A Phase 3 Multicenter, Randomized, Double Masked, Sham- Controlled Clinical Trial to Assess the Safety and Efficacy of Intravitreal Administration of Zimura (Complement C5 Inhibitor) in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 448
- 试验地点
- 204
- 主要终点
- The Mean Rate of Growth (Slope) Estimated Based on GA Area Measured by Autofluorescence (FAF) at 3 Time Points: Baseline, Month 6, and Month 12
研究概览
简要总结
The objectives of this study was to evaluate the safety and efficacy of avacincaptad pegol intravitreal administration in participants with geographic atrophy secondary to age-related macular degeneration (AMD)
详细描述
Participants were randomized in a 1:1 ratio to the following monthly treatment groups:
- Avacincaptad pegol 2 mg
- Sham
At Month 12, the participants in the avacincaptad pegol 2mg treatment group were re-randomized to receive the study drug either on a monthly basis or on an every other month basis
The participants initially randomized to sham treatment continued with monthly sham administration through Month 23
All participants had a final follow up visit at Month 24
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, Outcomes Assessor)
盲法说明
Participant, "Evaluating" Investigator, Reading Center Personnel, and Sponsor Personnel are 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
- •Subjects of either gender aged ≥ 50 years
- •Diagnosis of Non-foveal GA secondary to dry AMD
排除标准
- •Any prior treatment for AMD (dry or wet) 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 3 months of trial entry.
- •Any prior thermal laser in the macular region, regardless of indication
- •Any ocular or periocular infection (including blepharitis), or ocular surface inflammation in the past 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
Participants received avacincaptad pegol (ACP) 2 milligram (mg)/eye via intravitreal (IVT) injections monthly through Month 11 (Year 1). At month 12, participants were re-randomized to receive ACP 2 mg/eye via IVT injections monthly from month12 through month 23 (Year 2).
干预措施: Avacincaptad Pegol (Drug)
Sham
Participants received sham injections; through Month 11 (Year 1). At month 12, participants continued to receive monthly sham administration from month 12 through month 23 (Year 2).
干预措施: Sham (Drug)
Avacincaptad pegol and Sham
Participants who received ACP 2mg monthly through Month 11 (Year 1) were re-randomized at month 12, to receive ACP 2 mg/eye via IVT injections every other month at months 13, 15, 17, 19, 21, and 23 and sham injections at months 12, 14, 16,18, 20, and 22.
干预措施: Avacincaptad Pegol (Drug)
结局指标
主要结局
The Mean Rate of Growth (Slope) Estimated Based on GA Area Measured by Autofluorescence (FAF) at 3 Time Points: Baseline, Month 6, and Month 12
时间窗: Baseline to month 12
GA was associated with age-related macular degeneration (AMD) and caused bilateral, progressive, and irreversible loss of retinal tissue (photoreceptors, retinal pigment epithelium, and choriocapillaris) leading to a permanent loss of visual function and blindness. The least squares mean used to determine mean rate of change in GA growth (slope) was measured by FAF. LS mean \& SE were based on square-root transformation.
The Mean Rate of Growth (Slope) Estimated Based on GA Area Measured by FAF at 5 Timepoints: Baseline, Month 6, Month 12, Month 18, and Month 24
时间窗: Baseline to month 24
GA was associated with AMD and caused bilateral, progressive, and irreversible loss of retinal tissue (photoreceptors, retinal pigment epithelium, and choriocapillaris) leading to a permanent loss of visual function and blindness. The least square mean rate of GA growth (slope) was measured by FAF. LS mean \& SE were based on untransformed data.
次要结局
- Change From Baseline in Best Corrected Visual Acuity (BCVA) Using Early Treatment Diabetic Retinopathy Study (ETDRS) Letters at 24 Months(Baseline and month 24)
- Change From Baseline in Low Luminance (LL) BCVA Using ETDRS Letters at 24 Months(Baseline and month 24)
- Change From Baseline in Visual Function Questionnaire (VFQ-25) Composite Scores at 6, 12 and 18 Months(Baseline, months 6, 12, and 18)
- Change From Baseline in Visual Function Questionnaire (VFQ-25) Composite Scores at 24 Months(Baseline and month 24)
- Number of Participants With Categorical One-level Loss in VFQ-25 Subscale(Baseline up to month 24)
- Time to Persistent Vision Loss(Baseline up to month 24)