A 24 Month Phase 2A Open Label Safety Study of Fovista® (Anti-PDGF-BB Pegylated Aptamer) Regiment Administered in Combination With Avastin®, Eylea®, or Lucentis®) During the Induction and Maintenance Phase of Therapy
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 101
- 主要终点
- Number of Subject With Non Serious Adverse Events (Reported by >5% of Subjects)
研究概览
简要总结
The objective is to evaluate the safety of intravitreal Fovista® (anti-PDGF BB) administered in combination with anti-VEGF therapy.
详细描述
The objective is to evaluate the safety of intravitreal Fovista® (anti-PDGF BB) administered in combination with anti-VEGF therapy in either a "Simultaneous" Regimen (Fovista® administered with anti-VEGF same day) or "Pre-Treatment" Regimen (monotherapy Fovista® Day 0 followed by Fovista® administered in combination with anti-VEGF Day 2).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •All fluorescein angiographic subtypes with presence of active choroidal neovascularization
排除标准
- •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
- •Any ocular or periocular infection in the past twelve (12) weeks
- •History of any of the following conditions or procedures in the study eye: Rhegmatogenous retinal detachment, pars plana vitrectomy, filtering surgery (e.g. trabeculectomy), glaucoma drainage device, corneal transplant
研究组 & 干预措施
Fovista® plus anti-VEGF Simultaneous
Subjects will be administered Fovista® (anti-PDGF BB) plus anti-VEGF as a "Simultaneous" regimen followed by quarterly administration.
干预措施: Fovista® (anti-PDGF BB) plus anti-VEGF (Drug)
Fovista® plus anti-VEGF Pre-Treatment
Subjects will be administered Fovista® (anti-PDGF BB) plus anti-VEGF as a "Pre-Treatment" regimen followed by quarterly administration.
干预措施: Fovista® (anti-PDGF BB) plus anti-VEGF (Drug)
结局指标
主要结局
Number of Subject With Non Serious Adverse Events (Reported by >5% of Subjects)
时间窗: 2 years
Number of subjects on either arm with non-serious adverse events (reported by \>5% of subjects)
Number of Subjects With Serious Adverse Events
时间窗: 2 years
Number of subjects with serious adverse events in each arm
次要结局
未报告次要终点