A Phase 2a Study to Establish the Safety and Tolerability of Zimura™ (Anti-C5 Aptamer) in Combination With Anti-VEGF Therapy in Subjects With Idiopathic Polypoidal Choroidal Vasculopathy (IPCV)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 4
- 主要终点
- Number of Participants With >15 ETDRS Letter Loss at Month 3
研究概览
简要总结
The objectives of this study are to evaluate the safety and tolerability of Zimura™ intravitreous injection in combination with anti-vascular endothelial growth factor (VEGF) therapy in subjects with Idiopathic Polypoidal Choroidal Vasculopathy (IPCV).
详细描述
Treatment experienced (Prior treatment with anti-VEGF monotherapy of ≥8 injections in the previous twelve (12) months) subjects of either gender aged 50 years or above with a diagnosis of IPCV, will receive 3 monthly (Q4W) intravitreal injections of Zimura™ (1 mg/eye) in combination with anti-VEGF therapy (Avastin® 1.25 mg/eye or Lucentis® 0.5 mg/eye or Eylea® 2 mg/eye).
Safety endpoints include visual acuity loss (proportion of subjects with >15 letter loss at Month 3), ophthalmic adverse events (AEs), systemic adverse events (AEs), change in total retinal thickness (SD-OCT) at Month 3, regression and/or elimination of polyps at Month 3 compared to screening as measured by indocyanine green angiography (ICGA), and laboratory values.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Diagnosis of IPCV
- •Treatment-experienced defined as prior treatment with anti-VEGF mono therapy of ≥ 8 injections in the previous twelve (12) months
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
- •Any ocular or periocular infection in the twelve (12) weeks prior to entry
- •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
- •Previous therapeutic radiation in the region of the study eye
- •A diagnosis of diabetic retinopathy (presence of microaneurysms or any vasculopathy and/or leakage from retinal vasculature in a subject with diabetes mellitus)
研究组 & 干预措施
Avacincaptad Pegol + Anti-VEGF
Subjects will receive monthly intravitreous injections of Avacincaptad Pegol in combination with either Lucentis, Avastin or Eylea.
干预措施: Avacincaptad Pegol (Drug)
结局指标
主要结局
Number of Participants With >15 ETDRS Letter Loss at Month 3
时间窗: 3 Months
Number of participants with \>15 ETDRS letter loss (with calculated percentage)
Number of Participants With Ophthalmic Adverse Events
时间窗: 3 months
Number of Participants with Ophthalmic Adverse Events (with calculated percentage)
Number of Participants With Systemic Adverse Events
时间窗: 3 months
Number of Participants with Systemic Adverse Events (with calculated percentage)
次要结局
未报告次要终点