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临床试验/NCT01854593
NCT01854593已完成4 期

Prospective Randomized Controlled Study of Intravitreal Injection of 0.16 mg Bevacizumab One Day Before Surgery for Proliferative Diabetic Retinopathy

Nihon University1 个研究点 分布在 1 个国家目标入组 69 人开始时间: 2012年5月最近更新:
适应症
干预措施
相关药物

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

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 Comparator

Sham injection one day before vitrectomy.

干预措施: Vitrectomy (Procedure)

Bevacizumab injection and vitrectomy

Active Comparator

0.16 mg/0.05 ml bevacizumab intravitreal injection one day before vitrectomy.

干预措施: Bevacizumab (Drug)

Bevacizumab injection and vitrectomy

Active Comparator

0.16 mg/0.05 ml bevacizumab intravitreal injection one day before vitrectomy.

干预措施: Vitrectomy (Procedure)

Sham injection and vitrectomy

Sham Comparator

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.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ayumu Manabe

Ayumu Manabe

Nihon University

研究点 (1)

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