NCT01189526Unknown3 期
A Randomized Trial Comparing Intravitreal Ranibizumab and Macular Laser Photocoagulation for the Treatment of Macular Edema Following Branch Retinal Vein Occlusion
Seoul Retina Investigator Group1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2009年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Best Corrected Visual Acuity (ETDRS letters)
研究概览
简要总结
This study is designed to evaluate the efficacy of intravitreal Ranibizumab in comparison with macular laser photocoagulation as treatments for macular edema secondary to branch retinal vein occlusion.
Characteristics of this study is as below
- Multicenter, randomized clinical trial. (intravitreal Ranibizumab 0.5mg injection vs. macular laser photocoagulation)
- After 48 weeks follow up, functional change(visual acuity)and anatomical change (central retinal thickness) would be evaluated
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptom duration < 6 Months, > 4 weeks
- •Visual acuity - less than 20/40 (73 letters) more than 20/400 (19 letters) in ETDRS chart
- •OCT - center involved retinal thickening : > 250 micrometers
- •clear media
- •well controlled hypertension (<140/90mmHg) and diabetes (6.5<HbA1c<9.5)
- •willing to return for all scheduled visits
排除标准
- •uveitis,NVG, exudative AMD, diabetic retinopathy, Irvine-Gass syndrome, OIS
- •any malignancy
- •previous treatment history - laser photocoagulation, intravitreal injection with any drug, vitrectomy
- •vitreomacular traction or epiretinal membrane
- •intraocular surgery in the study eye within 6 months
- •uncontrolled glaucoma ( > 30mmHg with anti-glaucoma medications)
- •optic neuropathy, amblyopia
- •A condition that in the opinion of the investigator would preclude a patient's participation in the study
研究组 & 干预措施
IVRI
Experimental
IVRI : intravitreal ranibizumab (0.5mg) injection
干预措施: Ranibizumab (Drug)
Laser
Active Comparator
Laser : macular laser photocoagulation
干预措施: macular laser photocoagulation (Procedure)
结局指标
主要结局
Best Corrected Visual Acuity (ETDRS letters)
时间窗: 48 weeks
次要结局
- Retinal Thickening(48 weeks)
研究者
研究点 (1)
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