Prospective Randomized Controlled Study of Intravitreal Injection of 0.16 mg Bevacizumab One Day Before Surgery for Proliferative Diabetic Retinopathy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Reoperation
研究概览
简要总结
We hypothesized that to reduce the adverse effects of intravitreal bevacizumab on ocular tissue and whole body, intravitreal injection of a low concentration of bevacizumab and conducting vitrectomy shortly after the injection is useful. In the present prospective, double-masked, randomized, controlled study, we aimed to verify the usefulness of intravitreal injection of 0.16 mg/0.05 ml bevacizumab one day before conducting vitrectomy for PDR.
详细描述
Early postoperative hemorrhage in proliferative diabetic retinopathy (PDR) patients is a major complication. Intravitreal injection of anti-vascular endothelial growth factor (VEGF) has reported to reduce vitreous hemorrhage. Recently, numerous reports have shown the efficacy of reducing neovascularization activity before vitrectomy by preoperative intravitreal injection of anti-VEGF agents. When intravitreal bevacizumab (IVB) injection is used as an adjunct therapy, a shortterm effect is needed. Because it is reported some adverse events caused by bevacizumab injection. Hattori et al reported intravitreal injection of 0.16 mg/0.05 ml bevacizumab in PDR patients marked blockage of intravitreal VEGF concentrations in the pilot study. The purpose of this study is to evaluate low dose of intravitreal bevacizumab as a preoperative adjunct therapy reduce the postoperative vitreous hemorrhage. This study involves PDR patients who underwent vitrectomy between May 2012 and August 2013 at Surugadai Hospital of Nihon University. The risks to participants are accompanied by the intravitreal injection of bevacizumab (especially the possibility of endophthalmitis and thromboembolic events).
Between June 2012 and August 2013, one investigator (AM) randomized PDR patients with an indication for primary 25-gauge vitrectomy into a sham group and an IVB group. One day after injection, three surgeons except AM conducted the surgeries. Vitreous samples were collected at the start of surgery, and intraoperative and postoperative complications were evaluated.
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
- Double (Participant, Care Provider)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Proliferative Diabetic Retinopathy (PDR)
- •Indicated for vitrectomy
排除标准
- •History of intraocular surgery, intravitreal injection of drugs or sub-Tenon injection of steroids or retinal photocoagulation within 6 months
研究组 & 干预措施
Sham injection and vitrectomy
Sham injection one day before vitrectomy.
干预措施: Vitrectomy (Procedure)
Bevacizumab injection and vitrectomy
0.16 mg/0.05 ml bevacizumab intravitreal injection one day before vitrectomy.
干预措施: Bevacizumab (Drug)
Bevacizumab injection and vitrectomy
0.16 mg/0.05 ml bevacizumab intravitreal injection one day before vitrectomy.
干预措施: Vitrectomy (Procedure)
Sham injection and vitrectomy
Sham injection one day before vitrectomy.
干预措施: Sham injection (Device)
结局指标
主要结局
Reoperation
时间窗: 1 month
Vitreoretinal reoperation due to recurrent vitreous hemorrhage.
次要结局
- Surgical Time(End of surgery.)
- Gas Tamponade(End of surgery.)
- Intra Operative Hemorrhage(End of the surgery.)
- Postoperative Vitreous Hemorrhage.(1 month)
- Vascular Endothelial Growth Factor Concentration in Vitreous(Start of surgery.)
- Endolaser Photocoagulation(End of surgery.)
- Postoperative Best Corrected Visual Acuity(1 mouth after surgery.)
- Best Corrected Visual Acuity Change(1 month)
- Iatrogenic Retinal Tears(End of surgery.)
- Postoperative Neovascular Glaucoma(Within 1 month after the surgery.)
- Elevated Intraocular Pressure(Within 1 month after the surgery.)
- Silicon Oil Tamponade(End of surgery.)
