Intralesional Bevacizumab Injection on Primary Pterygium

Phase 3

• Conditions: Pterygium; Inflammation
• Interventions: Drug: Intralesional injection of bevacizumab; Drug: Topical antihistamine and vasoconstrictor

• Registration Number: NCT01380678
• Lead Sponsor: Khon Kaen University

Brief Summary

The purpose of this study is to evaluate that intralesional injection of bevacizumab on primary pterygium can reduce the corneal pterygium area, inflammation, redness and other symptoms.

Detailed Description

To evaluate the efficacy and safety of intralesional injection of bevacizumab on primary pterygium treatment

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2010-06-14
• Status Verified: 2010-07
• Study First Submitted QC: 2011-06-23
• Study First Posted: 2011-06-27
• Last Update Submitted: 2011-07-07
• Last Update Posted: 2011-07-11
• Primary Completion: 2012-12
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 206

Inclusion Criteria

• primary pterygium

Exclusion Criteria

• previous ocular surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
bevacizumab	Intralesional injection of bevacizumab	intralesional bevacizumab injection
Topical antihistamine and vasoconstrictor	Topical antihistamine and vasoconstrictor	combination of topical antazoline HCl 0.05% and tetrahydrozoline HCl 0.04%

Primary Outcome Measures

Name	Time	Method
percentage of corneal pterygium area	3 years	Prior to receive the treatments, patients were asked to evaluate grading of their own symptoms and underwent clinical grading of the elevation and inflammation of the lesions using slit lamp biomicroscopy by an opthalmologist (OE). Digital photographs of each eye with pterygium were obtained for corneal pterygium area analysis \[Sony Mavica digital still camera MVC-FD83, Japan\]. Each patient was randomly assigned into either treatment group or control group using computer-generated random numbers table.; Number of patients with adverse events will be recorded.

Trial Locations

Locations (1)

Srinagarind Hospital; 🇹🇭 Mueng, Khon Kaen, Thailand