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BRP: Subconjunctival Bevacizumab and Recurrent Pterygium

Sponsor
Instituto de Olhos de Goiania (Other)
Overall Status
Completed
CT.gov ID
NCT01744756
Collaborator
(none)
36
Enrollment
1
Location
1
Arm
7
Duration (Months)
5.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

Detailed Description

  1. Pacients with recurrent pterygium

  2. Anti-VEGF therapy -Bevacizumab

Study Design

Study Type:
Interventional
Actual Enrollment :
36 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Interventional Trial of Subconjunctival Bevacizumab in Recurrent Pterygium
Study Start Date :
Feb 1, 2012
Actual Primary Completion Date :
Jul 1, 2012
Actual Study Completion Date :
Sep 1, 2012

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pterygium size after subconjunctival bevacizumab [8 weeks]

      -Size of recurrent pterygium (measured in mm) after injection

    Secondary Outcome Measures

    1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [8 weeks]

      -Number of patients with hyposphagma and irritative symptoms after subconjunctival injection

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Recurrent pterygium
    Exclusion Criteria:

    • Pregnant or lactating women

    • History of myocardial infarction

    • History of stroke

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Instituto de Olhos de Goiania Goiania Goias Brazil 74110120

    Sponsors and Collaborators

    • Instituto de Olhos de Goiania

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Instituto de Olhos de Goiania
    ClinicalTrials.gov Identifier:
    NCT01744756
    Other Study ID Numbers:
    • pterygium bevacizumab
    First Posted:
    Dec 7, 2012
    Last Update Posted:
    Dec 7, 2012
    Last Verified:
    Dec 1, 2012
    Keywords provided by Instituto de Olhos de Goiania
    Subconjunctival Bevacizumab
    Recurrent pterygium
    Additional relevant MeSH terms:
    Pterygium
    Recurrence
    Bevacizumab

    Study Results

    No Results Posted as of Dec 7, 2012