Subconjunctival Bevacizumab and Recurrent Pterygium (BRP)

December 6, 2012 updated by: Instituto de Olhos de Goiania

Interventional Trial of Subconjunctival Bevacizumab in Recurrent Pterygium

A study to research whether subconjunctival bevacizumab injection may potentially suppress neovascularization in pterygium, retarding and decreasing the size of recurrent pterygium.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  1. Pacients with recurrent pterygium
  2. Anti-VEGF therapy -Bevacizumab

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Goias
      • Goiania, Goias, Brazil, 74110120
        • Instituto de Olhos de Goiania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Recurrent pterygium

Exclusion Criteria:

  • Pregnant or lactating women
  • History of myocardial infarction
  • History of stroke

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Subconjunctival Bevacizumab
One aplication of subconjunctival Bevacizumab 0,5 ml
Drug: Bevacizumab
One subconjunctival aplication of Bevacizumabe 0,5ml
Other Names:
  • Avastin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pterygium size after subconjunctival bevacizumab
Time Frame: 8 weeks
-Size of recurrent pterygium (measured in mm) after injection
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame: 8 weeks
-Number of patients with hyposphagma and irritative symptoms after subconjunctival injection
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto de Olhos de Goiania

Investigators

  • Study Chair: Larissa S Stival, MD, Instituto de Olhos de Goiania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

November 29, 2012

First Submitted That Met QC Criteria

December 6, 2012

First Posted (Estimate)

December 7, 2012

Study Record Updates

Last Update Posted (Estimate)

December 7, 2012

Last Update Submitted That Met QC Criteria

December 6, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • pterygium bevacizumab

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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