NCT02320474已完成4 期
Efficacy of Aflibercept (Eylea®) on Choroidal Neovascularization (Type 3)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Mean change from baseline in Best Corrected Visual Acuity (BCVA)
研究概览
简要总结
This is a one-year pilot, interventional, prospective, single arm, non-randomized, multicentric (3 centers) controlled study that aims to evaluate the response of type 3 choroidal neovascularization to treatment by Aflibercept following a classic protocol.
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
- •Males or females aged more than 50 years
- •Patients with type 3 choroidal neovascularization assessed on FA, ICG and OCT
- •Exudation on SD-OCT scans defined by intraretinal cysts or subretinal fluid.
- •Best Corrected Visual Acuity at inclusion between 24 and 78 letters (ETDRS)
- •Media clarity, pupillary dilation and patient cooperation sufficient to allow fundus photographs of adequate quality
排除标准
- •Any contraindications as reported in the labelling of Aflibercept (Eylea®): Ocular or periocular infection, Active intraocular inflammation or Hypersensitivity.
- •Any previous history of intravitreal injections in the study eye for exudative AMD
- •Any secondary chorioretinal anastomosis due to retinal scar or fibrosis
- •Any history of vitrectomy
- •Media opacities preventing accurate imaging of the retina (cataract)
- •Any other retinal disorder possibly associated with type 3 CNV (epiretinal membrane, macular hole)
- •Confirmed intraocular pressure ≥25 mmHg or non-stable glaucoma.
研究组 & 干预措施
Aflibercept
Experimental
干预措施: Aflibercept (Drug)
结局指标
主要结局
Mean change from baseline in Best Corrected Visual Acuity (BCVA)
时间窗: 52 weeks
Mean change from baseline in Best Corrected Visual Acuity (BCVA) as measured by ETDRS letter score at 4 meters
次要结局
未报告次要终点
研究者
研究点 (2)
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