The Effect of Bevacizumab (Avastin) on Pterygium
Primary Purpose
Pterygium
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
local injection of bevacizumab
Sponsored by
About this trial
This is an interventional treatment trial for Pterygium
Eligibility Criteria
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.
Sites / Locations
- Callahan Eye Foundation Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Bevacizumab
Arm Description
Bevacizumab injection: 0.1ml, 6 monthly doses plus baseline and 1 week post baseline
Outcomes
Primary Outcome Measures
The Area the Pterygium Enlarged or Regressed as Measured From the Limbus Before and After Subconjunctival Bevacizumab Injection.
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
Number of Patients Having Surgical Removal of Pterygium.
The number of patients having surgical removal of pterygium within 12 months.
Full Information
NCT ID
NCT00592176
First Posted
December 26, 2007
Last Updated
May 20, 2014
Sponsor
University of Alabama at Birmingham
1. Study Identification
Unique Protocol Identification Number
NCT00592176
Brief Title
The Effect of Bevacizumab (Avastin) on Pterygium
Official Title
The Effect of Bevacizumab (Avastin) on Pterygium
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alabama at Birmingham
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pterygium
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bevacizumab
Arm Type
Experimental
Arm Description
Bevacizumab injection: 0.1ml, 6 monthly doses plus baseline and 1 week post baseline
Intervention Type
Drug
Intervention Name(s)
local injection of bevacizumab
Intervention Description
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.
Primary Outcome Measure Information:
Title
The Area the Pterygium Enlarged or Regressed as Measured From the Limbus Before and After Subconjunctival Bevacizumab Injection.
Description
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.
Time Frame
Baseline and 3 months
Secondary Outcome Measure Information:
Title
Number of Patients Having Surgical Removal of Pterygium.
Description
The number of patients having surgical removal of pterygium within 12 months.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tyler A Hall, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
Callahan Eye Foundation Hospital
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Effect of Bevacizumab (Avastin) on Pterygium
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