Panretinal Photocoagulation Versus Panretinal Photocoagulation Plus Intravitreous Ranibizumab for High Risk Proliferative Diabetic Retinopathy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Fluorescein leakage area (mm2)
研究概览
简要总结
The purpose of this study is to evaluate the effects of panretinal photocoagulation plus intravitreal ranibizumab for the treatment of patients with high risk proliferative diabetic retinopathy in terms of changes in visual acuity and neovascularization area.
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 (Investigator)
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
- •Age ≥ 18 years old
- •High risk proliferative diabetic retinopathy
- •Visual acuity ≥ 20/800
- •No previous laser treatment for diabetic retinopathy
排除标准
- •Previous pars plana vitrectomy
- •Systemic thrombo-embolic events
- •Uncontrolled systemic hypertension
- •Conditions avoiding adequated documentation
- •Previous eye surgery in the last 6 months before inclusion in the study
研究组 & 干预措施
PRP plus ranibizumab
Patients will be submitted to panretinal photocoagulation plus intravitreal injections of ranibizumab
干预措施: Ranibizumab (Drug)
PRP plus ranibizumab
Patients will be submitted to panretinal photocoagulation plus intravitreal injections of ranibizumab
干预措施: Panretinal Photocoagulation (Procedure)
PRP
Patients will only be submitted to panretinal photocoagulation
干预措施: Panretinal Photocoagulation (Procedure)
结局指标
主要结局
Fluorescein leakage area (mm2)
时间窗: Week 48 after inclusion in the study
Neovascularization area measured during fluorescein agiography middle phase
次要结局
- CMT(Week 48 after inclusion in the study)
- LogMAR BCVA(Week 48 after inclusion in the study)
- Retina mid periphery visual field sensitivity change(Week 48 after inclusion in the study)
- Rod pathway integrity and oscillatory potential amplitudes(Week 48 after inclusion in the study)