A Study 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
- 25
- 主要终点
- Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Week 16 Using the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale
研究概览
简要总结
This is a safety and efficacy study of abicipar pegol in patients with neovascular age-related macular degeneration to establish comparability between Japanese and non-Japanese.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Diagnosis of wet age-related macular degeneration in at least 1 eye
- •Best corrected visual acuity of 20/32 to 20/320 in the study eye and 20/200 or better in the fellow eye
排除标准
- •Hypersensitivity, allergy, or anaphylactic reaction to iodine
- •Cataract or refractive surgery within the last 3 months
- •History of vitrectomy
研究组 & 干预措施
abicipar pegol 1 mg
Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
干预措施: abicipar pegol (Drug)
abicipar pegol 1 mg
Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
干预措施: sham procedure (Other)
abicipar pegol 2 mg
Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
干预措施: abicipar pegol (Drug)
abicipar pegol 2 mg
Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
干预措施: sham procedure (Other)
ranibizumab 0.5 mg
Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
干预措施: ranibizumab (Drug)
结局指标
主要结局
Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Week 16 Using the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale
时间窗: Baseline, Week 16
BCVA is measured using an eye chart and is reported as the number of letters read correctly using the 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.
次要结局
- Change From Baseline in BCVA in the Study Eye at Week 20 Using the ETDRS Scale(Baseline, Week 20)
- Percentage of Patients With a BCVA Gain of 15 or More Letters in the Study Eye Using the ETDRS Scale(Baseline, Week 20)
- Percentage of Patients With a BCVA Gain of 10 or More Letters in the Study Eye Using the ETDRS Scale(Baseline, Week 20)
- Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye(Baseline, Week 16, Week 20)