Phase 1b/2a Study of OPT-302 in Combination With Aflibercept for Persistent Central-involved Diabetic Macular Edema
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 153
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
研究概览
简要总结
A two part, multi-center study consisting of a Phase 1b open label, sequential dose escalation followed by a Phase 2a randomized, double-masked, dose expansion evaluating OPT-302 in combination with aflibercept in participants with persistent central-involved Diabetic Macular Edema.
详细描述
Study OPT-302-1003 was designed as a 2-part, multicenter study consisting of a Phase 1b open-label, sequential dose escalation followed by a Phase 2a randomized, parallel-group, sham-controlled, double-masked, dose-expansion evaluating intravitreal OPT-302 in combination with aflibercept in participants with persistent central-involved diabetic macula edema.
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)
盲法说明
Ph 1b open label; Ph 2a quadruple masked
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
- •History of diabetic macular edema (DME) ≤ 2 year
- •Persistent DME despite prior intravitreal anti-VEGF-A therapy with a sub-optimal response
- •Three or more prior anti-VEGF-A therapy intravitreal injections
- •EDTRS BCVA score ≤ 73 and ≥ 24 letters
排除标准
- •Ocular disorders or ocular treatments which may interfere with assessment of visual acuity, assessment of toxicity, or fundus photography in the Study Eye
- •HbA1c ≥ 12% and/or recent signs of uncontrolled diabetes
- •Any clinically significant disorder or condition or disease (e.g. cardiovascular, renal conditions) that would make the participant unsuitable for the study
研究组 & 干预措施
Ph 1b: 2.0 mg aflibercept with 0.3 mg OPT-302
2.0 mg aflibercept intravitreal injection (0.05 mL) followed by 0.3 mg OPT-302 intravitreal injection (0.05 mL)
干预措施: OPT-302 (Biological)
Ph 1b: 2.0 mg aflibercept with 0.3 mg OPT-302
2.0 mg aflibercept intravitreal injection (0.05 mL) followed by 0.3 mg OPT-302 intravitreal injection (0.05 mL)
干预措施: Aflibercept (Biological)
Ph 1b: 2.0 mg aflibercept with 1.0 mg OPT-302
2.0 mg aflibercept intravitreal injection (0.05 mL) followed by 1.0 mg OPT-302 intravitreal injection (0.05 mL)
干预措施: Aflibercept (Biological)
Ph 1b: 2.0 mg aflibercept with 1.0 mg OPT-302
2.0 mg aflibercept intravitreal injection (0.05 mL) followed by 1.0 mg OPT-302 intravitreal injection (0.05 mL)
干预措施: OPT-302 (Biological)
Ph 1b: 2.0 mg aflibercept with 2.0 mg OPT-302
2.0 mg aflibercept intravitreal injection (0.05 mL) followed by 2.0 mg OPT-302 intravitreal injection (0.05 mL)
干预措施: Aflibercept (Biological)
Ph 1b: 2.0 mg aflibercept with 2.0 mg OPT-302
2.0 mg aflibercept intravitreal injection (0.05 mL) followed by 2.0 mg OPT-302 intravitreal injection (0.05 mL)
干预措施: OPT-302 (Biological)
Ph 2a: 2.0 mg aflibercept with 2.0 mg OPT-302
2.0 mg aflibercept intravitreal injection (0.05 mL) followed by 2.0 mg OPT-302 intravitreal injection (0.05 mL)
干预措施: Aflibercept (Biological)
Ph 2a: 2.0 mg aflibercept with 2.0 mg OPT-302
2.0 mg aflibercept intravitreal injection (0.05 mL) followed by 2.0 mg OPT-302 intravitreal injection (0.05 mL)
干预措施: OPT-302 (Biological)
Ph 2a: 2.0 mg aflibercept with sham
2.0 mg aflibercept intravitreal injection (0.05 mL) followed by sham intravitreal injection
干预措施: Aflibercept (Biological)
Ph 2a: 2.0 mg aflibercept with sham
2.0 mg aflibercept intravitreal injection (0.05 mL) followed by sham intravitreal injection
干预措施: Sham intravitreal injection (Other)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
时间窗: Baseline to Week 12
Safety and Tolerability will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events and CTC v4.0 (if available, otherwise protocol defined grading were used)
Phase 2a: Response Rate Defined as Proportion of Participants Receiving OPT-302 With Aflibercept Achieving at Least a 5-letter Gain in BCVA at Week 12
时间窗: Baseline to Week 12
Change from baseline in Best Corrected Visual Acuity (BCVA) will be measured at Week 12 according to Early Treatment Diabetic Retinopathy Score (ETDRS) criteria
次要结局
- Mean Change in CST(Baseline to Week 12)
- Mean Change in BCVA(Baseline to Week 12)