jRCT2041210008已完成不适用
A Phase III Randomized, Double-Masked, Parallel Group, Multicenter Study to Compare the Efficacy, Safety, Tolerability, Pharmacokinetics, and Immunogenicity between SCD411 and Eylea in Subjects with Neovascular Age-related Macular Degeneration
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 主要终点
- best corrected visual acuity (BCVA)
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 50age old over 至 No limit（—）
- 性别
- All
入选标准
- •Age >=50 years.
- •Active choroidal subfoveal, juxtafoveal, or extrafoveal neovascularization lesions secondary to AMD evidenced by fluorescein angiography (FA) in the study eye at screening and confirmed by the central reading center.
排除标准
- •Any prior ocular (in the study eye and fellow eye) or systemic treatment or surgery for neovascular AMD except dietary supplements or vitamins
- •Any prior or concomitant therapy with another investigational agent to treat neovascular AMD in the study eye, except dietary supplements or vitamins
结局指标
主要结局
best corrected visual acuity (BCVA)
时间窗: after 8 weeks of treatment
To prove the equivalence of SCD411 as compared to Eylea (aflibercept)
次要结局
- Safety and tolerability
- Efficacy (BCVA, CRT, CNV)(8 weeks and 52 weeks of treatment)
- Immunogenicity
研究者
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