NCT02381730已完成不适用
Assessment of Visual Acuity in Patients With Polypoidal Choroidal Vasculopathy and Aflibercept Treatment
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 3
- 主要终点
- Evolution of the best corrected visual acuity (BCVA) measured on the EDTRS scale, between pre-injection and 28 weeks after injection
研究概览
简要总结
Polypoidal choroidal vasculopathy (PCV) is a disease of the choroidal vasculature, that is often regarded as a sub-type of age-related macular degeneration (AMD). However, PCV response to anti-vascular agents differs from the response of typical AMD.
This study aims at describing the evolution of the best corrected visual acuity (BCVA) in PCV patients, 28 weeks after they receive one injection of intravitreal aflibercept (2mg).
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
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Active polypoidal choroidal vasculopathy,
- •Visual acuity superior to 1/10 (20/200) and inferior to 6,25/10 (20/32)
- •Age above 45
- •No prior intravitreal treatment, or no response to prior treatment by 3 injections of ranibizumab, or disease recurrence after more than 3 months of stability
- •Intravitreal injection of aflibercept is indicated by current clinical recommendations
排除标准
- •Simultaneous treatment with another anti-VEGM agent
- •Diabetic retinopathy
- •Personal history of vitrectomy or uveitis
- •Personal history laser photocoagulation and/or verteporphin phototherapy
- •Tear in the pigmentary epithelium
- •Chorioretinitis scar
- •Macular atrophy in the pigmentary epithelium
- •Treatment with corticosteroids
- •Eye surgery less than 3 months before inclusion
研究组 & 干预措施
Aflibercept
Experimental
干预措施: Intravitreal aflibercept (Drug)
结局指标
主要结局
Evolution of the best corrected visual acuity (BCVA) measured on the EDTRS scale, between pre-injection and 28 weeks after injection
时间窗: 28 weeks
次要结局
未报告次要终点
研究者
研究点 (3)
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