Comparison of Anti-vascular Endothelial Growth Factors Agents in the Treatment of Macular Edema Following Retinal Vein Occlusion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- change in central retinal thickness
研究概览
简要总结
Antagonists of the vascular endothelial growth factor (VEGF) pathway are effective in treating macular edema resulting from retinal vein occlusion (RVO). In the eye, the two most widely used anti-VEGF agents are ranibizumab and bevacizumab. Only ranibizumab has been FDA-approved for the treatment of macular edema from RVO, however bevacizumab has been used off-label by many ophthalmologists with good success. Furthermore, the cost of bevacizumab is less than one-tenth the cost of ranibizumab. Here the investigators conduct a six month randomized, prospective interventional trial comparing the effectiveness of ranibizumab with bevacizumab in the treatment of macular edema from RVO. Primary outcome measures are change in central retinal thickness. Secondary measures are change in visual acuity from baseline and change in angiographic properties of macular lesions from baseline after treatment.
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
- Single (Participant)
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
- •Ability to provide informed consent
- •Visual acuity of 20/40 - 20/320 in the study eye (regardless of relative APD)
- •Central foveal thickness (CFT) of > 250 microns as assessed by OCT (see below)
- •Diagnosis of retinal vein occlusion in the past 9 months
- •Age over 50 years
排除标准
- •History of previous intraocular surgery in the study eye, including pars plana vitrectomy (but not including uncomplicated cataract surgery), within 60 days of the screening visit
- •Inability to make study visits
- •Uncontrolled glaucoma in the study eye (defined as intraocular pressure (IOP) ≥ 25 mmHg) despite treatment with two or more topical pharmacological anti-glaucomatous medication)
- •Pregnancy or lactation
- •Evidence of any diabetic retinopathy on exam or history of diabetic macular edema within 12 weeks of study onset
- •Any intravitreal injections within 12 weeks of study onset
- •Prior retinal vein occlusion
- •History of pan-retinal photocoagulation within 3 months of study onset or anticipated within 4 months after study onset
- •History of cerebrovascular event or myocardial infarction within 3 months of study onset
研究组 & 干预措施
Ranibizumab
干预措施: Intravitreal injection of ranibizumab (0.5 mg per dose) (Drug)
Bevacizumab
干预措施: Intravitreal injection of bevacizumab (Drug)
结局指标
主要结局
change in central retinal thickness
时间窗: six months compared to baseline
central thickness is measured using optical coherence tomography (OCT)
次要结局
- change in best-corrected Snellen visual acuity(six months compared to baseline)
- change in fluorescein angiogram(six months compared to baseline)
研究者
Rhonda Weeks
Gaurav Shah, MD
Barnes Retina Institute