Establishment of the Initial Protocol With Intravitreal Bevacizumab for the Treatment of Choroidal Neovascularization Associated With High Myopia:3 vs 1.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 11
- 主要终点
- Early Treatment Diabetic Retinopathy Study (ETDRS) Best corrected visual acuity
研究概览
简要总结
The purpose of this protocol is to determine wether the initial protocol in the treatment of subfoveal choroidal neovascularization associated to High Myopia with bevacizumab intravitreal injections is more effective when using 3 doses vs using 1 single dose in the load period
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Active subfoveal/juxtafoveal choroidal neovascularization in high myopia confirmed by Fundus Fluorescein angiography and Optical Coherence Tomography
- •Best corrected visual acuity loss with less than 6 months of evolution, caused mainly by the neovascular lesion (based in investigator´s criteria)
- •No atrophy or fibrotic component that may prevent visual acuity improvement
- •Patients previously treated with Photodynamic Therapy are allowed to participate in this study
- •Signed informed consent
- •Signed data protection consent
- •Negative pregnancy test in potential childbearing women at screening, with accepted contraceptive method during the whole study
排除标准
- •Previous vitreous surgery in study eye
- •Tractional maculopathy or epiretinal membrane found in Optical Coherence Tomography
- •Media opacities that may prevent correct fundus assessment
- •Lack of posterior capsule integrity in pseudophakic patients
- •Patients with great possibilities of not being able to attend to study visits / follow visit procedures (investigator´s criteria)
- •Patients previously treated with intravitreal antiangiogenic injections
研究组 & 干预措施
3 Month Load with 9 month p.r.n.
3 Monthly bevacizumab injections with 9 p.r.n. monthly doses if patient meets the treatment criteria for each monthly visit
干预措施: Bevazizumab intravitreal injection (Drug)
Single Dose Load Phase
Single dose treatment with bevacizumab, followed by 2 sham injections if conditions are met in the months 2 and 3, and followed with bevacizumab monthly p.r.n. as per protocol
干预措施: Bevazizumab intravitreal injection (Drug)
结局指标
主要结局
Early Treatment Diabetic Retinopathy Study (ETDRS) Best corrected visual acuity
时间窗: 1 Year
Differences in best corrected visual acuity in the exit visit compared to the one obtained at screening visit
Retinal thickness
时间窗: 1 Year
Retinal thickness assessed by Spectral Domain Optical Coherence Tomography
Number of total injections during study
时间窗: 1 Year
Total count of bevacizumab intravitreal injections during the whole study
次要结局
未报告次要终点