR for the Treatment of X-linked Retinitis Pigmentosa Associated with Variants in the RPGR gene - MGT-RPGR-021 gene therapy study in patients with XLRP
Janssen-Cilag Internation NV0 个研究点目标入组 3 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 3
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 64（—）
入选标准
- •1.Male or female.
- •2.3 years of age or older.
- •3.Has X-linked retinitis pigmentosa (generalized rod-cone dystrophy) confirmed
- •by a retinal specialist AND has a predicted disease-causing sequence variant in
- •RPGR confirmed by a sponsor-approved laboratory.
- •Please refer to the protocol for additional inclusion criteria
排除标准
- •1.Has had ocular surgery within 3 months prior to screening or is anticipated
- •to require ocular surgery within 6 months after the study intervention
- •administration.
- •2.Any investigational ocular treatment or any other ocular treatment that could
- •confound the interpretation of the efficacy results or affect participant
- •compliance with the visit schedule.
- •3.Has undergone prior retinal surgery involving the macula, macular laser
- •photocoagulation, external-beam radiation therapy, transpupillary
- •thermotherapy, glaucoma filtration surgery or corneal surgery (except cataract
- •surgery or YAG capsulotomy).
- •4.History of an ocular implant, with the exception of an intraocular lens.
- •'Please refer to the protocol for additional exclusion criteria'
研究者
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