NCT01013376已完成1 期
A Pilot, Single-Center, Open-Label Study of the Safety of MC-1101 in Both Normal Volunteers and Patients With Early Non-exudative Age-Related Macular Degeneration
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Ocular safety
研究概览
简要总结
The safety and comfort of repeated administrations of a topically-administered ophthalmic formulation of MC-1101 will be established through investigator assessments and subject reporting over a 3 day period. Safety assessments will be performed on both normal, healthy subjects as well as those with the signs and symptoms of early non-exudative age-related macular degeneration (dry AMD).
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinical diagnosis of dry AMD or;
- •Normal, healthy volunteer
排除标准
- •Uncontrolled systemic disease
- •Women who are pregnant, nursing, or planning a pregnancy during the study's duration
研究组 & 干预措施
Active
Experimental
Topical administration of MC-1101
干预措施: MC-1101 (Drug)
Vehicle
Placebo Comparator
Vehicle
干预措施: Vehicle (Drug)
结局指标
主要结局
Ocular safety
时间窗: 3 days
次要结局
- Choroidal blood flow assessment(3 days)
研究者
研究点 (1)
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