Phase III Study of Efficacy and Safety of Intravitreal Bevacizumab in the Treatment of Choroidal Neovascular Membranes Associated to High Myopia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 7
- 主要终点
- Improvement in Visual Acuity assessed by ETDRS
研究概览
简要总结
The purpose of this study is to determine the efficacy and safety of intravitreal injections of bevacizumab in High Myopia´s choroidal neovascularization versus the standard treatment of Photodynamic therapy.
详细描述
Bad response in choroidal neovascularization in High myopia to Photodynamic therapy, which is the current approved treatment for that pathology, and the high incidence of this pathology in these patients, together with the great functional impact in their vision has fostered the search for new therapeutic strategies.
Intravitreal bevacizumab has already been tested in small series of patients with choroidal neovascularization associated to high myopia, whether as first treatment option or after the failure of photodynamic therapy with good results. In the published series an improvement of visual acuity is described after 1-2 injections, with a reduction in the macular edema and a good safety profile.
The lack of published trials that describe the efficacy of frequency of treatment in this pathology is the main reason for this trial.
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
- Single (Outcomes Assessor)
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
- •Patient at least 18 years old
- •High Myopia with one of the following:
- •6 or more sphere diopters in the study eye
- •Axial length of the eye greater than 26 millimeters
- •Active subfoveal/juxtafoveal choroidal neovascularization confirmed by Fluorescein angiography and Ocular coherence tomography.
- •Visual acuity loss of less than 6 months of evolution related to the neovascular lesion, as stated by investigator´s opinion.
- •Patients previously treated with Photodynamic therapy are allowed to participate as long as the last treatment has been performed more than 3 months upon entering the study.
- •Signed informed consent.
- •Signed data protection consent.
- •Women of childbearing potential must provide a negative pregnancy test at inclusion and must commit to the use of a contraceptive treatment during the whole study.
排除标准
- •Previous vitrectomy surgery in the study eye.
- •Tractional maculopathy and/or epiretinal membrane evaluated by Ocular coherence tomography.
- •Opacities that may not allow correct fundus assessment.
- •Lack of integrity of the posterior lens capsule in pseudoaphakic patients.
- •Patients that may not want/be able to complete the study, based in the investigator opinion.
研究组 & 干预措施
Intravitreal Bevacizumab
Intravitreal injections of bevacizumab
干预措施: Intravitreal Injection (Drug)
Visudyne
Photodynamic Therapy with Visudyne
干预措施: Photodynamic Therapy (Visudyne) (Drug)
结局指标
主要结局
Improvement in Visual Acuity assessed by ETDRS
时间窗: Every month during first year - Every three months during the second year
次要结局
- Central macular thickness with Ocular Coherence Tomography(Every month during first year - Every three months during the second year)
- Complications that may arise from intravitreal injection(Every treatment visit - Once per month during the first 3 months. Reteatments depending on Visual acuitiy evolution and retinal thickness)