The Effect of Bevacizumab (Avastin) on Pterygium

Pterygium Clinical Trial

Official title:

The Effect of Bevacizumab (Avastin) on Pterygium

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00592176
• Other study ID #: F070323011
• Status: Completed
• Phase: Phase 2
• First received: December 26, 2007
• Last updated: May 20, 2014
• Start date: August 2007
• Est. completion date: March 2010

Study information

• Verified date: May 2012
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pterygium

Intervention

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.

Locations

Country	Name	City	State
United States	Callahan Eye Foundation Hospital	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and 3 months	No
Secondary	Number of Patients Having Surgical Removal of Pterygium.	The number of patients having surgical removal of pterygium within 12 months.	12 months	No