A Prospective, Randomized, Double-masked, Active Comparator-controlled, Multi-center, Three-arm Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal Tarcocimab Tedromer and Tabirafusp Tedromer Compared With Intravitreal Aflibercept in Participants With Neovascular (Wet) Age-related Macular Degeneration (wAMD)
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 675
- 试验地点
- 129
- 主要终点
- Best corrected visual acuity (BCVA)
研究概览
简要总结
A Study to Evaluate the Efficacy and Safety of Tarcocimab Tedromer and Tabirafusp Tedromer Compared to Aflibercept in Participants with Neovascular (Wet) Age-related Macular Degeneration (wAMD)
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
- •Active, treatment-naïve choroidal neovascularization (CNV) secondary to AMD, including subfoveal, juxtafoveal, and extrafoveal lesions, or retinal angiomatous proliferations (RAP) lesions with a CNV component that affects the central subfield, as evidenced by FA or OCT in the Study Eye at Screening
- •BCVA ETDRS score between 78 and 25 letters (Snellen equivalent ~20/32 and 20/320) inclusive, in the Study Eye at screening and reconfirmed at Day
- •Capable of giving signed informed consent.
排除标准
- •BCVA of hand motion or worse in the non-Study Eye or non-physical presence of a non-Study Eye (i.e., monocular)
- •Fibrosis or atrophy of >50% of the lesion size and/or involving the foveal center of the Study Eye at Screening
研究组 & 干预措施
Tarcocimab tedromer 5 mg (KSI-301)
Intravitreal injection of tarcocimab tedromer once every 4 weeks for 4 monthly doses followed by individualized dosing every 4 to 24 weeks.
干预措施: Tarcocimab tedromer (Drug)
Tabirafusp tedromer 5 mg (KSI-501)
Intravitreal injection of tabirafusp tedromer once every 4 weeks for 4 monthly doses followed by every-8-week dosing with additional individualized dosing (up to monthly dosing)
干预措施: Tabirafusp tedromer (Drug)
Aflibercept 2 mg
Intravitreal injection of aflibercept once every 4 weeks for 3 monthly doses followed by every-8-week dosing
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 BCVA from Day 1 to Year 1
次要结局
未报告次要终点