bevacizumab: Intralesional Bevacizumab Injection on Primary Pterygium

Sponsor

Khon Kaen University (Other)

Overall Status

Unknown status

CT.gov ID

NCT01380678

Collaborator

(none)

206

Enrollment

Location

Arms

Duration (Months)

4.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pterygium Inflammation	Drug: Intralesional injection of bevacizumab Drug: Topical antihistamine and vasoconstrictor	Phase 3

Detailed Description

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

206 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

Official Title:

A Randomized Controlled Trial of Intralesional Bevacizumab Injection on Primary Pterygium: Preliminary Results

Study Start Date :

Jan 1, 2009

Anticipated Primary Completion Date :

Dec 1, 2012

Anticipated Study Completion Date :

Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: bevacizumab intralesional bevacizumab injection	Drug: Intralesional injection of bevacizumab single dose of 2 mg of bevacizumab intralesional injection on pterygium Combination of topical antazoline and tetrahydrozoline four times a day Other Names: Avastin
Active Comparator: Topical antihistamine and vasoconstrictor combination of topical antazoline HCl 0.05% and tetrahydrozoline HCl 0.04%	Drug: Topical antihistamine and vasoconstrictor combination of topical antazoline HCl 0.05% and tetrahydrozoline HCl 0.04% Other Names: Hista-oph

Arm

Intervention/Treatment

Active Comparator: bevacizumab

intralesional bevacizumab injection

Drug: Intralesional injection of bevacizumab

single dose of 2 mg of bevacizumab intralesional injection on pterygium Combination of topical antazoline and tetrahydrozoline four times a day

Other Names:

Avastin

Active Comparator: Topical antihistamine and vasoconstrictor

combination of topical antazoline HCl 0.05% and tetrahydrozoline HCl 0.04%

Drug: Topical antihistamine and vasoconstrictor

combination of topical antazoline HCl 0.05% and tetrahydrozoline HCl 0.04%

Other Names:

Hista-oph

Outcome Measures

Primary Outcome Measures

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.