A Phase 2, Multicenter, Prospective, Double-masked, Parallel Study of EYP-1901, a Tyrosine Kinase Inhibitor (TKI), Compared to Sham for the Improvement of Moderately Severe to Severe Nonproliferative Diabetic Retinopathy (NPDR)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- Percentage of Subjects Improved >=2 Steps From Baseline in the DRSS Score at Week 36
研究概览
简要总结
A prospective, randomized, double-masked study that evaluated the ocular efficacy and safety of two doses of the EYP-1901 intravitreal (IVT) insert compared to sham.
详细描述
This study evaluated the ocular efficacy and safety of two doses of the EYP-1901 IVT insert compared to sham using a randomized double-masked trial design.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Participants must have a hemoglobin A1c <=12%
- •Study eye with moderately severe to severe Non proliferative Diabetic Retinopathy (NPDR) (based on the Diabetic Retinopathy Severity Scale (DRSS) levels 47 or 53)
- •Best corrected visual acuity (BCVA) using Early Treatment Diabetic Retinopathy Study (ETDRS) letter score in the study eye of >=69 letters (approximate Snellen equivalent of 20/40 or better).
排除标准
- •Presence of any active Center involved-diabetic macular edema in the study eye as determined by the Investigator on clinical examination, or within the central subfield thickness (CST) of the study eye, with a CST threshold greater than 320 microns.
- •Any evidence or documented history of prior focal or grid laser photocoagulation or any pan-retinal photocoagulation (PRP) in the study eye in the last 12 months.
研究组 & 干预措施
EYP-1901 2060 ug
EYP-1901 2060 ug; single injection
干预措施: EYP-1901 (Drug)
EYP-1901 3090 ug
EYP-1901 3090 ug; single injection
干预措施: EYP-1901 (Drug)
Sham IVT
Sham IVT; single injection
干预措施: Sham IVT (Other)
结局指标
主要结局
Percentage of Subjects Improved >=2 Steps From Baseline in the DRSS Score at Week 36
时间窗: Baseline (Day 1) and Week 36
The DRSS used to describe overall retinopathy severity as well as the change in severity over time in the study eye. Severity ranges from level 10 (diabetic retinopathy absent) to level 85 (advanced proliferative diabetic retinopathy (PDR): posterior fundus obscured, or center of macula detached). Here, DRSS describes severity level 47 (moderately severe NPDR) and level 53 (severe NPDR) at Week 36 from baseline.
次要结局
- Percentage of Subjects Improved >=2 Steps From Baseline in the DRSS Score at Week 24 and Week 48(Baseline (Day 1), Week 24, and Week 48)
- Percentage of Subjects Improved >=2 Steps and >=3 Steps From Baseline in DRSS Score at Weeks 24, 36 and 48(Baseline (Day 1) and Weeks 24, 36 and 48)
- Percentage of Subjects Worsened >=2 Steps and >=3 Steps From Baseline in DRSS Score at Weeks 24, 36 and 48(Baseline (Day 1) and Weeks 24, 36 and 48)
- Percentage of Subjects Who Developed a Vision-Threatening Complication Due to Diabetic Retinopathy at Weeks 24, 36 and 48(Weeks 24, 36 and 48)
- Percentage of Subjects Who Developed Center Involved-Diabetic Macular Edema (CI-DME) at Weeks 24, 36 and 48(Weeks 24, 36 and 48)
- Time to Develop Any Neovascular Vision Threatening Complication (PDR/ASNV) at Weeks 24, 36 and 48(Weeks 24, 36 and 48)
- Time to Develop CI-DME Through Weeks 24, 36 and 48(Weeks 24, 36 and 48)
- Percentage of Subjects Who Received Anti-Vascular Endothelial Growth Factor (VEGF) or Additional Standard of Care Intervention Due to Ocular Diabetic Complications at Weeks 24, 36 and 48(Weeks 24, 36 and 48)
- Percentage of Subjects Who Received PRP at Weeks 24, 36 and 48(Weeks 24, 36 and 48)
- Area Under the Curve (AUC) for Change From Baseline in BCVA at Weeks 24, 36 and 48(Weeks 24, 36 and 48)
- Plasma Concentration of EYP-1901 and X-297 at Weeks 24, 36 and 48(Weeks 24, 36 and 48)
- Number of Subjects With Ocular and Non-Ocular TEAEs and Serious TEAEs up to Week 48(TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.)