The Comparison Between the Therapeutic Effect of Intravitreal Bevacizumab and Ziv-aflibercept in Diabetic Macular Edema
试验速览
- 阶段
- 2 期
- 入组人数
- 133
- 试验地点
- 1
- 主要终点
- visual acuity
研究概览
简要总结
In this double clinical trial 132 patient with the history of DME (Diabetic Macular Edema) to receive intravitreous bevacizumab at a dose of 1.25mg (44 patient) , ziv-aflibercept at dose of 1.25 mg (44 patient) , ziv-aflibercept at dose of 2.5 mg (44 patient) .
The study drugs were administered as often as every 4 weeks for 3 months.monitoring of best-corrected visual acuity, CST ( Central Subfield Thickness) by OCT (Optical coherence tomography) was done from base line ,4 weeks, 8weeks after injection.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The patient at least 18 years old had type 1 or 2 diabetes who presented with Central DME involvement (defined as retinal thickening involving 1mm central sub field thickness(CCT)
- •Have at least a BCVA ( best corrected visual acuity) between 20/50 to 20/320 Snellen equivalent
- •Have received to anti-VEGF( anti -vascular endothelial growth factor) and laser treatment within the previous 3 months
排除标准
- •Uncontrolled glaucoma/uncontrolled diabet , high risk PRP(pan-retinal photocoagulation), one eye
- •Prior treatment with intravitreal or peribulbar injection and laser therapy during the last 3 months
- •Substantial cataract, history of uveitis
- •Macular edema due to a cause other than DME
- •VMT(Vitreomacular traction ) and ERM (epiretinal membrane)
研究组 & 干预措施
Injection intravitreous bevacizumab
Injection intravitreous bevacizumab at a dose 1.25mg
干预措施: bevacizumab (Drug)
Injection ziv-aflibercept at dose of 1.25 mg
Injection ziv-aflibercept at dose of 1.25 mg
干预措施: ziv-aflibercept 1.25 mg (Drug)
Injection ziv-aflibercept at dose of 2.5 mg
Injection ziv-aflibercept at dose of 2.5 mg
干预措施: ziv-aflibercept 2.5mg (Drug)
结局指标
主要结局
visual acuity
时间窗: until 6 month
次要结局
- central subfield thickness(CCT)(until 6 month)
研究者
Zahra Rabbani Khah
Assistant Professor of Ophthalmology
Shahid Beheshti University of Medical Sciences