A Phase 3 Randomized, Double-masked, Controlled Trial to Establish the Safety and Efficacy of Intravitreous Administration of Fovista® (Anti PDGF-B Pegylated Aptamer) Administered in Combination With Either Avastin® or Eylea® Compared to Avastin® or Eylea® Monotherapy in Subjects With Subfoveal Neovascular Age-related Macular Degeneration.
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 645
- 主要终点
- Mean Change in Visual Acuity (Measured at Baseline and at the Month 12 Visit)
研究概览
简要总结
The objectives of this study are to evaluate the safety and efficacy of intravitreal administration of Fovista® administered in combination with either Avastin® or Eylea® compared to Avastin® or Eylea® monotherapy 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 ratio to the following two arms per study design:
- Fovista® 1.5 mg/eye + Avastin® 1.25 mg/eye or Eylea® 2 mg/eye
- Fovista® sham + Avastin® 1.25 mg/eye or Eylea® 2 mg/eye
Subjects will be treated for up to 24 months with active Fovista® or sham, in combination with either Avastin® or Eylea® with the primary endpoint at 12 months.
Approximately 622 subjects will be randomized into one of the two treatment groups (311 patients per dose group), and the efficacy analysis will be based on the data from these two groups as per the SAP
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects of either gender aged ≥ 50 years
- •Active subfoveal choroidal neovascularization (CNV) secondary to AMD
- •Presence of sub-retinal hyper-reflective material (SD-OCT)
排除标准
- •Any prior treatment for AMD in the study eye prior to the Day 1 visit, except oral supplements of vitamins and minerals
- •Any prior intravitreal treatment in the study eye prior to the Day 1 visit, regardless of indication (including intravitreal corticosteroids)
- •Any intraocular surgery or thermal laser within three (3) months of trial entry. Any prior thermal laser in the macular region, regardless of indication
- •Subjects with subfoveal scar or subfoveal atrophy are excluded
- •Diabetes mellitus
研究组 & 干预措施
E10030 + bevacizumab or aflibercept
E10030 1.5 mg intravitreal injection + bevacizumab 1.25 mg intravitreal injection or aflibercept 2 mg intravitreal injection
干预措施: bevacizumab or aflibercept (Drug)
E10030 + bevacizumab or aflibercept
E10030 1.5 mg intravitreal injection + bevacizumab 1.25 mg intravitreal injection or aflibercept 2 mg intravitreal injection
干预措施: E10030 (Drug)
Sham + bevacizumab or aflibercept
E10030 sham injection + bevacizumab 1.25 mg intravitreal injection or aflibercept 2 mg intravitreal injection
干预措施: bevacizumab or aflibercept (Drug)
Sham + bevacizumab or aflibercept
E10030 sham injection + bevacizumab 1.25 mg intravitreal injection or aflibercept 2 mg intravitreal injection
干预措施: E10030 sham injection (Drug)
结局指标
主要结局
Mean Change in Visual Acuity (Measured at Baseline and at the Month 12 Visit)
时间窗: 12 months
The primary efficacy endpoint is the mean change in visual acuity (ETDRS letters) measured at baseline and at the month 12 visit. Higher ETDRS letters represents higher vision and a higher change in ETDRS letters represents better functioning.
次要结局
未报告次要终点