NCT02732951已完成2 期
A Randomized, Double-masked, Placebo-controlled Exploratory Study to Evaluate Pharmacodynamics, Safety and Tolerability of Orally Administered BI 1026706 for 12 Weeks in Patients With Mild Visual Impairment Due to Center-involved Diabetic Macular Edema (DME)
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
- 105
- 试验地点
- 35
- 主要终点
- Change From Baseline in Central Subfield Foveal Thickness (CSFT) at Week 12
研究概览
简要总结
This is a proof of mechanism trial to explore the effect of BI 1026706 on the central retinal thickness and to evaluate safety and tolerability of BI 1026706 administered orally for 12 weeks in patients with mild vision impairment due to center-involved DME
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
- Double (Participant, Investigator)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
BI 1026706
Experimental
干预措施: BI 1026706 (Drug)
Placebo
Active Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Central Subfield Foveal Thickness (CSFT) at Week 12
时间窗: Baseline and Week 12
The change from baseline in CSFT at Week 12 and the BI 1026706 effect was compared between the BI 1026706 treatment group and the placebo group as measured by Spectral-domain Optical Coherence Tomography (SD-OCT). Baseline was defined as the CSFT value measured at the visit when patients were randomised. Mean presented here is an adjusted mean.
次要结局
- Number of Subjects With Serious Adverse Events (SAEs), Investigator Defined Drug-related Adverse Events (AEs) and Adverse Events of Special Interest (AESIs)(From first drug administration until 4 days after last drug administration, up to 89 days.)
研究者
研究点 (35)
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