Bevacizumab Versus Combined Bevacizumab and Triamcinolone for Refractory Diabetic Macular Edema; a Randomized Clinical Trial
试验速览
- 阶段
- 3 期
- 试验地点
- 2
- 主要终点
- Visual acuity
研究概览
简要总结
The purpose of this study is to compare the efficacy and safety of intravitreal injection of bevacizumab alone versus bevacizumab combined with triamcinolone for treatment of refractory diabetic macular edema.
详细描述
According to the early treatment diabetic retinopathy study (ETDRS), the treatment of choice for diabetic macular edema is laser therapy, which may be neither effective nor curative in some patients. Corticosteroids may have a beneficial effect on diabetic macular edema. Other newly introduced medications for macular edematous lesions are anti-VEGF vascular endothelial growth factor)drugs. In this randomized, sham-controlled, multicenter, three-arm clinical trial,we try to evaluate the safety and efficacy of intravitreal bevacizumab alone and in combination with intravitreal triamcinolone in the treatment of refractory 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
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cases with clinically significant macular edema (CSME) with persistent retinal thickening after initial or supplemental macular photocoagulation
排除标准
- •Monocularity,
- •History of vitrectomy,
- •Glaucoma or ocular hypertension,
- •Significant media opacity,
- •Existence of traction on the macula
结局指标
主要结局
Visual acuity
Central macular thickness
次要结局
- Cataract progression
- Intraocular pressure
- Anterior chamber reaction