Systemic Absorption of Bevacizumab and Ranibizumab in Humans Treated for Diabetic Macular Edema
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Maximum Concentration (Cmax) of Anti-VEGF Antibody
研究概览
简要总结
Currently, two similar medications are available for injection into the eye to treat a variety of eye diseases. These medications are called ranibizumab (Lucentis) and bevacizumab (Avastin). They both have a similar mechanism of action and work equally well, however only ranibizumab was designed for use in the eye. It is significantly more expensive per injection than bevacizumab (by a factor of roughly 40x).
In published studies trends have been noted towards an increased rate of systemic side effects such as heart attacks and strokes. This is presumably due to absorption of the drug(s) from the eye into the bloodstream, however this has never been shown before. The purpose of the investigators study was to compare the bloodstream levels of bevacizumab and ranibizumab at various time points after injection into the eye. This required the creation of a sophisticated assay to measure blood levels of the drugs.
详细描述
see above
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •patients in whom anti-vascular endothelial growth factor (VEGF) therapy is indicated for the treatment of diabetic macular edema
- •able to return for extra clinic visits according to study schedule
排除标准
- •active malignancy
- •previous retinal laser treatment
- •previous anti-VEGF therapy
- •previous vitrectomy
研究组 & 干预措施
Ranibizumab
intravitreal injection of 0.5mg ranibizumab in usual fashion
干预措施: Ranibizumab (Drug)
Bevacizumab
intravitreal injection of 1.25mg bevacizumab in usual fashion
干预措施: Bevacizumab (Drug)
结局指标
主要结局
Maximum Concentration (Cmax) of Anti-VEGF Antibody
时间窗: 1 month
The serum concentrations of anti-VEGF antibody (bevacizumab or ranibizumab) will be measured pre-injection as well as at various time points after injection (1 day, 1 week, 2 weeks, 1 month). These time points are selected based on previously completed animal studies. The Cmax will be compared between bevacizumab and ranibizumab.
次要结局
未报告次要终点
研究者
Dr. Sanjay Sharma
Principal Investigator
Queen's University