NCT05814952招募中不适用
An Open Label Dose Escalation Clinical Trial to Evaluate the Safety and the Efficacy of LX103 in Patients With X-Linked Retinoschisis (XLRS)
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2022年12月13日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Incidence of adverse events (AEs)
研究概览
简要总结
The goal of this study is to evaluate the safety and efficacy of LX103 treatment of X-linked retinoschisis. This study will enroll subjects aged ≥ 6 years old to receive a single unilateral intravitreal (IVT) injection of LX103 to evaluate its safety and efficacy.
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
- Male
- 接受健康志愿者
- 否
入选标准
- •Willing to sign the informed consent, and willing to attend follow-up visits.
- •Male individual at least 6 years of age with a diagnosis of XLRS and documented mutations in the RS1 gene.
- •The study eye must have a best-corrected E-ETDRS visual acuity letter score of less than or equal to 63.
排除标准
- •Any eye with disease that would interfere with the fundus examinations.
- •The study eye is receiving topical carbonic anhydrase inhibitor, or has received topical carbonic anhydrase inhibitors in the past three months.
- •The study eye has undergone intraocular surgery within six months prior to enrollment.
- •Participant has uncontrolled hypertension or diabetes.
结局指标
主要结局
Incidence of adverse events (AEs)
时间窗: 24 weeks
Incidence of adverse events (AEs) within 24 weeks of LX103 intravitreal injection at different doses
Incidence of serious adverse events (SAEs)
时间窗: 24 weeks
Incidence of serious adverse events (SAEs) within 24 weeks of LX103 intravitreal injection at different doses
次要结局
- Mean change from baseline in BCVA (LogMAR) in the study eye(24 weeks, 52 weeks)
- Mean change from baseline in central subfield thickness (CST) in the study eye(24 weeks, 52 weeks)
- Change from baseline in Electroretinogram (ERG) parameters in the study eye(24 weeks, 52 weeks)
研究者
Xiaodong Sun
PhD
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
研究点 (1)
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