A Phase III, Multicenter, Randomized, Double-Masked, Sham-Controlled Study to Assess the Efficacy and Safety of Lampalizumab Administered Intravitreally to Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 906
- 试验地点
- 144
- 主要终点
- Change From Baseline in GA Area in Complement Factor I (CFI) Positive and Negative Participants at Week 48
研究概览
简要总结
This study is a Phase III, double-masked, multicenter, randomized, sham injection-controlled study evaluating the efficacy and safety of lampalizumab administered by intravitreal injections in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
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
- •Well demarcated area(s) of Geographic Atrophy (GA) secondary to Age-Related Macular Degeneration (AMD) with no evidence of prior or active choroidal neovascularization (CNV) in both eyes
排除标准
- •Ocular Exclusion Criteria: Study Eye
- •History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD
- •Previous laser photocoagulation for CNV, diabetic macular edema, retinal vein occlusion, and proliferative diabetic retinopathy
- •Previous intravitreal drug delivery (intravitreal corticosteroid injection, anti-angiogenic drugs, anti-complement agents, or device implantation) Ocular Exclusion Criteria: Both Eyes
- •GA in either eye due to causes other than AMD
- •Previous treatment with eculizumab, lampalizumab and/or fenretinide
研究组 & 干预措施
Lampalizumab Once in Every 4 Weeks (Q4W)
Participants will receive 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections for approximately 96 weeks.
干预措施: Lampalizumab (Drug)
Lampalizumab Once in Every 6 Weeks (Q6W)
Participants will receive 10 mg dose of lampalizumab administered by intravitreal injections for approximately 96 weeks.
干预措施: Lampalizumab (Drug)
Sham Comparator
Participants will receive sham comparator Q4W or Q6W for 96 weeks.
干预措施: Sham (Other)
结局指标
主要结局
Change From Baseline in GA Area in Complement Factor I (CFI) Positive and Negative Participants at Week 48
时间窗: Baseline, Week 48
For CFI profile, positive or negative biomarker status refers to the presence (carrier) or absence of the risk allele at CFI and at least one risk allele at complement factor H (CFH) or risk locus containing both complement component 2 and complement factor B (C2/CFB).The change in GA lesion area was measured by FAF and analysis of FAF images was performed by the central reading center. A positive change from baseline indicates an increase in size of GA lesion area (worsening; disease progression).
Change From Baseline in Geographic Atrophy (GA) Area, as Assessed by Fundus Autofluoresence (FAF) at Week 48
时间窗: Baseline, Week 48
The change in GA lesion area was measured by FAF and analysis of FAF images was performed by the central reading center. A positive change from baseline indicates an increase in size of GA lesion area (worsening; disease progression).
次要结局
- Percentage of Participants With Less Than 15 Letters Loss From Baseline in BCVA Score at Week 48(Week 48)
- Change From Baseline in Monocular Maximum Reading Speed as Assessed by MNRead Charts or Radner Reading Charts at Week 48(Baseline, Week 48)
- Change From Baseline in Number of Absolute Scotomatous Points as Assessed by Mesopic Micrometry at Week 48(Baseline, Week 48)
- Change From Baseline in Mean Macular Sensitivity as Assessed by Mesopic Microperimetry at Week 48(Baseline, Week 48)
- Change From Baseline in Best Corrected Visual Acuity (BCVA) Score as Assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart at Week 48(Baseline, Week 48)
- Change From Baseline in Low Luminance Visual Acuity (LLVA) as Assessed by ETDRS Chart Under Low Luminance Conditions at Week 48(Baseline, Week 48)
- Percentage of Participants With Less Than 15 Letters Loss From Baseline in LLVA Score at Week 48(Week 48)
- Change From Baseline in Binocular Reading Speed as Assessed by Minnesota Low-Vision Reading Test (MNRead) Charts or Radner Reading Charts at Week 48(Baseline, Week 48)
- Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item (NEI VFQ-25) Version Composite Score at Week 48(Baseline, Week 48)
- Change From Baseline in NEI VFQ-25 Near Activity Subscale Score at Week 48(Baseline, Week 48)
- Change From Baseline in NEI VFQ-25 Distance Activity Subscale Score at Week 48(Baseline, Week 48)
- Change From Baseline in Mean Functional Reading Independence (FRI) Index at Week 48(Baseline, Week 48)