The Effect of Bevacizumab (Avastin) on Pterygium

This study is currently recruiting participants.

Verified by University of Alabama at Birmingham, June 2008

First Received: December 26, 2007 Last Updated: June 3, 2008 History of Changes

Sponsored by:	University of Alabama at Birmingham
Information provided by:	University of Alabama at Birmingham
ClinicalTrials.gov Identifier:	NCT00592176

Purpose

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.

Condition	Intervention	Phase
Pterygium	Drug: local injection of bevacizumab	Phase II

MedlinePlus related topics: Surgery

Drug Information available for: Bevacizumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment
Official Title:	The Effect of Bevacizumab (Avastin) on Pterygium

Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:

To determine whether local injection of bevacizumab might halt and or cause regression of pterygium growth [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Limiting the need for surgery [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	25
Study Start Date:	August 2007
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Intervention Details:

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.

Eligibility

Ages Eligible for Study:	19 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00592176

Contacts

Contact: Tyler Hall, MD

205-325-8692

tahall@uab.edu

Locations

United States, Alabama
Callahan Eye Foundation Hospital	Recruiting
Birmingham, Alabama, United States, 35233
Contact: Tyler A Hall, MD 205-325-8692 tahall@uab.edu

Sponsors and Collaborators

University of Alabama at Birmingham

Investigators

Principal Investigator:

Tyler A Hall, MD

University of Alabama at Birmingham

More Information

No publications provided

Responsible Party:	University of Alabama at Birmingham ( Tyler A. Hall, MD )
Study ID Numbers:	F070323011
Study First Received:	December 26, 2007
Last Updated:	June 3, 2008
ClinicalTrials.gov Identifier:	NCT00592176 History of Changes
Health Authority:	United States: Food and Drug Administration; United States: Institutional Review Board

Study placed in the following topic categories:

Eye Diseases
Pterygium of the Conjunctiva
Bevacizumab

Angiogenesis Inhibitors
Pterygium
Conjunctival Diseases

Additional relevant MeSH terms:

Antineoplastic Agents
Therapeutic Uses
Growth Substances
Eye Diseases
Physiological Effects of Drugs
Growth Inhibitors

Angiogenesis Modulating Agents
Bevacizumab
Angiogenesis Inhibitors
Pterygium
Pharmacologic Actions
Conjunctival Diseases

ClinicalTrials.gov processed this record on May 07, 2009