Bevacizumab Against Recurrent Retinal Detachment
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- Number of Participants (or Chart Reviews) With Complete Success of Primary Vitrectomy Surgery
研究概览
简要总结
The investigators hypothesize that bevacizumab instilled into the vitreous after primary retinal detachment surgery will reduce the formation of proliferative vitreoretinopathy and subsequent retinal re-detachment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Eyes with rhegmatogenous retinal detachment
排除标准
- •Presence of PVR
- •Need for a procedure other than primary PPV such as a scleral buckle with or without PPV, laser retinopexy, or pneumatic retinopexy.
- •Recent intravitreal injection of an anti-VEGF agent less than 3 months prior
- •Secondary retinal detachment repair
- •Use of silicone oil as tamponade agent
- •Patients less than 18 years of age
- •Pregnancy
- •Known allergy or contraindication to intravitreal bevacizumab
研究组 & 干预措施
Bevacizumab
Pars plana vitrectomy will be performed in the typical manner. After laser retinopexy and prior to air-gas exchange, intravitreal bevacizumab will be administered through the trocar. Either perfluoropropane (C3F8) or sulfur hexafluoride (SF6) gas will then be administered for long-term retinal tamponade and the vitrectomy ports closed in the usual manner.
干预措施: Bevacizumab (Drug)
结局指标
主要结局
Number of Participants (or Chart Reviews) With Complete Success of Primary Vitrectomy Surgery
时间窗: 6 months
Complete success of primary vitrectomy surgery, defined as retinal re-attachment without the need for any additional surgical procedures.
次要结局
- Number of Participants (or Chart Reviews) With Presence of Proliferative Vitreoretinopathy(6 months)