NCT05392179已完成2 期
An Open-label, Phase II Study of ADX-2191 in Subjects With Retinitis Pigmentosa
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Number of participants with adverse events (AEs)
研究概览
简要总结
An open-label Phase II clinical trial, 8 (eight) subjects with retinitis pigmentosa due to rhodopsin mutations (including P23H) will be identified and treated with serial intravitreal injections of ADX-2191 in the worse seeing eye. Ocular structure and function will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Up to 8 adult patients age 18 or older
- •Diagnosis of retinitis pigmentosa due to rhodopsin gene mutation, including P23H
- •Impairment on Visual Field as determined by perimetry
排除标准
- •Age < 18 years
- •Previous inflammatory/infectious events involving the eyes
研究组 & 干预措施
ADX-2191 Three Injections
Experimental
干预措施: ADX-2191 (Drug)
ADX-2191 Six Injections
Experimental
干预措施: ADX-2191 (Drug)
结局指标
主要结局
Number of participants with adverse events (AEs)
时间窗: 16 weeks
Assessing the safety of ADX-2191 in patients with retinitis pigmentosa from AE collection
次要结局
- Change in visual acuity(16 weeks)
- Change in dark-adapted retinal sensitivity(16 weeks)
- Central retinal sensitivity(16 weeks)
- Assessment for change in central subfield foveal thickness and ellipsoid zone area/width(16 weeks)
研究者
研究点 (1)
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