Comparison of Treatment Response to Intravitreal Injection of Combined Propranolol and Bevacizumab Versus Bevacizumab Monotherapy in Patients With Wet Age Related Macular Degeneration :A Clinical Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Macular Thickness
研究概览
简要总结
This study is designed to compare the effect of combined intravitreal Bevacizumab and Propranolol injection versus Bevacizumab monotherapy in patients with Age Related Macular Degeneration.
Methods:
In this study patients with Age Related Macular Degeneration who are naïve or had history of previous treatment are included. The eligible patients in randomized in two groups "Bevacizumab" and "Bavacizumab + propranolol" and in injected intravitreally for 3 times monthly. In "Bevacizumab+propranolol" group patients receive two injections at each session Bavacizumab and propranolol. In "Bevacizumab" group patients receive only Bevacizumab. The patients are followed for 6 months and central macular thickness and visual acuity is measured at baseline and monthly for 6 month. Baseline ancillary exams include Fluorescein Angiography and OCT-Angiography which is performed at the final exam as well. Patients needing any therapeutic intervention is addressed during the 6 month follow up period.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with Wet AMD and Vision less than 20/40
排除标准
- •History of cardiac ,renal, respiratory diseases (due to beta blocker toxicity),
- •Associated with other Macular abnormalities such as Diabetic Retinopathy, Macular traction
- •History of ocular inflammation
- •Subretinal fibrosis
- •History of Cataract surgey less than 6 months
- •History of Glaucoma Surgery ,Vitreoretinal surgery
- •Media opacity
研究组 & 干预措施
injection Combined Intravitreal bevacizumab and propranolol
patients receive two injections at each session Bavacizumab
干预措施: Combined Intravitreal bevacizumab and propranolol (Drug)
injection Intravitreal bevacizumab
patients receive only Bevacizumab
干预措施: Intravitreal bevacizumab (Drug)
结局指标
主要结局
Macular Thickness
时间窗: 1 month
Spectral Domain Optical Coherence Tomography
次要结局
- Visual acuity(1 month)
研究者
Zahra Rabbani Khah
Clinical Professor
Shahid Beheshti University of Medical Sciences