Safety and Efficacy of Abicipar Pegol (AGN-150998) in Patients With Neovascular Age-related Macular Degeneration (CEDAR Study)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 939
- 试验地点
- 151
- 主要终点
- Percentage of Participants With Stable Vision at Week 52
研究概览
简要总结
This is a safety and efficacy study of abicipar pegol in participants with neovascular age-related macular degeneration.
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
- Quadruple (Participant, Care Provider, 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 age-related macular degeneration in at least 1 eye
- •Best corrected visual acuity of 20/40 to 20/320 in the study eye
- •Best corrected visual acuity of 20/200 or better in the non-study eye
排除标准
- •History of vitrectomy, macular surgery, or glaucoma surgery in the study eye
- •Cataract or refractive surgery in the study eye within the last 3 months
研究组 & 干预措施
Abicipar Pegol 2 mg (2Q8)
Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, Week 8 and every 8 weeks (2Q8) thereafter through Week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.
干预措施: Abicipar Pegol (Drug)
Abicipar Pegol 2 mg (2Q8)
Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, Week 8 and every 8 weeks (2Q8) thereafter through Week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.
干预措施: Sham Procedure (Other)
Abicipar Pegol 2 mg (2Q12)
Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, Week 12, and every 12 weeks (2Q12) thereafter through week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.
干预措施: Abicipar Pegol (Drug)
Abicipar Pegol 2 mg (2Q12)
Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, Week 12, and every 12 weeks (2Q12) thereafter through week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.
干预措施: Sham Procedure (Other)
Ranibizumab 0.5 mg (rQ4)
Ranibizumab (Lucentis®) 0.5 mg was administered to the study eye by intravitreal injection every 4 weeks (rQ4) from Day 1 through Week 96.
干预措施: Ranibizumab (Drug)
结局指标
主要结局
Percentage of Participants With Stable Vision at Week 52
时间窗: Baseline to Week 52
Stable vision was defined as a loss of fewer than 15 letters in BCVA compared to baseline. BCVA was measured using an eye chart and 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 percentage of participants with a BCVA loss of fewer than 15 letters are reported. The study eye is 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
- Mean Change From Baseline in BCVA in the Study Eye at Week 52(Baseline to Week 52)
- Percentage of Participants With a Gain of 15 or More ETDRS Letters in BCVA From Baseline in Study Eye at Week 52(Baseline to Week 52)
- Mean Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye at Week 52(Baseline to Week 52)
- Mean Change From Baseline in the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25) Composite Score in Study Eye at Week 52(Baseline to Week 52)