The Effect of Bevacizumab (Avastin) on Pterygium

May 20, 2014 updated by: University of Alabama at Birmingham
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Callahan Eye Foundation Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bevacizumab
Bevacizumab injection: 0.1ml, 6 monthly doses plus baseline and 1 week post baseline
Drug: local injection of bevacizumab
Upon enrollment into the study: - initial injection of bevacizumab, a 1 week post-injection visit,and monthly visits thereafter for a total of 6 months. At the 1-month and 3-month visit post-injection visit, an additional bevacizumab injection will be offered if pterygium regression has not occurred. All injections of bevacizumab will consist of injecting 0.1mL of a 2.5mg/0.1mL concentration of bevacizumab into the head of the pterygium.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Area the Pterygium Enlarged or Regressed as Measured From the Limbus Before and After Subconjunctival Bevacizumab Injection.
Time Frame: 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.
Baseline and 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients Having Surgical Removal of Pterygium.
Time Frame: 12 months
The number of patients having surgical removal of pterygium within 12 months.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Investigators

  • Principal Investigator: Tyler A Hall, MD, University of Alabama at Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

December 26, 2007

First Submitted That Met QC Criteria

December 31, 2007

First Posted (Estimate)

January 11, 2008

Study Record Updates

Last Update Posted (Estimate)

June 4, 2014

Last Update Submitted That Met QC Criteria

May 20, 2014

Last Verified

May 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F070323011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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