The Effect of Bevacizumab (Avastin) on Pterygium
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 Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Effect of Bevacizumab (Avastin) on Pterygium|
- The Area the Pterygium Enlarged or Regressed as Measured From the Limbus Before and After Subconjunctival Bevacizumab Injection. [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: No ]
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.
- Number of Patients Having Surgical Removal of Pterygium. [ Time Frame: 12 months ] [ Designated as safety issue: No ]The number of patients having surgical removal of pterygium within 12 months.
|Study Start Date:||August 2007|
|Study Completion Date:||March 2010|
|Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00592176
|United States, Alabama|
|Callahan Eye Foundation Hospital|
|Birmingham, Alabama, United States, 35233|
|Principal Investigator:||Tyler A Hall, MD||University of Alabama at Birmingham|