A Prospective Matched Cohort Study of Intravitreal Topotecan in the Repair of Rhegmatogenous Retinal Detachment with Proliferative Vitreoretinopathy
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Recurrent RRD secondary to PVR
研究概览
简要总结
Intravitreal topotecan has anti-inflammatory, anti-proliferative and anti-fibrotic activity that we hypothesize may exhibit high efficacy for the treatment of proliferative vitreoretinopathy (PVR) in patients with rhegmatogenous retinal detachment (RRD). A high efficacy for intravitreal topotecan has been exhibited in cell cultures of PVR. At the same time, intravitreal topotecan has been routinely used in the treatment of vitreous seeds from retinoblastoma. At doses of 5-30 micrograms per injection, no adverse events have been reported with the use of intravitreal topotecan. Therefore, the current prospective matched phase II trial aims to investigate the efficacy and safety of intravitreal topotecan for severe PVR in patients with RRD.
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
- Treatment
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Intravitreal topotecan with pars plana vitrectomy with or without scleral buckle
干预措施: Intravitreal topotecan (Drug)
Intravitreal topotecan with pars plana vitrectomy with or without scleral buckle
干预措施: Pars plana vitrectomy with or without scleral buckle (Procedure)
Pars plana vitrectomy with or without scleral buckle
干预措施: Pars plana vitrectomy with or without scleral buckle (Procedure)
结局指标
主要结局
Recurrent RRD secondary to PVR
时间窗: 6 months or last follow-up
次要结局
- Proliferative vitreoretinopathy grade(6 months or last follow-up)
- Best corrected visual acuity change from baseline(6 months or last follow-up)
- Best corrected visual acuity(6 months or last follow-up)
- Retinal reattachment rate(6 months or last follow-up)
- Complications(6 months or last follow-up)