Topical Bevacizumab for Preventing Recurrent Pterygium

Phase 3

Completed

• Conditions: Pterygium; Bevacizumab; VEGF; Anti-VEGF
• Interventions: Drug: normal saline 0.9%; Drug: bevacizumab eye drop 0.05%

• Registration Number: NCT01311960
• Lead Sponsor: Chulalongkorn University

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2010-12-01
• Status Verified: 2011-03
• Study First Submitted QC: 2011-03-08
• Study First Posted: 2011-03-10
• Primary Completion: 2013-03
• Study Completion: 2013-04
• Last Update Submitted: 2013-04-06
• Last Update Posted: 2013-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo normal saline eye drop	normal saline 0.9%	-
bevacizumab eye drop	bevacizumab eye drop 0.05%	-

Primary Outcome Measures

Name	Time	Method
rate of recurrence after primary pterygium removal	3 months

Secondary Outcome Measures

Name	Time	Method
Number of participants with adverse events as a measure of safety and tolerability	3 months	Local and systemic adverse events will be evaluated once a month. Number of participants with adverse events will be reported.

Trial Locations

Locations (1)

Faculty of medicine, Chulalongkorn university; 🇹🇭 Pathumwan, Bangkok, Thailand