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临床试验/NCT01229202
NCT01229202撤回4 期

Use of Vascular Endothelial Growth Factor Inhibitor, Bevacizumab to Modulate the Outcomes of Trabeculectomy Surgery

Nova Scotia Health Authority1 个研究点 分布在 1 个国家开始时间: 2008年7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
撤回
试验地点
1
主要终点
post surgery IOP (Intra Ocular Pressure Measurement)

研究概览

简要总结

Vascular epithelial growth factor (VEGF) plays a critical role in vessel growth and wound healing. Bevacizumab, a non specific VEGF inhibitor, has been successfully used for the treatment of eye diseases associated with neovascularization. The purpose of this randomized study is 1) to investigate the effects of intraoperative subtenon injection of bevacizumab on the outcomes of trabeculectomy surgery. 2) to measure plasma and aqueous levels of VEGF and assess its association with the outcomes of trabeculectomy surgery. Trabeculectomy surgery, where a small drainage canal is created at the front of the eye, is the most common glaucoma surgery performed worldwide. The goal of the surgery is to control intraocular pressure. Failure of this procedure is most commonly caused by excessive scarring of the surgical site. If scarring occurs, the drainage canal can close. By adding Bevacizumab at the time of surgery, wound healing may be slowed and surgical failure prevented.

The results of this study will be helpful in the future development of new more effective and safe surgical techniques for treatment of glaucoma.

Patients who have given informed consent are randomized into two groups. One group receives standard of care for trabeculectomy surgery and the other group receives standard of care plus an injection of Bevacizumab at the surgery site. Both groups have a one time collection of ocular fluid and a blood sample taken from a vein in the arm. After surgery, patients are seen by their study doctor six times in the following year. At these visits measurements are taken of their visual acuity, eye pressure and blood pressure. The doctor does a clinical exam and at months six and twelve photographs of the patients' eye are taken.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

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

入选标准

  • any type of glaucoma, except neovascular or inflammatory
  • patients requiring trabeculectomy or combined cataract surgery with trabeculectomy surgery

排除标准

  • younger than 30 years of age
  • previous ocular surgeries excepting cataract surgeries
  • patients who have had or present with intraocular inflammation
  • neovascular glaucoma
  • patients who are aphakic
  • diabetic retinopathy

研究组 & 干预措施

standard of care

Active Comparator

standard of care for trabeculectomy surgery

干预措施: Bevacizumab (Drug)

bevacizumab arm

Active Comparator

干预措施: Bevacizumab (Drug)

结局指标

主要结局

post surgery IOP (Intra Ocular Pressure Measurement)

时间窗: one year post surgery

次要结局

  • systemic complications(one year post surgery)
  • postoperative visual acuity at 12 months(12 months post surgery)
  • bleb appearance(one year post surgery)
  • number of bleb needlings(one year post surgery)
  • number of glaucoma medications at 12 months postoperatively(one year post surgery)
  • need for another glaucoma surgery to control glaucoma(one year post surgery)
  • eye complications(one year post surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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