Role of Sub-Conjunctival Bevacizumab in Post Pterygium Excision Management

Phase 4

Completed

• Conditions: Pterygium
• Interventions: Drug: Bevacizumab

• Registration Number: NCT01736449
• Lead Sponsor: Arrowhead Regional Medical Center

Brief Summary

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.

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.

Study Timeline

• Study Start: 2011-04
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Status Verified: 2012-11
• Study First Submitted: 2012-11-21
• Study First Submitted QC: 2012-11-26
• Last Update Submitted: 2012-11-26
• Study First Posted: 2012-11-29
• Last Update Posted: 2012-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pterygium Excision with Bevacizumab Injection	Bevacizumab	-

Primary Outcome Measures

Name	Time	Method
number of recurrent pterygia with postoperative bevacizumab	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.

Trial Locations

Locations (1)

Arrowhead Regional Medical Center; 🇺🇸 Colton, California, United States