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Prospective Randomized Controlled Study of Intravitreal Injection of Bevacizumab for Proliferative Diabetic Retinopathy

2014年6月11日 更新者:Ayumu Manabe、Nihon University

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

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.

研究概览

详细说明

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.

研究类型

介入性

注册 (实际的)

69

阶段

  • 第四阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Tokyo、日本、101-8309
        • Surugadai Nihon university hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Clinical diagnosis of Proliferative Diabetic Retinopathy (PDR)
  • Indicated for vitrectomy

Exclusion Criteria:

  • History of intraocular surgery, intravitreal injection of drugs or sub-Tenon injection of steroids or retinal photocoagulation within 6 months

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
有源比较器:Bevacizumab injection and vitrectomy
0.16 mg/0.05 ml bevacizumab intravitreal injection one day before vitrectomy.
0.16 mg/0.05 ml bevacizumab (single injection on 1 day before operation)
其他名称:
  • 阿瓦斯汀
vitrectomy of 25 gauge system.
假比较器:Sham injection and vitrectomy
Sham injection one day before vitrectomy.
vitrectomy of 25 gauge system.
Sham injection one day before vitrectomy

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Reoperation
大体时间:1 month
Vitreoretinal reoperation due to recurrent vitreous hemorrhage.
1 month

次要结果测量

结果测量
措施说明
大体时间
Intra Operative Hemorrhage
大体时间:End of the surgery.
Calculate the number of coagulators for the intra operative hemorrhage.
End of the surgery.
Postoperative Vitreous Hemorrhage.
大体时间:1 month
Postoperative vitreous hemorrhage that is permitted within 4 weeks after surgery.
1 month
Vascular Endothelial Growth Factor Concentration in Vitreous
大体时间:Start of surgery.
Vascular endothelial growth factor concentration in vitreous at the start of vitrectomy.
Start of surgery.
Endolaser Photocoagulation
大体时间:End of surgery.
Number of intraoperative endolaser photocoagulation.
End of surgery.
Iatrogenic Retinal Tears
大体时间:End of surgery.
The number of participants who had intraoperative iatrogenic retinal tears.
End of surgery.
Surgical Time
大体时间:End of surgery.
End of surgery.
Postoperative Best Corrected Visual Acuity
大体时间:1 mouth after surgery.

Best corrected visual acuity was measured using the Landolt ring chart, and the result was converted to logMAR notation for analysis.

The minimum of the scale is 2.0 and the maximum of the scale is -0.3. The higher values represent a worse outcome.

1 mouth after surgery.
Best Corrected Visual Acuity Change
大体时间:1 month

Best corrected visual acuity change was calculated by postoperative logMAR visual acuity minus preoperative logMAR visual acuity.

The higher values represent a worse outcome.

1 month
Postoperative Neovascular Glaucoma
大体时间:Within 1 month after the surgery.
The number of participants with progressive or persistent neovascular glaucoma after surgery.
Within 1 month after the surgery.
Elevated Intraocular Pressure
大体时间:Within 1 month after the surgery.
The number of participants with elevated intraocular pressure after surgery.
Within 1 month after the surgery.
Gas Tamponade
大体时间:End of surgery.
The number of participants with gas tamponade at the end of the surgery.
End of surgery.
Silicon Oil Tamponade
大体时间:End of surgery.
The number of participants with silicon oil tamponade at the end of the surgery.
End of surgery.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 学习椅:Ayumu Manabe

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2012年5月1日

初级完成 (实际的)

2013年8月1日

研究完成 (实际的)

2014年3月1日

研究注册日期

首次提交

2013年5月13日

首先提交符合 QC 标准的

2013年5月13日

首次发布 (估计)

2013年5月15日

研究记录更新

最后更新发布 (估计)

2014年7月14日

上次提交的符合 QC 标准的更新

2014年6月11日

最后验证

2014年6月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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