Efficacy and Safety of Intravitreal Bevacizumab for the Improvement of Severe Non-proliferative Diabetic Retinopathy Without DME: a Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 100
- 主要终点
- Percentage of patients with equal or more than 2 stages of progression in diabetic retinopathy staging
研究概览
简要总结
In this randomized clinical trial, 100 eyes with nonproliferative diabetic retinopathy will be included and divided randomly into 2 groups: Intravitreal Bevacizumab group (50 eyes) that receive 6 bimonthly intravitreal bevacizumab, and control group (50 eyes) that undergo regular follow-up for Diabetic Retinopathy. Diabetic macular edema (DME) will be treated independently in all groups by intravitreal bevacizumab. Primary outcome will be the percentage of patients with progression of 2 or more stages through international diabetic retinopathy staging. The secondary measures will be changes in best corrected visual acuity (BCVA) and central macular thickness (CMT), and number of examinations and 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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of severe NPDR with DRSS score more than 53 with or without diabetic macular edema
- •Diagnosis of DM (type 1 or 2) with age more than 18 years' old
- •Visual acuity from 20/25 to 20/40 according to Snellen chart examination or more than 69 letters according to ETDRS chart
排除标准
- •Presence of proliferative diabetic retinopathy features including vitreous hemorrhage or optic disc or retinal neovascularization
- •History of retinal laser photocoagulation
- •Tractional retinal detachment involving the macula
- •Evidence of neovascularization of angle on examination
- •Macular edema due to a cause other than DME
- •Any ocular condition which may change visual acuity during the study
- •History of intravitreal injection of anti-vascular endothelial growth factor agent in past 3 months
- •History of any use of intravitreal corticosteroid
- •History of major intra-ocular surgery except cataract surgery in the past 6 months
- •History of thromboembolic every in the past 3 months
研究组 & 干预措施
Intravitreal Bevacizumab IVB group
干预措施: Intravitreal Bevacizumab IVB (Drug)
undergo regular follow-up for Diabetic Retinopathy
干预措施: Follow-up with regular examination for determination of DR progression (Other)
结局指标
主要结局
Percentage of patients with equal or more than 2 stages of progression in diabetic retinopathy staging
时间窗: 12 months
Multiple fundus photographs interpreted by a single vitreoretinal surgeon who is blind to the study groups
次要结局
- Best corrected visual acuity(12 months)
- Number of visits(12 months)
- Central retinal thickness(12 months)
研究者
Zahra Rabbani Khah
Head of ophthalmic research center
Shahid Beheshti University of Medical Sciences