A Randomized, Double-masked, Active-controlled, Multi-center, Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal Tabirafusp Tedromer 5 mg Compared With Intravitreal Aflibercept 2 mg in Participants With Visual Impairment Secondary to Diabetic Macular Edema (DME) - ALTO
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 910
- 试验地点
- 9
- 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 Tabirafusp Tedromer Compared to Aflibercept in Participants with Diabetic Macular Edema - ALTO
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DME, treatment-naïve or previously-treated
- •Male or female ≥18 years of age with Type 1 or Type 2 diabetes mellitus and a HbA1c of ≤12%
- •Capable of giving informed signed consent
排除标准
- •Active iris or angle neovascularization or neovascular glaucoma in the Study Eye.
- •Current or history of retinal detachment (tractional or rhegmatogenous) in the Study Eye
研究组 & 干预措施
Tabirafusp tedromer 5 mg Q8W
Intravitreal injection of tabirafusp tedromer once every 4 weeks for 6 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 5 monthly doses followed by every-8-week dosing
干预措施: Aflibercept (2.0 mg) (Drug)
Tabirafusp tedromer 5 mg Q4-24W
Intravitreal injection of tabirafusp tedromer once every 4 weeks for 6 monthly doses followed by individualized dosing every 4 to 24 weeks.
干预措施: Tabirafusp tedromer (Drug)
结局指标
主要结局
Best corrected visual acuity (BCVA)
时间窗: Week 52
Mean change in BCVA from Day 1 to Year 1
次要结局
未报告次要终点