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临床试验/NCT01342159
NCT01342159已完成不适用

Comparative Treatment of Intravitreal Bevacizumab and Triamcinolone Acetonide on Diabetic Macular Edema

Hallym University Medical Center1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2009年3月最近更新:
适应症

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

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

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)

研究者

申办方类型
Other

研究点 (1)

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