A Study of Abicipar Pegol in Patients With Diabetic Macular Edema
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 151
- 主要终点
- Change from Baseline in Best Corrected Visual Acuity (BCVA)
研究概览
简要总结
This is a safety and efficacy study of abicipar pegol in patients with diabetic macular edema.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of diabetes mellitus (Type 1 or 2)
- •Decreased vision due to diabetic macular edema 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
- •Stroke or heart attack within the past 3 months
- •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
- •Laser photocoagulation of the study eye within the last 3 months
研究组 & 干预措施
ranibizumab
Ranibizumab (Lucentis®) administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 24.
干预措施: ranibizumab (Drug)
abicipar pegol 2 mg (group A)
Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4, 8, and 20, followed by a sham procedure at weeks 12, 16, and 24.
干预措施: abicipar pegol (Drug)
abicipar pegol 2 mg (group A)
Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4, 8, and 20, followed by a sham procedure at weeks 12, 16, and 24.
干预措施: sham procedure (Other)
abicipar pegol 2 mg (group B)
Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4, 8, 16, and 24, followed by a sham procedure at weeks 12 and 20.
干预措施: abicipar pegol (Drug)
abicipar pegol 2 mg (group B)
Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4, 8, 16, and 24, followed by a sham procedure at weeks 12 and 20.
干预措施: sham procedure (Other)
abicipar pegol 1 mg
Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4, 8, 16, and 24, followed by a sham procedure at weeks 12 and 20.
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, 8, 16, and 24, followed by a sham procedure at weeks 12 and 20.
干预措施: sham procedure (Other)
结局指标
主要结局
Change from Baseline in Best Corrected Visual Acuity (BCVA)
时间窗: Baseline, Week 28
次要结局
- Percentage of Patients with a BCVA Gain of ≥15 Letters in the Study Eye on the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale(Baseline, 28 Weeks)
- Percentage of Patients with a BCVA of ≥70 Letters(28 Weeks)
- Percentage of Patients with Resolution of Macular Edema(28 Weeks)
- Change from Baseline in Central Retinal Thickness (CRT) in the Study Eye(Baseline, Week 28)