NCT01512966已完成3 期
An Open-label Phase III Study Evaluating the Safety and Tolerability of Repeated Doses of Intravitreal VEGF Trap-Eye in Japanese Subjects With Diabetic Macular Edema
Bayer18 个研究点 分布在 1 个国家目标入组 73 人开始时间: 2012年1月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 73
- 试验地点
- 18
- 主要终点
- Adverse Event collection
研究概览
简要总结
This study will assess the safety and tolerability of intravitreally (IVT) administered VEGF Trap-Eye in Japanese subjects with diabetic macular edema (DME) over the period of one year.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults ≥ 18 years with type 1 or 2 diabetes mellitus
- •Subjects with DME (diabetic macular edema) secondary to diabetes mellitus involving the center of the macula in the study eye
- •BCVA (best-corrected visual acuity) ETDRS (Early Treatment Diabetic Retinopathy Study) letter score of 73 to 24 (20/40 to 20/320) in the study eye
排除标准
- •Active proliferative diabetic retinopathy (PDR) in the study eye
- •Uncontrolled diabetes mellitus, as defined by HbA1c >12%
- •Only 1 functional eye even if that eye is otherwise eligible for the study
研究组 & 干预措施
VTE 2Q4 first, then VTE 2Q8
Experimental
VEGF Trap-Eye [BAY86-5321; EYLEA (aflibercept) Injection] 2 mg Q4 (VTE 2Q4) administered every 4 weeks from Week 0 to Week 16, followed by every 8 weeks until Week 48 (2Q8)
干预措施: VEGF Trap-Eye (BAY86-5321) (Biological)
结局指标
主要结局
Adverse Event collection
时间窗: Week 52
次要结局
- Change from baseline in BCVA (best corrected visual acuity) letter score(Week 52)
研究者
研究点 (18)
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