A Phase 3, Multicenter, Randomized, Parallel-Group, Double-Masked, 2-Arm, Sham Controlled Study of the Efficacy, Safety, and Tolerability of ANX007 (Vonaprument) Administered by Intravitreal Injection in Participants With Dry Age-Related Macular Degeneration With Geographic Atrophy
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 659
- 试验地点
- 256
- 主要终点
- Proportion of patients experiencing a best corrected visual acuity (BCVA) ≥15-letter loss from baseline through the primary timepoint as assessed by the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at any two consecutive visits.
研究概览
简要总结
The primary purpose of the study is to determine if IVT injections of vonaprument every month reduce vision loss in participants with dry AMD with GA.
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
- •Diagnosis of dry AMD with GA as determined by the Investigator and confirmed by the independent Central Reading Center.
排除标准
- •Geographic atrophy due to other causes than AMD such as Stargardt disease, cone-rod dystrophy, pathologic myopia, or toxic maculopathies (for example, plaquenil maculopathy) in either eye.
- •NOTE: Other protocol-defined inclusion and exclusion criteria apply.
研究组 & 干预措施
Vonaprument
Participants will receive vonaprument IVT injections every month during the 24-month treatment period.
干预措施: Vonaprument (Drug)
Sham Group
Participants will receive Sham IVT injections every month during the 24-month treatment period.
干预措施: Sham Administration (Other)
结局指标
主要结局
Proportion of patients experiencing a best corrected visual acuity (BCVA) ≥15-letter loss from baseline through the primary timepoint as assessed by the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at any two consecutive visits.
时间窗: The primary timepoint is based on accumulation of the target event rate, but no earlier than Month 12 and no later than Month 18
Proportion of Participants Experiencing a Best Corrected Visual Acuity (BCVA) ≥15-letter Loss from Baseline Through Month 15 as Assessed by the Early Treatment Diabetic Retinopathy Study (ETDRS) Chart at Any Two Consecutive Visits
时间窗: Baseline through Month 15
次要结局
- Change From Baseline in the Hazard of ≥15 letter BCVA Loss Through Month 12 and Month 24(Baseline, Months 12 and 24)
- Time to Confirmed BCVA ≥15-letter Loss(Baseline to Month 15 and Baseline to Month 24)
- Proportion of Participants Experiencing a Confirmed BCVA ≥15-letter Loss(Baseline through Month 24)
- Proportion of Participants with Low-luminance BCVA (LLVA) ≥15-letter Loss(Baseline through Month 15 and Baseline through Month 24)
- Change from Baseline in Area of Total Loss of the Ellipsoid Zone (EZ) Layer(Baseline, Month 15 and 24)