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.

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Key information

Conditions

Pterygium Conjunctival Diseases Eye Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Callahan Eye Foundation Hospital

Birmingham, Alabama, 35233, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

The Area the Pterygium Enlarged or Regressed as Measured From the Limbus Before and After Subconjunctival Bevacizumab Injection.

Time frame: Baseline and 3 months

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 outcomes

Number of Patients Having Surgical Removal of Pterygium.

Time frame: 12 months

The number of patients having surgical removal of pterygium within 12 months.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Important dates

Study start: 2007
Primary completion: 2010
Study completion: 2010
First posted: Jan 11, 2008
Registry last updated: Jun 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed