2024-513501-31-00招募中2 期
An Open Label Study to Determine the Long Term Safety, Tolerability and Biological Activity of SAR422459 in Patients with Stargardt’s Macular Degeneration
Sanofi-Aventis Recherche & Developpement1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2024年8月13日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- The incidence of Adverse Events
研究概览
简要总结
To evaluate the long-term safety and tolerability of SAR422459 in patients with Stargardt’s macular degeneration.
入排标准
- 年龄范围
- 0 years 至 64 years（18-64 Years, 0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Provide signed and dated written informed consent and any locally required authorization eg, HIPAA
- •Must have been enrolled in protocol TDU13583
- •Must have received a subretinal injection of SAR422459
- •Must have completed protocol TDU13583 to Week 48 or undergone an early discontinuation visit
排除标准
- •Did not receive SAR422459 as part of the TDU13583 protocol
结局指标
主要结局
The incidence of Adverse Events
The incidence of Adverse Events
次要结局
- Clinically important changes in ocular safety assessments
- Delay in retinal degeneration
研究者
Clinical Sciences and Operations
Scientific
Sanofi-Aventis Recherche & Developpement
研究点 (1)
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