Effect of Adjunctive Intravitreal Bevacizumab Before Panretinal Photocoagulation in Macular Thickness and Retinal Nerve Fiber Layer Thickness
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Central macular thickness
研究概览
简要总结
This study is to investigate the effect of adjunctive intravitreal bevacizumab (IVB) before panretinal photocoagulation (PRP) compared with only PRP on central macular thickness and retinal nerve fiber layer thickness in patients with severe diabetic retinopathy without macular edema.
详细描述
This prospective randomized study included 30 patients (60 eyes) with severe nonproliferative diabetic retinopathy or non-high-risk proliferative diabetic retinopathy. They had weekly PRP treatments in 3 sessions and they were randomly assigned to IVB group who had adjunctive IVB within 1 week before first PRP and control group who had only PRP. CMT, RNFL, and best-corrected visual acuity (BCVA) were measured
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with severe NPDR or early PDR without macular edema
- •best-corrected visual acuity (BCVA) of 20/25 or better
- •patients who were followed up for at least 6 months after the first PRP.
排除标准
- •patients with retinal or choroidal diseases except diabetic retinopathy
- •contraindications to fluorescein angiography (FA) or bevacizumab
- •patients who had previous treatments including anti-angiogenic medications and laser photocoagulation
- •patients with previous vitrectomy
- •patients with uncontrolled hypertension, a recent myocardial infarction or cerebral vascular accidents.
研究组 & 干预措施
IVB group
Patients were treated with IVB injections approximately within 1 week before the first PRP. Then patients had PRP, which was done in three sessions at weeks 0, 1, and 2 according to ETDRS guidelines. The superior, inferior, and nasal and temporal areas were treated sequentially.
干预措施: bevacizumab (Drug)
结局指标
主要结局
Central macular thickness
时间窗: 6 months after first PRP session
central macular thickness measured by Cirrus HD optical coherence tomography
次要结局
- Retinal nerve fiber layer thickness(6 months after first PRP session)
研究者
Dong Ho Park
Clinical professor
Kyungpook National University Hospital