The Effect of Bevacizumab (Avastin) on Pterygium

NCT00592176 | Completed Phase 2 Results

• 1 other identifier: F070323011
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Pterygium

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Number of Patients Having Surgical Removal of Pterygium.

  12 months

Study Arms (1)

Bevacizumab

EXPERIMENTAL

Bevacizumab injection: 0.1ml, 6 monthly doses plus baseline and 1 week post baseline

Drug: local injection of bevacizumab

Interventions

local injection of bevacizumab DRUG

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.

Bevacizumab

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

Callahan Eye Foundation Hospital

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Pterygium

Condition Hierarchy (Ancestors)

Conjunctival Diseases; Eye Diseases

Limitations and Caveats

Initially we aimed for 10 to 15 subjects but only enrolled 5 subjects.

Results Point of Contact

• Title: Dr. Tyler Hall, M.D.
• Organization: University of Alabama at Birmingham

tandrewhall@yahoo.com

205-325-8310

Study Officials

• Tyler A Hall, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2007
• First Posted: January 11, 2008
• Study Start: August 1, 2007
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: June 4, 2014
• Results First Posted: June 25, 2012

Record last verified: 2012-05

Locations

US (1)