NCT04820452已完成2 期
A Multi-center, Randomized, Double-blind, Active-controlled Phase II Study to Evaluate the Efficacy and Safety of IBI302 in Subjects With Neovascular Age-related Macular Degeneration
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 231
- 试验地点
- 1
- 主要终点
- The visual efficacy of IBI302
研究概览
简要总结
This is a multi-center, randomized, double-blind, active-controlled study to evaluate the efficacy and safety of IBI302 in subjects with neovascular age-related macular degeneration.
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
- Single (Participant)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
cohort 1 IBI302 treated with high dose level of IBI302
Experimental
Drug: IBI302 4mg/eye;Intraocular injection
干预措施: High dose IBI302 (Biological)
Aflibercept
Active Comparator
Drug: Aflibercept 2mg/eye;Intraocular injection
干预措施: Aflibercept (Drug)
cohort 1 IBI302 treated with low dose level of IBI302
Experimental
Drug: IBI302 2mg/eye;Intraocular injection
干预措施: Low dose IBI302 (Biological)
结局指标
主要结局
The visual efficacy of IBI302
时间窗: Baseline to week 36
次要结局
- the anatomical effects of IBI302 on FFA(Baseline to week 52)
- the safety of IBI302(Baseline to week 52)
- other visual effects of IBI302(Baseline to week 52)
- the anatomical effects of IBI302 on OCT(Baseline to week 52)
- Immunogenicity of IBI302(Baseline to week 52)
研究者
研究点 (1)
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