NCT06491914进行中（未招募）3 期
A Phase 3b Single-Arm Study of Aflibercept 8 mg in Participants With Neovascular Age-Related Macular Degeneration (nAMD) or Diabetic Macular Edema (DME)
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,118
- 试验地点
- 51
- 主要终点
- Occurrence of serious TEAEs
研究概览
简要总结
This study is researching aflibercept high dose (HD), referred to as "study drug", with an experimental dosing regimen. The study is focused on participants with nAMD and DME that have been previously treated with anti-vascular endothelial growth factor (anti-VEGF) medications.
The aim of the study is to see how safe and effective aflibercept HD injections are when given as frequently as every 4 weeks. The study is also looking at what side effects may happen from taking the study drug.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Aflibercept 8 mg
Experimental
Participants previously treated with anti-vascular endothelial growth factor (anti-VEGF) medications
干预措施: Aflibercept 8 mg (Drug)
结局指标
主要结局
Occurrence of serious TEAEs
时间窗: Through week 24
Occurrence of treatment-emergent adverse events (TEAEs)
时间窗: Through week 24
次要结局
未报告次要终点
研究者
研究点 (51)
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