Topical Bevacizumab for Preventing Recurrent Pterygium

Pterygium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01311960
• Other study ID #: IRB No. 227/53
• Status: Completed
• Phase: Phase 3
• First received: December 1, 2010
• Last updated: April 6, 2013
• Start date: December 2010
• Est. completion date: April 2013

Study information

• Verified date: March 2011
• Source: Chulalongkorn University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anti-VEGF
• Bevacizumab
• Pterygium
• VEGF

Intervention

Drug:
• bevacizumab eye drop 0.05%
bevacizumab eye drop 0.05% will apply 4 times a day for 3 months
• normal saline 0.9%
normal saline eye drop 0.9% will apply 4 times a day for 3 months.

Locations

Country	Name	City	State
Thailand	Faculty of medicine, Chulalongkorn university	Pathumwan	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of recurrence after primary pterygium removal		3 months	Yes
Secondary	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	Yes