Role of Sub-Conjunctival Bevacizumab in Post Pterygium Excision Management

Overview

A pterygium is a fibrovascular growth originating from the conjunctiva that grows onto the surface of the cornea. Frequently, these pterygia will recur even after surgical resection. Bevacizumab is an inhibitor of angiogenesis, which is needed for recurrent growth. The use of bevacizumab is poorly understood in inhibiting pterygium growth. The objective of this study is to compare the effects of wound healing and recurrence rates in postoperative bevacizumab versus pterygium excision alone.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2012

Detailed Description

This is a prospective trial. Thirty-one patients with a primary pterygium of at least 2 mm in size and without any previous ocular surgery will be included. Outcome measures will include best corrected visual acuity, intraocular pressure, recurrence, and any sight threatening complications at two weeks, two months, and six months postoperatively.

Interventions

  • Drug: Bevacizumab

Arms, Groups and Cohorts

  • Placebo Comparator: Pterygium Excision Alone
  • Experimental: Pterygium Excision with Bevacizumab Injection

Clinical Trial Outcome Measures

Primary Measures

  • number of recurrent pterygia with postoperative bevacizumab
    • Time Frame: 6 months
    • The number of recurrent pterygia with patients who received bevacizumab after pterygium excision was compared to the number of recurrences in those patients who only had pterygium excision.

Participating in This Clinical Trial

Inclusion Criteria

  • any patient 18 years of age or older with a primary pterygium that extends at least 2 mm past the limbus Exclusion Criteria:

  • history of glaucoma – previous ocular surgery – steroid-response glaucoma – previous myocardial infarct – bleeding disorder – pregnancy – lack of patient cooperation

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Investigator Details

  • Lead Sponsor
    • Arrowhead Regional Medical Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Sonia Dhoot, Prinicipal Investigator – Arrowhead Regional Medical Center
  • Overall Official(s)
    • Keith Tokuhara, MD, Principal Investigator, Arrowhead Regional Medical Center

References

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