NCT00701181终止2 期
A Phase II Prospective, Randomized, Multi-Center, Diabetic Macular Edema Dose Ranging, Comparator Study Evaluating The Efficacy And Safety Of PF-04523655 Versus Laser Therapy (DEGAS)
Quark Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 184 人开始时间: 2008年6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
- 终止
- 发起方
- 入组人数
- 184
- 试验地点
- 1
- 主要终点
- Mean Change from Baseline in the Best Corrected Visual Acuity Score
研究概览
简要总结
To evaluate the effectiveness of study drug in improving visual acuity compared to laser treatment in the patients with diabetic macular edema
详细描述
DEGAS termination decision date was December 17, 2010. Rationale: the objectives of the study could no longer be achieved. The study was not terminated for safety.
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
- Single (Participant)
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
- •Patients with Diabetes Mellitus (Type 1 or Type 2) Showing Diabetic Macular Edema in the Eye.
排除标准
- •Proliferative Diabetic Retinopathy in the Study Eye.
- •Subjects Receiving Concomitant Intravitreal Anti-VEGF Therapy.
研究组 & 干预措施
Laser
Active Comparator
This is a procedure - not a drug intervention.
干预措施: Laser Treatment (Procedure)
PF-04523655 (High)
Experimental
干预措施: PF-04523655 high (Drug)
PF-04523655 middle
Experimental
干预措施: PF-04523655 middle (Drug)
PF-04523655 low
Experimental
干预措施: PF-04523655 low (Drug)
结局指标
主要结局
Mean Change from Baseline in the Best Corrected Visual Acuity Score
时间窗: Month 24
次要结局
- Mean Changes in NEI-VFQ-25 Composite Score from Baseline(Month 24, 36)
- Plasma Concentration of PF-04523655(Week 1)
- Percent of Subjects Gaining Letters in the Best Corrected Visual Acuity Score from Baseline.(Month 24, 36)
- Incidence and Severity of Ocular and Systemic Adverse Events, as Identified by Ophthalmic Examination(Month 24, 36)
- Mean Change from Baseline in the Best Corrected Visual Acuity Score(Month 36)
- Mean Changes in Area of Fluorescein Leakage from Baseline(Month 24, 36)
- Percent of Subjects Losing Letters in the Best Corrected Visual Acuity Score from Baseline.(Month 24, 36)
- Mean Changes in Retinal Thickness from Baseline(Month 24, 36)
- Mean Changes in Macular Volume from Baseline(Month 24, 36)
研究者
研究点 (1)
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