Longterm Efficiency and Safety of Intravitreal Injections With Bevacizumab in Patients With Neovascularisation or Macular Edema
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Slit lamp examination
研究概览
简要总结
Although the safety and efficacy of bevacizumab has been established in several phase 3 trials, there is only little documented about the long-term safety and efficacy in the 'real-world practice' in large populations from different regions.
Therefore the investigators evaluate the long-term safety and efficacy of intravitreal treatment with bevacizumab by registration of best corrected visual acuity, side-effects and central retinal thickness as measured with the ocular coherence tomography if available. This will allow the investigators to compare the results of their centre with the results of several phase 3 trials from the literature and will guide improvements in their treatment protocols.
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
- 否
入选标准
- •Age ≥ 18 years of either gender
- •Written informed consent must be obtained before any intravitreal injection of bevacizumab is performed
- •Visual impairment predominantly due to abnormal new vessel ingrowth and/or macular edema. The presence of fluid (intraretinal, subretinal or sub-RPE) detected clinically or on the ocular coherence tomography.
- •If both eyes are eligible for the study, both eyes can be included in the study.
排除标准
- •Women who are pregnant or breastfeeding (pregnancy defined as the state of a female after conception until the termination of gestation, confirmed by a positive human chorionic gonadotropin laboratory test (> 5mIU/mL)
- •Women of child bearing potential must be practicing effective contraception implemented during the trial and for at least 28 days following the last dose of study medication
- •Tromboembolic event (CVA or transient ischemic attack, AMI) less than 3 months prior to the intravitreal injection of bevacizumab
- •History of hypersensitivity for bevacizumab.
研究组 & 干预措施
open label
干预措施: Bevacizumab Injection [Avastin] (Drug)
结局指标
主要结局
Slit lamp examination
时间窗: every visit, up to ten years
will be performed with a 1, 3 or 6 month interval (or more frequent) as long as there are signs of disease activity
Fluorescein Angiography and Ocular Coherence Tomography
时间窗: annually, up to ten years
fluorescein angiography and ocular coherence tomography. The necessity of these investigations is determined by the degree of activity and as deemed necessary by the investigator.
Best Corrected Visual Acuity
时间窗: every visit, up to ten years
will be performed with a 1, 3 or 6 month interval (or more frequent) as long as there are signs of disease activity
Dilated Fundoscopy
时间窗: every visit, up to ten years
will be performed with a 1, 3 or 6 month interval (or more frequent) as long as there are signs of disease activity
Central Retinal Thickness
时间窗: annually, up to ten years
central retinal thickness as measured with the ocular coherence tomography
次要结局
- side-effects(annually, up to ten years)