NCT05155293进行中（未招募）3 期
A Randomized, Double-masked, Parallel-group, Multicenter Clinical Study to Evaluate the Efficacy and Safety of AVT06 Compared With EU-Eylea® in Subjects With Neovascular (Wet) Age-related Macular Degeneration (ALVOEYE)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 413
- 试验地点
- 6
- 主要终点
- Change from baseline to Week 8 in Best-corrected Visual Acuity (BCVA)
研究概览
简要总结
This is a randomized, double-masked, parallel-group, multicenter, therapeutic equivalence study evaluating the efficacy, safety, and immunogenicity of AVT06 compared with Eylea in subjects with neovascular (wet) AMD.
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
- •Subject must be ≥50 years of age, at the time of signing the informed consent.
- •Subjects must be diagnosed with neovascular (wet) AMD in the study eye.
- •Subjects must have active, treatment naïve, subfoveal CNV lesions secondary to neovascular (wet) AMD.
- •Willingness and ability to undertake all scheduled visits and assessments.
排除标准
- •Any prior systemic treatment with anti-VEGF therapy
- •Any condition that, in the Investigator ́s opinion, can interfere with full participation in the study, including administration of the study treatment and attending required visits; can pose a significant risk to the participant, or interfere with interpretation of study data
- •Prior treatment with any investigational drugs within 30 days or 5 half-lives (whichever is longer) of the previous investigational treatment before initiation of the study treatment or concomitant enrollment in any other clinical study involving an investigational study treatment
- •Subjects not suitable for participation, whatever the reason, as judged by the Investigator, including medical or psychiatric conditions, or participants potentially at risk of noncompliance to study procedures.
研究组 & 干预措施
AVT06 (proposed aflibercept biosimilar)
Experimental
Patients will receive 1 IVT injection of AVT06 every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion.
干预措施: AVT06 (proposed aflibercept biosimilar) (Drug)
Eylea® (Aflibercept)
Experimental
Patients will receive 1 IVT injection of Eylea® every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion.
干预措施: Eylea® (Aflibercept) (Drug)
结局指标
主要结局
Change from baseline to Week 8 in Best-corrected Visual Acuity (BCVA)
时间窗: Week 8
次要结局
未报告次要终点
研究者
研究点 (6)
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