NCT06099184已完成2 期
A Phase 2, Multicenter, Prospective, Randomized, Double-Masked, Parallel Study of EYP-1901, a Tyrosine Kinase Inhibitor (TKI), Compared to Aflibercept in Subjects With Diabetic Macular Edema (DME)
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Time to first supplemental aflibercept injection following EYP-1901 dose at Baseline vs Aflibercept
研究概览
简要总结
A prospective, randomized, single-masked study evaluating the ocular efficacy and safety of two doses of the EYP-1901 intravitreal insert compared to aflibercept
详细描述
A study to evaluate Efficacy and Safety of two doses of EYP-1901 in subjects with DME
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
- Single (Participant)
盲法说明
Single (Participant)
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
- •Diagnosis of diabetes mellitus in the study eye, with disease onset any time prior to the Screening Visit
- •Previously treated with at least 1 intravitreal anti-VEGF in the last 6 months in the study eye at least 8 weeks prior to the Screening Visit.
- •BCVA letter score of 35 letters (20/200 Snellen equivalent) to 75 letters (20/32 Snellen equivalent) in the study eye at the Screening Visit and at Baseline (Day 1).
排除标准
- •Any current or history of ocular disease other than DME
- •BCVA using ETDRS charts <30 letters (20/250 Snellen equivalent) in the fellow eye.
- •Active ocular inflammation or active infection in either eye at Baseline (Day 1).
研究组 & 干预措施
EYP-1901 1343 µg
Experimental
EYP-1901 1343 µg, single dose
干预措施: EYP-1901 (Drug)
EYP-1901 2686 µg
Experimental
EYP-1901 2686 µg, single dose
干预措施: EYP-1901 (Drug)
Aflibercept
Active Comparator
Aflibercept 2 mg/0.05mL solution, single dose
干预措施: Aflibercept 2Mg/0.05Ml Inj,Oph (Drug)
结局指标
主要结局
Time to first supplemental aflibercept injection following EYP-1901 dose at Baseline vs Aflibercept
时间窗: Week 24
Timing of supplemental injection
次要结局
- Change in best corrected visual acuity (BCVA)(Week 24)
研究者
研究点 (1)
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相关资讯
EyePoint's Duravyu Shows Promise in Phase 2 Trial for Diabetic Macular Edema- EyePoint Pharmaceuticals' Duravyu demonstrated significant improvement in visual acuity and retinal thickness in patients with diabetic macular edema (DME).
- The Phase 2 VERONA trial showed Duravyu 2.7mg led to an 8.9-letter improvement in BCVA compared to a 3.2-letter improvement with aflibercept at 16 weeks.
- Duravyu exhibited a favorable safety profile with no Duravyu-related serious adverse events and a reduced need for supplemental aflibercept injections.
- These results support Duravyu's potential as a sustained-release therapy for DME, offering a less burdensome treatment option for patients.last yearEyePoint's Duravyu Shows Promise in Phase 2 Trial for Diabetic Macular Edema- EyePoint Pharmaceuticals' Duravyu demonstrated early and sustained improvement in visual acuity and anatomical control in DME patients compared to aflibercept.
- The VERONA trial's 16-week interim results showed an 8.9-letter improvement in BCVA with Duravyu 2.7mg versus 3.2 letters with aflibercept.
- Duravyu exhibited a favorable safety profile with no Duravyu-related serious adverse events and a higher percentage of supplement-free eyes at 16 weeks.
- These results support Duravyu's potential as a durable treatment option for DME, with pivotal trials underway for wet AMD as well.last year