Intravitreal Bevacizumab for the Treatment of Patients With Low Vision Due to Neovascular Age-related Macular Degeneration
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- change in best-corrected visual acuity
研究概览
简要总结
The purpose of this study is to compare the effectiveness of intravitreal bevacizumab injection (IVBI) with respect to simple observation in patients with subfoveal choroidal neovascularisation (CNV) secondary to age-related macular degeneration (AMD) presenting at baseline with best corrected visual acuity (BCVA) less than 20/200.
详细描述
There is no clear indication regarding the treatment of patients with subfoveal choroidal neovascularisation (CNV) secondary to age-related macular degeneration (AMD) presenting at baseline with best corrected visual acuity (BCVA) less than 20/200.
Treatment of eyes with low visual acuity could lead to a waste of resources, without any functional and social improvements.
Aim of the present study is to compare the effectiveness of intravitreal bevacizumab injection (IVBI) with respect to simple observation in
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age-related macular degeneration
- •naïve subfoveal choroidal neovascularization
- •best-corrected visual acuity less then 20/200
排除标准
- •previous treatments
- •any other condition able to limit the visual improvement
研究组 & 干预措施
bevacizumab
three-monthly intravitreal bevacizumab, followed by PRN monthly injection on the basis of the detection of any fluid on the optical coherence tomography
干预措施: Bevacizumab (Drug)
结局指标
主要结局
change in best-corrected visual acuity
时间窗: 6 months
change in best-corrected visual acuity at the end of the follow-up
次要结局
- change in central macular thickness(6 months)
- NEI VFQ-25 scores(6 months)