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
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 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
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)
Loading locations...
相似试验
已完成
1 期
Safety and Tolerability of Intravitreal VEGF Trap Formulations in Subjects With Neovacular AMDNeovascular Age Related Macular DegenerationNCT00383370Regeneron Pharmaceuticals20
已完成
3 期
Vascular Endothelial Growth Factor VEGF Trap-Eye:Investigation of Efficacy and Safety in Wet Age-Related Macular Degeneration(AMD)Macular DegenerationNCT00509795Regeneron Pharmaceuticals1,217
已完成
3 期
Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Central Retinal Vein Occlusion (CRVO)Macular Edema Secondary to Central Retinal Vein OcclusionNCT00943072Regeneron Pharmaceuticals189
已完成
3 期
Efficacy and Safety of VEGF Trap Eye in Diabetic Macular Edema (DME) With Central InvolvementMacular EdemaNCT01783886Bayer381
已完成
3 期
Intravitreal Aflibercept Injection in Vision Impairment Due to DMEDiabetes MellitusMacular EdemaNCT01331681Bayer406