Topical Bevacizumab for Preventing Recurrent Pterygium

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

Detailed Description
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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.

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

Conditions
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Pterygium, Bevacizumab, VEGF, Anti-VEGF

Intervention / Treatment
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* Drug: bevacizumab eye drop 0.05%
* Drug: normal saline 0.9%


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: bevacizumab eye drop<br> | Drug: bevacizumab eye drop 0.05%<br>* bevacizumab eye drop 0.05% will apply 4 times a day for 3 months<br>* Other names: Study arm;|
| Experimental: placebo normal saline eye drop<br> | Drug: normal saline 0.9%<br>* normal saline eye drop 0.9% will apply 4 times a day for 3 months.<br>* Other names: placebo arm;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of recurrence after primary pterygium removal |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events as a measure of safety and tolerability | Local and systemic adverse events will be evaluated once a month. Number of participants with adverse events will be reported. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pterygium, recurrent pterygium, bevacizumab, VEGF, anti-VEGF