A Phase 2, Randomized, Double-Masked, Controlled Trial to Establish the Safety and Efficacy of Intravitreous Injections of E10030 (Anti-PDGF Pegylated Aptamer) Given in Combination With Lucentis in Subjects With Neovascular Age-Related Macular Degeneration
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 449
- 试验地点
- 1
- 主要终点
- Mean Change in Visual Acuity From Baseline at the Week 24 Visit
研究概览
简要总结
The objectives of this study are to evaluate the safety and efficacy of E10030 intravitreous injection when administered in combination with Lucentis® against a control of Lucentis® alone in subjects with subfoveal choroidal neovascularization secondary to age-related macular degeneration (AMD).
详细描述
Subjects will be randomized in a 1:1:1 ratio to the following dose groups:
- E10030 0.3 mg/eye + Lucentis® 0. 5 mg/eye
- E10030 1.5 mg/eye + Lucentis® 0. 5 mg/eye
- E10030 sham + Lucentis® 0. 5 mg/eye
Subjects will be treated with active E10030 or sham E10030 in combination with Lucentis® at Day 0, Week 4, Week 8, Week 12, Week 16 and Week 20.
Primary Efficacy Endpoint:
The primary efficacy endpoint is mean change in visual acuity from baseline at the Week 24 visit
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
- 50 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subfoveal choroidal neovascularization (CNV) due to AMD
排除标准
- •Any of the following underlying diseases including:
- •Diabetes mellitus
- •History or evidence of severe cardiac disease (e.g., NYHA Functional Class III or IV - see Appendix 19.6), history or clinical evidence of unstable angina, acute coronary syndrome, myocardial infarction or coronary artery revascularization within 6 months, or ventricular tachyarrhythmias requiring ongoing treatment.
- •Clinically significant impaired renal or hepatic function.
- •Stroke (within 12 months of trial entry).
- •Any major surgical procedure within one month of trial entry.
- •Known serious allergies to the fluorescein dye used in angiography (mild allergy amenable to treatment is allowable), to the components of the ranibizumab (Lucentis) formulation, or to the components of the E10030 formulation
研究组 & 干预措施
Lucentis
干预措施: Lucentis (Drug)
E10030 low dose plus Lucentis
干预措施: E10030 plus Lucentis (Drug)
E10030 high dose plus Lucentis
干预措施: E10030 plus Lucentis (Drug)
结局指标
主要结局
Mean Change in Visual Acuity From Baseline at the Week 24 Visit
时间窗: 24 Weeks
The primary efficacy endpoint is the mean change in visual acuity from baseline at the Week 24 visit
次要结局
- Proportion of Patients With at Least 1 Adverse Event(24 weeks)
- The Proportion of Subjects Gaining 15 or More ETDRS Letters From Baseline at the Week 24 Visit(24 weeks)