NCT02121522已完成2 期
A Single Arm Open Label Study to Evaluate the Pharmacodynamics and Safety of a 4 wk Treatment With BI 144807 in Patients With Newly Diagnosed Wet Age Related Macular Degeneration (wAMD)
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
- 14
- 试验地点
- 10
- 主要终点
- Change From Baseline in CRT as Measured by SD-OCT on Day 29
研究概览
简要总结
The present trial will use an open label design to investigate the effect of BI 144807 on central 1-mm retinal thickness and presence of neovascular leakage in newly diagnosed wAMD patients. A further objective is to collect data on adverse events, vital signs, ECG and clinical laboratory parameters of BI 144807 in the same patient group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
BI 144807
Experimental
twice daily
干预措施: BI 144807 (Drug)
结局指标
主要结局
Change From Baseline in CRT as Measured by SD-OCT on Day 29
时间窗: Baseline (day 1) and day 29
Change from baseline in central 1-mm retinal thickness (CRT) as measured by spectral domain optical coherence tomography (SD-OCT) on day 29.
次要结局
- Change From Baseline in Neovascular Leakage Area as Assessed by FA on Day 29(Baseline and day 29)
研究者
研究点 (10)
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