NCT00457470撤回2 期
A Phase 2, Multi-Stage, Multi-Center Trial Exploring The Safety And Efficacy Of AG-014699 In Subjects With Diffuse Diabetic Macular Edema (DME) Involving The Center Of The Retina
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- Pfizer
- 主要终点
- Change of retinal thickness at Day 15 or Day 25 depending on dosing regimen
研究概览
简要总结
This study will evaluate the safety and efficacy of AG-014699 in diabetic patients
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
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
- •diabetic patients, either man or woman, with diabetic retinopathy, at least 18 years of age
排除标准
- •patients treated with laser therapy within the last 90 days
- •patients with likelyhood to require cataract surgery within 3 months
- •Uncontrolled diabetes
结局指标
主要结局
Change of retinal thickness at Day 15 or Day 25 depending on dosing regimen
次要结局
- Proportion of subjects with reduction in retinal thickness from baseline in 2 months
- Change in retinal thickness for 2 months
- Change in visual acuity for 2 months
- ; Proportion of eyes experiencing an improvement in the degree of retinopathy at Day 28
研究者
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