Safety Extension Study to Evaluate the Biodegradation of the Brimonidine Tartrate Posterior Segment Drug Delivery System
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 215
- 主要终点
- Number of Patients With No Visible Implants in the Study Eye
研究概览
简要总结
This study will evaluate the biodegradation of the brimonidine tartrate posterior segment drug delivery system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Received the most recent sham or active study treatment of intravitreal Brimo PS DDS® no later than 36 months prior to entry into this study and have either completed their previous study, or have exited early from their previous study for any reason
- •Applicable studies: Previous Allergan intravitreal Brimo PS DDS® treatment studies
排除标准
- 未提供
研究组 & 干预措施
Brimo PS DDS® 400 μg (2 implants)
Patients who received Brimo PS DDS® 400 μg (2 implants) in a previous study.
干预措施: Brimo PS DDS® (Drug)
Brimo PS DDS® 400 μg (1 implant)
Patients who received Brimo PS DDS® 400 μg (1 implant) in a previous study.
干预措施: Brimo PS DDS® (Drug)
Brimo PS DDS® 200 μg (2 implants)
Patients who received Brimo PS DDS® 200 μg (2 implants) in a previous study.
干预措施: Brimo PS DDS® (Drug)
Brimo PS DDS® 200 μg (1 implant)
Patients who received Brimo PS DDS® 200 μg (1 implant) in a previous study.
干预措施: Brimo PS DDS® (Drug)
Brimo PS DDS® 100 μg (1 implant)
Patients who received Brimo PS DDS® 100 μg (1 implant) in a previous study.
干预措施: Brimo PS DDS® (Drug)
Brimo PS DDS® 50 μg (1 implant)
Patients who received Brimo PS DDS® 50 μg (1 implant) in a previous study.
干预措施: Brimo PS DDS® (Drug)
Sham
Patients who received sham in a previous study.
干预措施: Sham (Other)
结局指标
主要结局
Number of Patients With No Visible Implants in the Study Eye
时间窗: Month 36
Implants administered during the parent study are evaluated during this study to determine if they have completely degraded. The time frame is evaluated from the point of the first treatment in the parent study.
次要结局
- Number of Patients With Vision Loss in the Study Eye(Baseline of Parent Study, Month 36)