NCT00429936已完成2 期
A Phase II Multicenter, Randomized, Double-Masked, Placebo-Controlled, Dose-Comparison Study of the Safety and Efficacy of Fenretinide in the Treatment of Geographic Atrophy in Subjects With Age-Related Macular Degeneration
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
- 245
- 主要终点
- GA lesion progression
研究概览
简要总结
The purpose of this phase II study is to determine the efficacy of fenretinide in the treatment of geographic atrophy (GA) in subjects with the dry form of age-related macular degeneration (AMD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •males or females, 50 to 89 years of age
- •must have GA from AMD in one or both eyes
排除标准
- •GA due to any disease other than AMD (eg, drug-induced)
研究组 & 干预措施
100 mg fenretinide softgel capsules
Active Comparator
Three (3) 100-mg fenretinide softgel capsules
干预措施: Fenretinide (Drug)
Fenretinide and placebo softgel capsules
Active Comparator
One (1) 100-mg fenretinide softgel capsule and two (2) placebo softgel capsules
干预措施: Fenretinide (Drug)
Placebo softgel capsules
Placebo Comparator
Three (3) placebo softgel capsules
干预措施: Fenretinide (Drug)
结局指标
主要结局
GA lesion progression
时间窗: 1 year
次要结局
未报告次要终点
研究者
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