Safety and Efficacy of Abicipar Pegol (AGN-150998) in Patients With Neovascular Age-related Macular Degeneration (SEQUOIA Study)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 949
- 试验地点
- 187
- 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
- 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 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, and Week 8, followed by injections every 8 weeks 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, and Week 8, followed by injections every 8 weeks 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, and Week 12, followed by injections every 12 weeks 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, and Week 12, followed by injections every 12 weeks 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 (rQ4)
Ranibizumab (Lucentis®) was administered to the study eye by intravitreal injection every 4 weeks 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 vision loss of fewer than 15 letters in Best-corrected Visual Acuity (BCVA) from baseline. 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. The percentage of participants with a BCVA loss of fewer than 15 letters are reported. Study eye was defined as the eye that meets the entry criteria. If both the eyes met all of the entry criteria, the eye with worse BCVA at baseline (Day 1) was selected. If BCVA values for both eyes were identical then participant had to select the non-dominant eye, or else right eye was selected as study eye.
次要结局
- Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) in the 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)
- Percentage of Participants With BCVA Gain of More Than 15 Letters From Baseline 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 at Week 52(Baseline to Week 52)