NCT01802866已完成2 期
A Phase 2b/3 Multicenter, Randomized, Double-Masked, Dose-Ranging Study Comparing the Efficacy and Safety of Emixustat Hydrochloride (ACU-4429) With Placebo for the Treatment of Geographic Atrophy Associated With Dry Age-Related Macular Degeneration
Kubota Vision Inc.0 个研究点目标入组 508 人开始时间: 2013年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 508
- 主要终点
- Change from baseline in the total area of the GA lesion(s)
研究概览
简要总结
The purpose of this study is to determine if emixustat hydrochloride (ACU-4429) reduces the rate of progression of geographic atrophy compared to placebo in subjects with dry age-related macular degeneration.
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
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females, age ≥55 years.
- •Clinical diagnosis of GA associated with AMD
- •Able and willing to provide written informed consent.
- •Able to reliably administer oral medication by self or with available assistance.
排除标准
- •Active CNV or presence of an active ocular disease.
- •Known serious allergy to the fluorescein sodium for injection in angiography.
- •Pre-specified laboratory abnormalities at screening.
- •Treatment with any investigational study drug within 30 days of screening or device (within 60 days of screening)
- •History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding
- •Female subjects who are pregnant or lactating.
- •Female subjects of childbearing potential and male subjects who are not surgically sterile who are not willing to practice a medically accepted method of birth control from screening through 30 days after completion of the study.
- •Unstable or poorly controlled medical or ophthalmic conditions
研究组 & 干预措施
ACU-4429 2.5 mg
Experimental
2.5 mg tablet
干预措施: ACU-4429 (Drug)
ACU-4429 5 mg
Experimental
5 mg tablet
干预措施: ACU-4429 (Drug)
ACU-4429 10 mg
Experimental
10 mg tablet
干预措施: ACU-4429 (Drug)
Placebo
Placebo Comparator
Includes identical tablets with only inactive ingredients (0 mg).
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in the total area of the GA lesion(s)
时间窗: 24 months
次要结局
- Change from baseline in BCVA score(24 months)
- Frequency of AEs, discontinuations due to AEs, or dose modifications; severity and seriousness of AEs(24 months)
研究者
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