Topical Bevacizumab for Preventing Recurrent Pterygium

NCT ID: NCT01311960

Last Updated: 2013-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2013-04-30

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.

Conditions

Pterygium; Bevacizumab; VEGF; Anti-VEGF

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

bevacizumab eye drop

Group Type: EXPERIMENTAL

bevacizumab eye drop 0.05%

Intervention Type: DRUG

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

placebo normal saline eye drop

Group Type: EXPERIMENTAL

normal saline 0.9%

Intervention Type: DRUG

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

Interventions

bevacizumab eye drop 0.05%

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

Intervention Type: DRUG

normal saline 0.9%

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

Intervention Type: DRUG

Other Intervention Names

Study arm; placebo arm

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chulalongkorn University

OTHER

Sponsor Role: lead

Responsible Party

Ngamjit Kasetsuwan

Associated professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ngamjit Kasetsuwan, MD

Role: PRINCIPAL_INVESTIGATOR

Chulalongkorn Universitiy

Locations

Faculty of medicine, Chulalongkorn university

Pathumwan, Bangkok, Thailand

Countries

Thailand

References

Kasetsuwan N, Reinprayoon U, Satitpitakul V. Prevention of recurrent pterygium with topical bevacizumab 0.05% eye drops: a randomized controlled trial. Clin Ther. 2015 Oct 1;37(10):2347-51. doi: 10.1016/j.clinthera.2015.08.023. Epub 2015 Sep 26.

Reference Type: DERIVED

PMID: 26409291 (View on PubMed)

Other Identifiers

IRB No. 227/53

Identifier Type: -

Identifier Source: org_study_id