A Prospective, Randomized Study on Intravitreal Ozurdex for Preventing Recurrent Vitreous Hemorrhage Following Pars Plana Vitrectomy for Proliferative Diabetic Retinopathy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Reoperation
研究概览
简要总结
To evaluate if intravitreal Ozurdex can reduce the incidence of recurrent vitreous hemorrhage after primary pars plana vitrectomy (PPV) in patients with proliferative diabetic retinopathy (PDRP).
详细描述
To perform a randomized, controlled, study on patients that undergo PPV for vitreous hemorrhage secondary to PDRP. Half of the patients will receive an intravitreal Ozurdex implant immediately after surgery. The primary outcome measure is the proportion of patients that, due to rebleeding within 12 months, have a second PPV. Secondary outcome measures include the number of episodes of vitreous hemorrhage that occur within 12 months after surgery but clear spontaneously.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with vitreous hemorrhage undergoing PPV for PDRP
排除标准
- •Previous PPV
- •Vitreous hemorrhage of non-PDRP origin
研究组 & 干预措施
Sham
Vitrectomy only
干预措施: Vitrectomy (Procedure)
Intravitreal Ozurdex
Intravitreal Ozurdex after vitrectomy
干预措施: Intravitreal dexamethasone implant (Drug)
结局指标
主要结局
Reoperation
时间窗: 12 months
The proportion of patients that, due to re-bleeding within 12 months, have a second PPV
次要结局
- Rebleeding(12 months)
研究者
Anders Kvanta
Professor
St. Erik Eye Hospital