NCT06495918进行中（未招募）3 期
A Phase 3, Multicenter, Double-Masked, Randomized, Parallel Group Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Axitinib Implant) in Subjects With Neovascular Age- Related Macular Degeneration
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
- 825
- 试验地点
- 88
- 主要终点
- Best Corrected Visual Acuity (BCVA)
研究概览
简要总结
Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Axitinib Implant) 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
- 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
- •Treatment naïve juxtafoveal and/or SFNV secondary to Neovascular Age- Related Macular Degeneration (nAMD) with leakage involving the fovea in the study eye prior to Screening, or have a diagnosis of Neovascular Age- Related Macular Degeneration (nAMD) in study eye within 3 months prior to screening and received up to 2 monthly injections of 2 mg aflibercept with last injection approximately 4 weeks prior to Screening
- •Have provided written consent
排除标准
- •Monocular subject or Best Corrected Visual Acuity (BCVA) score of <20 ETDRS letters or 20/400 in fellow eye at Screening
- •Have evidence of a scar, fibrosis, or atrophy of >50% of the total lesion in the study eye.
研究组 & 干预措施
OTX-TKI Re-dose
Experimental
干预措施: OTX-TKI (Drug)
Aflibercept 2mg on label
Active Comparator
干预措施: Aflibercept (Drug)
Aflibercept 8mg high dose
Other
干预措施: Aflibercept (Drug)
结局指标
主要结局
Best Corrected Visual Acuity (BCVA)
时间窗: Week 48
Mean change in Best Corrected Visual Acuity (BCVA) from baseline at Week 48
次要结局
未报告次要终点
研究者
研究点 (88)
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