The Effect of Bevacizumab (Avastin) on Pterygium

NCT ID: NCT00592176

Last Updated: 2014-06-04

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2010-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pterygium

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bevacizumab

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

Group Type EXPERIMENTAL

local injection of bevacizumab

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tyler A Hall, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

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Callahan Eye Foundation Hospital

Birmingham, Alabama, United States

Site Status

Countries

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United States

Other Identifiers

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F070323011

Identifier Type: -

Identifier Source: org_study_id

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