Randomized Multi-center Clinical Study：Bevacizumab for Neovascular Age-related Macular Degeneration
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- EDTRS visual acuity score
研究概览
简要总结
Age-related macular degeneration (AMD) is one of primary blinding eye disease among people over 65 years in China. The anti-VEGF antibody treatment is proved useful for Neovascular Age-related Macular Degeneration (nAMD) by many studies. Bevacizumab is the only available low-cost type of anti-VEGF drug currently in China. This study is a multi-center, randomized trial of Bevacizumab effective dose and safety for nAMD. This study is to explore the effective therapeutic approach that the majority of patients in China can bear establishing a suitable treatment for China.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of neovascular Age-related macular degeneration
- •Signed informed consent
排除标准
- •No other ocular fundus diseases
研究组 & 干预措施
Bevacizumab 1
干预措施: Bevacizumab 1 (Drug)
Bevacizumab 2
干预措施: Bevacizumab (Drug)
结局指标
主要结局
EDTRS visual acuity score
时间窗: 0week(baseline), 6week, 12week, 18week, 24week, 30week, 36week, 42week, 48week
EDTRS visual acuity score is assessed at each timepoint for every group
次要结局
- macular thickness in OCT(0week(baseline), 6week, 12week, 18week, 24week, 30week, 36week, 42week, 48week)