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临床试验/NCT01122966
NCT01122966Unknown2 期

The Effect of Intracameral and Subconjunctival Injections of Bevacizumab in Trabeculectomy With Antimetabolite

Samsung Medical Center1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2010年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
入组人数
40
试验地点
1
主要终点
intraocular pressure

研究概览

简要总结

The investigators plan to evaluate the additive effect of intracameral and subconjunctival injections of bevacizumab in trabeculectomies with other antimetabolites.

详细描述

Glaucoma filtration surgery is routinely utilized to control intraocular pressure in glaucomatous patients. It reduces IOP by creating a fistula between the anterior chamber and the subconjunctival space with a filtering bleb. Increased wound healing response affects the function and morphology of the filtering bleb, and wound healing involves a series of biological events beginning with hemostasis.

Corticosteroids and antifibrosis agents such as mitomycin C and 5-fluorouracil have been employed in trabeculectomy to delay wound healing and hence to improve the success rate of surgery by inhibiting inflammation and fibroblastic activity, and the use of these antiscarring agents is generally believed to improve the success rate of trabeculectomy.But this rate decreased with passing time and thus was not perfect.

Vascular endothelial growth factor is a pivotal stimulator of angiogenesis because its binding to VEGF receptors has been demonstrated to promote endothelial cell migration and proliferation in wound healing.Therefore, anti-VEGF agents may potentially modulate wound healing following glaucoma filtration surgery.

The principal objective of this study was to evaluate the additive effect of intracameral and subconjunctival injections of bevacizumab in trabeculectomy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • glaucoma patients who have trabeculectomy

排除标准

  • patients with the other ocular disease

研究组 & 干预措施

trabeculectomy

Other

Subjects who have trabeculectomies with intraocular bevacizumab injection

干预措施: intraocular injections of bevacizumab (Drug)

结局指标

主要结局

intraocular pressure

时间窗: on postoperative 1month

Intraocular pressure is planned to measure when the patient visit the clinic. All intraocular pressure measurements is acquired by glaucoma specialists, using a slitlamp-mounted Goldmann applanation tonometer.

次要结局

  • intraocular pressure(on postoperative 6months, 12months, 18months, 24months)

研究者

申办方类型
Other

研究点 (1)

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