NCT02860858已完成4 期
Intravitreal Aflibercept for Treatment of Polypoidal Choroidal Vasculopathy (PCV)
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Best corrected visual acuity (BCVA)
研究概览
简要总结
Objective: To evaluate the efficacy of intravitreal aflibercept injection on visual acuity in patients with symptomatic macular PCV.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or Female >/= 18 years
- •Confirmed diagnosis of symptomatic macular PCV in the study eye defined by: - Active macular polypoidal lesions shown by ICGA and - Presence of serosanguinous maculopathy
- •BCVA letter score between 78-24 using ETDRS visual acuity chart measured at 4 meters
排除标准
- •Previous treatment with systemic anti-VEGF drugs within 6 months prior to Baseline (e.g., sorafenib [Nexavar®], sunitinib [Sutent®], bevacizumab [Avastin®])
- •Active ocular inflammation or infection (ocular or periocular)
- •Uncontrolled intraocular hypertension or glaucoma (IOP> 30 mmPIg) despite treatment with anti-glaucoma medication
- •Predominantly-scarred PCV lesions
- •Ocular disorders in the study eye (e.g. cataract, retinal vascular occlusion, diabetic retinopathy) that, in the opinion of the investigator may confound interpretation of study results or compromise VA or require medical or surgical intervention during the study period
- •Prior treatment with verteporfin PDT, external-beam radiation, subfoveal or extrafoveal focal laser photocoagulation, submacular surgery, or transpupillary thermotherapy
- •Prior treatment with any anti-VEGF compound or any investigational treatment
- •Treatment with intravitreal or subtenon corticosteroid injection or device implantation within 90 days
结局指标
主要结局
Best corrected visual acuity (BCVA)
时间窗: 2 years
次要结局
未报告次要终点
研究者
研究点 (2)
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