NCT06212297进行中（未招募）1 期
A Clinical Trial to Evaluate the Safety and Efficacy of Subretinal Re-Administration of LX101 to the Contralateral Eye in Subjects With Biallelic RPE65 Mutation-associated Inherited Retinal Dystrophy
Innostellar Biotherapeutics Co.,Ltd1 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2023年9月12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
- 9
- 试验地点
- 1
- 主要终点
- Safety: Incidence of adverse events (AEs) and serious adverse events (SAEs)
研究概览
简要总结
Up to nine subjects who have participated in the earlier LX101 clinical study, and who meet all study eligibility criteria, will receive LX101 administration in the previously uninjected, contralateral eye to evaluate the safety of bilateral, sequential subretinal administration of LX101.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prior subretinal administration of LX101 (unilateral)
- •≥ 6 years old Signed written informed consent
排除标准
- •Prior gene therapy except LX101 Active intraocular or periocular infections Lacking of sufficient surviving retinal cells Prior ocular surgery within six months Retinoid like compounds or precursors were taken within three months Complicating systemic diseases Clinically significant abnormal baseline laboratory values Using of any retinal toxic compounds
结局指标
主要结局
Safety: Incidence of adverse events (AEs) and serious adverse events (SAEs)
时间窗: 6 months
Incidence of ocular and non-ocular AEs and SAEs following LX102 subretinal injection
次要结局
- Mobility Test(6 months、12 months)
- Visual Acuity(6 months、12 months)
- Full-field Light Sensitivity Threshold (FST) Test(6 months、12 months)
研究者
研究点 (1)
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