NCT07449923进行中（未招募）3 期
A Phase 3, Multicenter, Prospective, Randomized, Double-Masked, Parallel-Group Study of EYP-1901, a Tyrosine Kinase Inhibitor (TKI), Compared to Aflibercept (2 mg) in Participants With Diabetic Macular Edema (DME)
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 240
- 试验地点
- 140
- 主要终点
- Average change in best corrected visual acuity (BCVA)
研究概览
简要总结
This is a phase 3 randomized, double -masked study comparing the efficacy of EYP-1901 against Aflibercept.
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
- •Previously treated or treatment naïve patients with a documented diagnosis of macular edema associated with diabetic retinopathy (DR) in the study eye, with onset of disease that began at any time prior to the Screening Visit.
- •Best-corrected visual acuity (BCVA) Early Treatment Diabetic Retinopathy Study (ETDRS) letter score of 35 letters (20/200 Snellen equivalent) to 78 letters (20/32 Snellen equivalent) in the study eye at the Screening Visit and at Baseline (Day 1).
- •For previously treated participants: at least 1 injection of anti-VEGF in the past 12 months, the most recent anti-VEGF treatment for DME must not have been administered less than 12 weeks prior to the Screening Visit.
排除标准
- •BCVA using ETDRS charts <30 letters (20/250 Snellen equivalent) in the fellow eye.
研究组 & 干预措施
Aflibercept
Active Comparator
干预措施: Aflibercept (2.0 mg) (Drug)
EYP-1901 2686 µg
Experimental
EYP-1901
干预措施: EYP-1901 (Drug)
结局指标
主要结局
Average change in best corrected visual acuity (BCVA)
时间窗: Weeks 52 and 56
BCVA Early Treatment Diabetic Retinopathy Study (ETDRS) letter score change from Baseline to the average of Weeks 52 and 56
次要结局
- Rate of injection burden(Week 56)
研究者
研究点 (140)
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