Intravitreal Bevacizumab for Proliferative Diabetic Retinopathy With New Dense Vitreous Hemorrhage After Full Panretinal Photocoagulation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- The percentage of eyes that vitreous hemorrhage has been completely resolved
研究概览
简要总结
To evaluate the efficacy of intravitreal bevacizumab injections for treatment of proliferative diabetic retinopathy (PDR) with new dense vitreous hemorrhage (VH) after previous full panretinal photocoagulation (PRP).
详细描述
The investigators will carry out a prospective study in patients with PDR and prior complete laser treatment who presented with new dense VH. All eyes will be treated with intravitreal injection of bevacizumab (1.25 mg). Complete ophthalmic examination and/or ocular ultrasonography will be performed at baseline and 1, 6, 12 weeks and 6, 9, 12 months after first injection. Re-injection will be done in non-clearing and recurrent VH.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with diabetes mellitus
- •proliferative diabetic retinopathy
- •prior complete panretinal photocoagulation
- •presented with new dense vitreous hemorrhage
排除标准
- •one-eyed patient
- •previous intraocular surgery
- •severe lens opacity precluding fundus examination
- •advance glaucoma
- •history of thromboembolic events such as myocardial infarction and cerebrovascular accident
- •uncontrolled systemic hypertension, systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg
- •known coagulation abnormalities or current use of anticoagulant medications other than aspirin
- •known allergies to any relevant drugs in this study
- •evidence of external ocular infection such as conjunctivitis and significant blepharitis.
研究组 & 干预措施
intravitreal bevacizumab injection
intravitreal injection of bevacizumab 1.25 mg
干预措施: intravitreal injection of bevacizumab (Drug)
结局指标
主要结局
The percentage of eyes that vitreous hemorrhage has been completely resolved
时间窗: 12 months
The patients with PDR and prior complete laser treatment who presented with new dense VH. All eyes were treated with intravitreal bevacizumab injection. Complete ophthalmic examination and/or ocular ultrasonography were performed at baseline and 1, 6, 12 weeks and 6, 9, 12 months after first injection.
次要结局
- The change in best corrected visual acuity (BCVA) from baseline(12 months)
研究者
Yosanan Yospaiboon
Professor
Khon Kaen University