NCT02663141已完成2 期
Randomized Clinical Trial of Intravitreal Bevacizumab Versus Intravitreal Bevacizumab Combined With Losartan in the Treatment of Diabetic Macular Edema
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Difference in frequency of intravitreal Bevacizumab injection between arms
研究概览
简要总结
The aim of this study is to determine whether oral losartan is effective in the treatment of diabetic macular edema (DME) as an adjuvant for intravitreal bevacizumab (IVB).
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All type 2 diabetes mellitus patients with clinically significant macular edema(CSME), except those mentioned as exclusion criteria
排除标准
- •Patients with Uncontrolled hypertension
- •Patients with Proliferative diabetic retinopathy
- •Patients Who received angiotensin converting enzyme inhibitor(ACEI) or angiotensin receptor blocker(ARB)
- •Previous treatment for diabetic retinopathy (e.g., laser photocoagulation, photodynamic therapy, intravitreal injections of steroids, or anti-vascular endothelial growth factor, retinal surgery)
- •media opacities
- •evidence of any other ocular disease(e.g., glaucoma, uveitis, age related macular degeneration or etc.,)
- •Pathologic myopia > 6 Diopter
- •Patients with poor fixation or cooperation
- •Patients with renal or cardiac disease
研究组 & 干预措施
Losartan
Experimental
Oral losartan 50 mg daily for 6 months
干预措施: Losartan (Drug)
Losartan
Experimental
Oral losartan 50 mg daily for 6 months
干预措施: Intravitreal bevacizumab (Drug)
Placebo
Placebo Comparator
Oral placebo daily for 6 months
干预措施: Intravitreal bevacizumab (Drug)
Placebo
Placebo Comparator
Oral placebo daily for 6 months
干预措施: Placebo (Drug)
结局指标
主要结局
Difference in frequency of intravitreal Bevacizumab injection between arms
时间窗: Within 6 months from therapy
difference in ETDRS best-corrected visual acuity (BCVA) between arms
时间窗: Within 6 months from therapy
次要结局
- change in central macular thickness(measured by spectral domain optical coherence tomography)(Within 6 months from therapy)
研究者
研究点 (1)
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