NCT07807969尚未招募3 期
A Multicenter, Open-Label Extension Study of the Long-Term Safety of Vonaprument (ANX007) Administered by Intravitreal Injection in Participants With Dry Age-Related Macular Degeneration With Geographic Atrophy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 605
- 试验地点
- 7
- 主要终点
- Number of Participants with Treatment Emergent Adverse Events
研究概览
简要总结
The primary purpose of the study is to assess the long term safety of intravitreal (IVT) injections of vonaprument.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 with a diagnosis of dry AMD with GA who completed the Phase 3 ARCHER II study (NCT06510816) and who had not permanently ceased receiving the assigned masked treatment (IVT or Sham administration) at/before the ARCHER II Month 24 Visit.
排除标准
- •Any event or condition arising during the ARCHER II study that would put the participant in danger or lead to undue harm by participating in this OLE study.
研究组 & 干预措施
Vonaprument
Experimental
Participants will receive vonaprument IVT injections every month for 24 months.
干预措施: Vonaprument (Drug)
结局指标
主要结局
Number of Participants with Treatment Emergent Adverse Events
时间窗: Through Month 24
次要结局
未报告次要终点
研究者
研究点 (7)
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