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临床试验/NCT00548197
NCT00548197已完成1 期

Preoperative Injection of Bevacizumab Prior to Vitreoretinal Surgery in Diabetic Tractional Retinal Detachment

Iran University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2007年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
40
试验地点
1
主要终点
Best Corrected Visual Acuity

研究概览

简要总结

Vitreoretinal surgery for epiretinal proliferation tractional retinal detachment associated with proliferative diabetic retinopathy (PDR) is often complicated by hemorrhage from fibrovascular tissue. To control the bleeding during tissue dissection multiple measures and techniques are used.

Bevacizumab is an anti VEGF antibody which has been used to induce regression of ocular neovascularization. Its intraocular injection has been increasingly used for treatment of choroidal neovascularization (CNV) associated with age related macular degeneration (AMD) with fairly good success.Also it has been shown to be effective for treatment of PDR complicated with vitreous hemorrhage and iris neovascularization. We hypothesized that if anti-angiogenic agents, such as bevacizumab are injected into the vitreous cavity before vitrectomy in cases of PDR; there may be partial regression of neovascularization resulting in less intraoperative (and postoperative) hemorrhage. This can make the operation easier and shorter and lessen the need for intraocular cautery..

In this study diabetic patients who are candidated for vitrectomy with similar complexity scores will be randomized to preoperative injection or no injection of 2.5 mg Bevacizumab .In the injection group, 2.5 mg of bevacizumab (0.1 ml of commercially available Avastin vial, Genentech, inc. South San Francisco, CA) will be injected into the vitreous 3-5 days before operation.

During each operation, the number of endodiathermy applications, backflush needle applications and the duration of surgery will be recorded by an independent observer. Also, type of tamponade, post operation vitreous hemorrhage and 3 months postoperative visual acuities wil be recorded. all these parameters will be compared in two groups.

详细描述

Eligibility criteria:

Diabetic tractional retinal detachment-complexity score between 4 and 8

Main outcome measures:

best corrected visual acuity-anatomic condition of the retine(re-attachment of the retina)

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Those patients with tractional retinal detachment who are candidated for pars plana vitrectomy.
  • Complexity score between 4 and 8.

排除标准

  • Previous vitreoretinal surgery.
  • Presence of any other vitreoretinal pathology such as past or present uveitis, and retinal artery or vein occlusion.

研究组 & 干预措施

Intervention group

Experimental

Intravitreal Bevacizumab will be injected 2.5 mg IVB 3-5 days before operation in diabetic patients who were candidates for vitrectomy before performing pars plana vitrectomy

干预措施: Bevacizumab (Drug)

结局指标

主要结局

Best Corrected Visual Acuity

时间窗: last follow up, an average of 7 months post-operation

Post operative best corrected visual acuity ( best distance vision with eyeglasses or contact lenses)

次要结局

  • Anatomic Status of the Retina(Last follow up, an average of 7 months post-operation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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