Intralesional Bevacizumab Injection on Primary Pterygium

Inflammation Clinical Trial

— bevacizumab  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01380678
• Other study ID #: KKU-1007
• Status: Recruiting
• Phase: Phase 3
• First received: June 14, 2010
• Last updated: July 7, 2011
• Start date: January 2009
• Est. completion date: December 2012

Study information

• Verified date: July 2010
• Source: Khon Kaen University
• Contact: Olan Suwan-apichon, MD
• Phone: +66 43 348383
• Email: osuwanapichon[@]hotmail.com
• Is FDA regulated: No
• Health authority: Thailand: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 206
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• primary pterygium

Exclusion Criteria:

• previous ocular surgery

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Inflammation
• Pterygium

Intervention

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
• Topical antihistamine and vasoconstrictor
combination of topical antazoline HCl 0.05% and tetrahydrozoline HCl 0.04%

Locations

Country	Name	City	State
Thailand	Srinagarind Hospital	Mueng	Khon Kaen

Sponsors (1)

Lead Sponsor	Collaborator
Khon Kaen University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentage of corneal pterygium area	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.	3 years	Yes