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临床试验/NCT01311960
NCT01311960已完成3 期

Topical Bevacizumab 0.05% Eye Drops for Preventing Recurrent Pterygium, A Randomized, Double-masked, Controlled Trial

Chulalongkorn University1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2010年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
24
试验地点
1
主要终点
rate of recurrence after primary pterygium removal

研究概览

简要总结

The purpose of this study is to determine whether bevacizumab eye drop is effective in the treatment of recurrent pterygium.

详细描述

A pterygium is a degenerative and proliferative fibrovascular disorder of the ocular surface. Patients may be asymptomatic, irritation, decreased vision, diplopia or limit ocular movement. The mainstay treatment is surgical removal of the head, neck and body of the pterygium. However, if there is no adjunctive treatment, the recurrence is unacceptably high which is 63% in general. Various adjunctive measures are applied to prevent recurrence including use of mitomycin C, beta-irradiation and surgical methods such as conjunctival and amniotic membrane graft. However, each method has its advantages and disadvantages.

The histologic finding of recurrent pterygium often has aggressive fibrovascular growth. Vascular endothelial growth factor(VEGF)has been detected in increased amounts in pterygium tissue, compared with normal conjunctiva and it is also correlated with post-operative recurrence. Bevacizumab, an Anti-VEGF, binds to VEGF and prevents the interaction of VEGF to its receptors on the surface of vascular endothelial cells. Administration of bevacizumab leads to inhibition of endothelial cell proliferation and new blood vessel formation. Even though there are reported the efficacy of topical bevacizumab in inhibiting the impending recurrent pterygium, there is no study for preventing recurrence after primary pterygium removal.

We conduct a prospective, randomized, double-masked, controlled trial to evaluate the efficacy of topical bevacizumab 0.05% eye drops for preventing recurrence in primary pterygium.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Investigator, Outcomes Assessor)

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

  • Patients who are diagnosed with primary pterygium and plan for pterygium excision with bare sclera by single surgeon. (G.N.)
  • Patients with pterygium who understand and can follow the study protocol.
  • Patients of age more than 30 years

排除标准

  • Patients who have corneal melt, corneal epitheliopathy, abnormal corneal epithelial wound healing.
  • Patients who are pregnancy or lactation.
  • Patients who have a history of allergy to bevacizumab.
  • Patients who have a history of allergy to steroid eye drops

研究组 & 干预措施

bevacizumab eye drop

Experimental

干预措施: bevacizumab eye drop 0.05% (Drug)

placebo normal saline eye drop

Experimental

干预措施: normal saline 0.9% (Drug)

结局指标

主要结局

rate of recurrence after primary pterygium removal

时间窗: 3 months

次要结局

  • Number of participants with adverse events as a measure of safety and tolerability(3 months)

研究者

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

Ngamjit Kasetsuwan

Associated professor

Chulalongkorn University

研究点 (1)

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