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Completed

NCT Number: NCT01311960

Topical Bevacizumab for Preventing Recurrent Pterygium

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

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Key information

Conditions

Pterygium Anti-VEGF Bevacizumab Conjunctival Diseases Eye Diseases VEGF

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Faculty of medicine, Chulalongkorn university

Pathumwan, Bangkok, 10330, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

bevacizumab eye drop 0.05%

Drug

bevacizumab eye drop 0.05% will apply 4 times a day for 3 months

Other names: Study arm

normal saline 0.9%

Drug

normal saline eye drop 0.9% will apply 4 times a day for 3 months.

Other names: placebo arm

Primary outcomes

  1. rate of recurrence after primary pterygium removal

    Time frame: 3 months

Secondary outcomes

  1. Number of participants with adverse events as a measure of safety and tolerability

    Time frame: 3 months

    Local and systemic adverse events will be evaluated once a month. Number of participants with adverse events will be reported.

Sponsors and collaborators

Lead sponsor

Chulalongkorn University

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Mar 10, 2011
Registry last updated
Apr 9, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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