Evaluation of Abicipar Pegol in Patients With Neovascular Age-related Macular Degeneration
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 124
- 试验地点
- 37
- 主要终点
- Percentage of Participants With Stable Vision
研究概览
简要总结
The objective of this study is to evaluate abicipar pegol for safety and treatment effects in participants with neovascular age-related macular degeneration (AMD).
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female participants, 50 years of age or older at the time of informed consent
- •Best Corrected Visual Acuity (BCVA) ≤ 78 and ≥ 24 letters (20/32 to 20/320 Snellen equivalents, respectively) at Screening and at Baseline (Day 1, prior to treatment) visits in the study eye
- •BCVA of 34 letters (Snellen equivalent 20/200) or better at Baseline (Day 1, prior to treatment) in the non-study eye
排除标准
- •Active periocular, ocular, or intraocular infection at baseline (Day 1) (either eye)
- •Previous or concurrent macular laser treatment (study eye)
- •Cataract or refractive surgery within 3 months prior to baseline (study eye)
研究组 & 干预措施
Abicipar pegol 2 mg
Abicipar pegol 2 mg administered to the study eye by intravitreal injection on Day 1 and Weeks 4, 8, 16, and 24.
干预措施: Abicipar pegol (Drug)
结局指标
主要结局
Percentage of Participants With Stable Vision
时间窗: Baseline (Day 1) to Week 28
Stable vision was defined as a loss of fewer than 15 letters in Best Corrected Visual Acuity (BCVA) compared to baseline. BCVA was measured using an eye chart and is reported as the number of letters read correctly using the Early Treatment of Diabetic Retinopathy Study (ETDRS) Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The study eye was defined as the eye that meets the entry criteria. If both eyes met the entry criteria, the eye with the worse BCVA at baseline (Day 1) was selected as the study eye. If both eyes had same BCVA values at baseline (Day 1), then the participant had to select their non-dominant eye for treatment, or else the right eye was selected as the study eye.
次要结局
- Percentage of Participants With Loss of 15 or Less EDTRS Letters in BCVA From Baseline in the Study Eye(Baseline (Day 1) to Week 28)
- Change Form Baseline in BCVA in the Study Eye(Baseline (Day 1) to Week 28)
- Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye(Baseline (Day 1) to Week 28)
- Percentage of Participants With a Gain of 15 or More ETDRS Letters in BCVA From Baseline in the Study Eye(Baseline (Day 1), Week 28)