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临床试验/NCT01166594
NCT01166594已完成4 期

Use of Bevacizumab in Trabeculectomy Surgery. A Prospective, 2 Centre, Randomized, Controlled Trial

Sunnybrook Health Sciences Centre1 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2010年6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
59
试验地点
1
主要终点
Intraocular Pressure

研究概览

简要总结

When a patient with glaucoma who has a pressure that is too high and causing damage to their vision, despite receiving the maximum amount of medication that can be tolerated, the decision is made to have glaucoma surgery. Trabeculectomy is the most common form of glaucoma surgery used to treat open angle glaucoma. During trabeculectomy, an opening is created in the eye and partially covered with a flap of tissue. This new opening allows fluid to drain out of the eye bypassing the clogged drainage channels that are malfunctioning in patients with glaucoma. Studies have found that trabeculectomy significantly reduces vision loss and lowers eye pressure.

However, many people need another trabeculectomy or other glaucoma surgery because the surgery may fail either early or much later because the body closes the drain created by the surgeon. The surgery is also less likely to work in patients with darker pigmentation, children who have congenital glaucoma, people with difficult to control glaucoma with new blood vessels growing on the iris, diabetes or persons with prior eye surgery. As a result, the investigators need to find ways to improve the longterm survival of trabeculectomy surgery in all patients.

详细描述

The usual treatment is to not have an injection of Bevacizumab on the third through fifth day after trabeculectomy surgery. Topical anaesthetic drops to numb the eye will be given, prior to being given the tested medicine. Once the eye has been anaesthetized, the medication will be injected into the potential space created during the glaucoma surgery, also called a bleb, using a standard small syringe. The patient will receive an injection of either 1.25mg (0.05ml) of Bevacizumab or Balanced Salt Solution (BSS) into the trabeculectomy bleb that had been created in the surgery. Participants will be randomly (by chance) placed in one of the 2 study groups. There will be a 50% chance of being placed in either group. There will be 60 people who will participate in this study at 2 centres throughout the Toronto region. The length of this study for participants is 12 months, and the entire study is expected to take about 18 months to complete.

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
Triple (Participant, Care Provider, Investigator)

入排标准

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

入选标准

  • Age more than 18 years old
  • Patients with glaucoma that is inadequately controlled on maximal tolerated medical therapy and scheduled for trabeculectomy surgery (with/without combined cataract extraction)
  • Decision makers fluent in English
  • Decision makers able to understand and read consent form

排除标准

  • Patients with active intraocular inflammation/uveitis or neovascular glaucoma
  • History of previous trabeculectomy surgery or prior retinal detachment with scleral buckle placement in the surgical eye
  • Aphakia in surgical eye
  • Pregnant and nursing women
  • Unable to fulfill inclusion criteria
  • Refusal of consent

研究组 & 干预措施

Bevacizumab

Experimental

Tested Drug

干预措施: Bevacizumab (Drug)

Control

Placebo Comparator

Control - BSS

干预措施: Control (Drug)

结局指标

主要结局

Intraocular Pressure

时间窗: One year

Intraocular pressure comparison between the two groups at one year following surgery. A window of ±14 days was allowed for the one-year visit

次要结局

  • Improved Bleb Appearance(One year)
  • The Number of Participants Who Received 5-Fluorouracil (5-FU) Injections(One year)

研究者

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

Dr. Catherine Birt

MD

Sunnybrook Health Sciences Centre

研究点 (1)

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