The Effect of Bevacizumab (Avastin) on Pterygium

Phase 2

Completed

• Conditions: Pterygium
• Interventions: Drug: local injection of bevacizumab

• Registration Number: NCT00592176
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

The purpose of this study is to determine whether local injection of bevacizumab might halt and or cause regression of pterygium growth. This may enable earlier treatment and prevention of pterygium growth into the patient's line of sight thereby limiting the need for surgery and improving quality of life for patients with pterygia.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2007-12-26
• Study First Submitted QC: 2007-12-31
• Study First Posted: 2008-01-11
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Status Verified: 2012-05
• Results First Submitted: 2012-05-21
• Results First Submitted QC: 2012-05-21
• Results First Posted: 2012-06-25
• Last Update Submitted: 2014-05-20
• Last Update Posted: 2014-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

• 19 years of age and older
• Diagnosis of pterygia
• healthy enough to make scheduled follow-up visits

Exclusion Criteria

• Women of childbearing potential and males who plan to father a child during their participation in the study will be excluded from the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bevacizumab	local injection of bevacizumab	Bevacizumab injection: 0.1ml, 6 monthly doses plus baseline and 1 week post baseline

Primary Outcome Measures

Name	Time	Method
The Area the Pterygium Enlarged or Regressed as Measured From the Limbus Before and After Subconjunctival Bevacizumab Injection.	Baseline and 3 months	Growth of the pterygium was defined as an increase in the area of the pterygium as measured from the limbus toward the visual axis. This would be a positive change value indicating progression; Regression of the pterygium was defined as a decrease in the area of the pterygium length measured from the limbus toward the visual axis. This would be negative change value indicating regression.

Secondary Outcome Measures

Name	Time	Method
Number of Patients Having Surgical Removal of Pterygium.	12 months	The number of patients having surgical removal of pterygium within 12 months.

Trial Locations

Locations (1)

Callahan Eye Foundation Hospital; 🇺🇸 Birmingham, Alabama, United States