Comparative Treatment of Intravitreal Bevacizumab and Triamcinolone Acetonide on Diabetic Macular Edema
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Visual acuity
研究概览
简要总结
One of the most frequent complications of diabetic retinopathy is diabetic macular edema. Recently, intravitreal bevacizumab and intravitreal triamcinolone were the most popular therapeutic modalities. However, as the long term effects of intravitreal bevacizumab and intravitreal triamcinolone on visual acuity and macular thickness have not been compared, it was the purpose of the present study to compare these treatment effects
详细描述
Randomization of intravitreal bevacizumab, intravitreal triamcinolone, intravitreal bevacizumab with triamcinolone on eyes with diabetic macular edema
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 (Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetic macular edema (central macular thickness greater than 300 mm on optical coherence tomography )
排除标准
- •history of glaucoma or ocular hypertension (defined as an intraocular pressure higher than 22 mmHg)
- •an ocular condition (other than diabetes) that, in the opinion of the investigator, might affect macular oedema or alter visual acuity during the course of the study (e.g. retinal vein occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, Irvine-Gass Syndrome, etc.)
- •systemic corticosteroid therapy history of thromboembolic event (including myocardial infarction or cerebral vascular accident)
- •major surgery within the prior 6 months or planned within the next 28 days
研究组 & 干预措施
Intravitreal Triamcinolone injection
干预措施: Intravitreal injection (Procedure)
Intravitreal bevacizumab injection
干预措施: Intravitreal injection (Procedure)
intravitreal bavacizumab with triamcinolone
干预措施: Intravitreal injection (Procedure)
结局指标
主要结局
Visual acuity
时间窗: baseline, 1 month, 3 months, 6month, 9 month, 12 month
次要结局
- Central macular thickness(baseline, 1 month, 3 months, 6 months, 12months)