An Open Label, Two-Arm Study in Subjects With Chorioretinal Vascular Disease to Evaluate ABP 938 and Aflibercept (Eylea®) in a Prefilled Syringe
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 49
- 试验地点
- 4
- 主要终点
- Percentage of IVT Injections Successfully Administered
研究概览
简要总结
The primary objective of this study is to is to assess the ability of retina specialists to successfully administer, via an intravitreal (IVT) injection, a 2 mg dose of ABP 938, using the ABP 938 aflibercept prefilled syringe (PFS), compared to a 2 mg dose of aflibercept using the aflibercept PFS.
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
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
ABP 938
Participants will be randomized in a ratio of 2:1 to receive either a single IVT injection of ABP 938 in a PFS or a single injection of aflibercept in a PFS.
干预措施: ABP 938 (Drug)
Aflibercept
Participants will be randomized in a ratio of 2:1 to receive either a single IVT injection of ABP 938 in a PFS or a single injection of aflibercept in a PFS.
干预措施: Aflibercept (Drug)
结局指标
主要结局
Percentage of IVT Injections Successfully Administered
时间窗: Day of IVT injection (study day 1)
A successful injection was defined by whether the retinal specialist administering the IVT injection answered 'yes' to the following question: Did the PFS allow for the safe and effective administration of the prescribed dose? Percentage of successful injections and Clopper-Pearson 95% Confidence Interval is reported.
次要结局
- Number of Participants With Ocular Treatment Emergent Adverse Events (TEAEs) in Study Eye(Up to 28 days)
- Number of Participants With Serious Ocular TEAEs in Study Eye(Up to 28 days)
- Number of Participants With Non-ocular Serious TEAEs(Up to 28 days)