NCT03374670撤回2 期
A Phase 2A Open-Label Trial to Assess the Safety of ZIMURA™ (Anti-C5) in Combination With EYLEA® in Treatment Experienced Subjects With Idiopathic Polypoidal Choroidal Vasculopathy
Ophthotech Corporation1 个研究点 分布在 1 个国家开始时间: 2018年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Adverse Events (AEs)
研究概览
简要总结
To asses the safety of intravitreal Zimura™ (complement factor C5 inhibitor) administered in combination with Eylea® in treatment experienced subjects with idiopathic polypoidal choroidal vasculopathy
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
- 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
- •Diagnosis of IPCV
- •Patients must have had 3 sequential Eylea injections within the previous 4 months
排除标准
- •Intravitreal treatment in the study eye prior to screening, regardless of indication, except 3 prior injections of Eylea
- •History or evidence of severe cardiac disease
- •Any major surgical procedure within one month of trial entry
- •Subjects with a clinically significant laboratory value
- •Any treatment with an investigational agent in the past 60 days for any condition
- •Women who are pregnant or nursing
- •Known serious allergies to the fluorescein dye, ICG dye, iodine, povidone iodine, or to the components or formulation of either Zimura or Eylea
研究组 & 干预措施
Cohort 1
Experimental
Zimura dosage 1 + Eylea 2 mg
干预措施: Zimura (Drug)
Cohort 1
Experimental
Zimura dosage 1 + Eylea 2 mg
干预措施: Eylea (Drug)
Cohort 2
Experimental
Zimura dosage 2 + Eylea 2 mg
干预措施: Zimura (Drug)
Cohort 2
Experimental
Zimura dosage 2 + Eylea 2 mg
干预措施: Eylea (Drug)
结局指标
主要结局
Adverse Events (AEs)
时间窗: 9 months
AEs
次要结局
未报告次要终点
研究者
研究点 (1)
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