A Phase 2/3 Randomized, Double-Masked, Controlled Trial to Assess the Safety and Efficacy of Intravitreous Administration of Zimura™ (Anti-C5 Aptamer) in Patients With Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 286
- 试验地点
- 16
- 主要终点
- Change From Baseline in Geographic Atrophy as Measured by Fundus Autofluorescence
研究概览
简要总结
The objectives of this study were to evaluate the safety and efficacy of Zimura intravitreal (IVT) administration when administered in participants with geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD).
详细描述
Participants will receive monthly intravitreal injections of Zimura or Sham for 18 months.
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
- Double (Participant, Investigator)
盲法说明
The Reading Center team and Sponsor were also masked.
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
- •Participants of either gender aged ≥ 50 years
- •Diagnosis of Non-foveal GA secondary to dry AMD
排除标准
- •Evidence of Choroidal Neovascularization (CNV)
- •GA secondary to any condition other than AMD
- •Any prior treatment for AMD or any prior intravitreal treatment for any indication in either eye, except oral supplements of vitamins and minerals
- •Any intraocular surgery or thermal laser within three (3) months of trial entry
- •Any prior thermal laser in the macular region, regardless of indication
- •Any ocular or periocular infection in the twelve (12) weeks
- •Previous therapeutic radiation in the region of the study eye
- •Any sign of diabetic retinopathy in either eye
研究组 & 干预措施
Avacincaptad Pegol 1 mg [Part 1]
Participants received 1 mg of Avacincaptad Pegol in the study eye administered via IVT injection (50 µL) on Day 1 and monthly up to 18 months.
干预措施: Avacincaptad Pegol (Drug)
Avacincaptad Pegol 2 mg [Part 1]
Participants received 2 mg of Avacincaptad Pegol in the study eye administered via IVT injection (100 µL) on Day 1 and monthly up to 18 months.
干预措施: Avacincaptad Pegol (Drug)
Sham [Part 1]
Participants received a Sham injection of an empty, needleless syringe administered in the study eye on Day 1 and monthly up to 18 months.
干预措施: Sham (Other)
Avacincaptad Pegol 2 mg (Avacincaptad Pegol 2mg+Sham) [Part 2]
Participants received 2 mg of Avacincaptad Pegol in the study eye administered via IVT injection (100 µL) and a subsequent Sham administration on Day 1 and monthly up to 18 months.
干预措施: Avacincaptad Pegol (Drug)
Avacincaptad Pegol 2 mg (Avacincaptad Pegol 2mg+Sham) [Part 2]
Participants received 2 mg of Avacincaptad Pegol in the study eye administered via IVT injection (100 µL) and a subsequent Sham administration on Day 1 and monthly up to 18 months.
干预措施: Sham (Other)
Avacincaptad Pegol 4 mg (Avacincaptad Pegol 2mg+Avacincaptad Pegol 2mg) [Part 2]
Participants received 4 mg of Avacincaptad Pegol in the study eye administered via two consecutive IVT injections (2 x 100 µL) on Day 1 and monthly up to 18 months.
干预措施: Avacincaptad Pegol (Drug)
Sham (Sham+Sham) [Part 2]
Participants received two consecutive Sham injections of empty, needleless syringes administered in the study eye on Day 1 and monthly up to 18 months.
干预措施: Sham (Other)
结局指标
主要结局
Change From Baseline in Geographic Atrophy as Measured by Fundus Autofluorescence
时间窗: Baseline and 12 months
The least squares mean change in geographic atrophy (GA) from baseline to Month 12 was measured by fundus autofluorescence (FAF). The square root of the GA area was used in the analysis. Per statistical analysis plan, only the Zimura 2 mg and 4 mg groups were evaluated for this primary endpoint; the Zimura 1 mg group was for descriptive purposes only.
次要结局
- Change From Baseline in Low Luminance BCVA Using Early Treatment Diabetic Retinopathy Study Letters(Baseline and 12 months)
- Change From Baseline in Best Corrected Visual Acuity Using Early Treatment Diabetic Retinopathy Study Letters(Baseline and 12 months)