A Randomized, Single-Masked , Long-Term, Safety and Tolerability Study of Intravitreal VEGF Trap-Eye in Subjects With Neovascular Age-related Macular Degeneration
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 157
- 主要终点
- Number of Participants With Adverse Events (AE)
研究概览
简要总结
Rollover study for subjects in prior VEGF Trap-Eye Phase I and II studies. Primary objective is to assess long-term safety and tolerability of continuing intravitreal treatment in subjects with wet age-related macular degeneration.
详细描述
Randomized, Single-Masked Phase II study for subjects previously enrolled in Phase I and II studies for wet age-related macular degeneration with VEGF Trap-Eye intravitreal injection as treatment.Long term (3 years) treatment is intended to measure safety and tolerability, as well as frequency of re-treatment and the effect of VEGF Trap-Eye on best corrected visual acuity (BCVA).
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
- Single (Participant)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prior participation in VEGF Trap-Eye Phase I and II studies
排除标准
- •Any ocular or systemic adverse events that would preclude participation
- •Presence of any condition that would jeopardize subject's participation
研究组 & 干预措施
Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye)
干预措施: VEGF Trap Eye (Drug)
结局指标
主要结局
Number of Participants With Adverse Events (AE)
时间窗: Baseline of this study to Wk 152
Number of participants with AEs summarized by category
次要结局
- Frequency (Number of Injections)(Baseline of this study to Wk 152)
- Mean Change From Baseline of Original Study in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score of Study Eye - Observed Values(Baseline of original study to Wk 156)