NCT06289452进行中（未招募）早期 1 期
An Open-label, Dose-escalation Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of IVB102 Injection in Subjects With X-linked Retinoschisis (XLRS)
InnoVec Biotherapeutics Inc.1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2024年3月8日最近更新:
适应症
试验速览
- 阶段
- 早期 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Incidence of AEs
研究概览
简要总结
The goal of this clinical trial is to evaluate the safety and efficacy of IVB102 injection in subjects with XLRS.
详细描述
This is a open label, dose escalation, single-center study. One eye of each participant will receive a single IVB102 injection by intravitreal injection. Participants will be followed for 52 weeks after which they will continue to be followed for up to 5 years after enrollment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 —（Child, Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Must be willing and able to provide written, signed informed consent.
- •Male individual at least 8 years of age with clinical diagnosis of XLRS caused by mutations in RS
- •Best corrected visual acuity (BCVA) in the study eye of less than or equal to 63 (corresponding to a Snellen acuity of 20/63).
- •Must agree to use effective barrier (male or female condom) of contraception before dosing and continuing one year after gene transfer.
排除标准
- •Lens, cornea, or other media opacities in the study eye that preclude adequate visualization and testing of the retina.
- •Pre-existing eye conditions that would contribute significantly to visual loss or increase the risk of an intravitreal injection (e.g. DR、RVO or large retinal detachment).
- •Any intraocular surgery in the study eye within 6 months prior to screening.
- •Use of topical carbonic anhydrase inhibitors within 3 months prior to screening.
- •Use of anticoagulants or anti-platelet agents within 7 days prior to study agent administration.
- •Prior receipt of any AAV gene therapy product.
- •Use of any investigational agent within 3 months prior to screening.
结局指标
主要结局
Incidence of AEs
时间窗: 52 weeks
Number and severity of overall and ocular Adverse Events (AEs)
Incidence of SAEs
时间窗: 52 weeks
Number and severity of overall and ocular Serious Adverse Events (SAEs)
Incidence of DLTs
时间窗: 4 weeks
Number and proportion of dose limited toxicity（DLTs）
次要结局
- ERG parameters(52 weeks)
- OCT imaging(52 weeks)
- Visual function(52 weeks)
研究者
研究点 (1)
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