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The Effect of Bevacizumab on Corneal Neovascularization (BQ-1-08-ARVO)

Primary Purpose

Corneal Neovascularization

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Bevacizumab
Sponsored by
Instituto de Olhos de Goiania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Corneal Neovascularization focused on measuring bevacizumab, cornea, neovascularization

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Corneal Neovascularization
  • Stable lesion

Exclusion Criteria:

  • Diabetes
  • Autoimmune diseases

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    1

    Arm Description

    A single intraoperative subconjunctival application of bevacizumab and 2 months follow-up

    Outcomes

    Primary Outcome Measures

    The Effect of Bevacizumab on Corneal Neovascularization
    Eight patients with corneal neovascularization were treated with subconjunctival injection of 1.25 mg bevacizumab and had a follow-up of at least 2 months. All patients had persistent corneal neovascularization for at least 6 months unresponsive to other treatments. Patients were monitored by ophthalmic exam and anterior segment photography

    Secondary Outcome Measures

    Full Information

    First Posted
    November 22, 2008
    Last Updated
    December 1, 2011
    Sponsor
    Instituto de Olhos de Goiania
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00797303
    Brief Title
    The Effect of Bevacizumab on Corneal Neovascularization
    Acronym
    BQ-1-08-ARVO
    Official Title
    The Effect of Bevacizumab on Corneal Neovascularization
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2006 (undefined)
    Primary Completion Date
    July 2008 (Actual)
    Study Completion Date
    November 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Instituto de Olhos de Goiania

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Eight patients with corneal neovascularization were treated with subconjunctival injection of 1.25 mg bevacizumab and had a follow-up of at least 2 months. All patients had persistent corneal neovascularization for at least 6 months unresponsive to other treatments. Patients were monitored by ophthalmic exam and anterior segment photography.
    Detailed Description
    To evaluate the effect of repeated subconjunctival bevacizumab (Avastin®, Roche, Rio de Janeiro, Brazil) on inflammatory corneal neovascularization. Eight patients with corneal neovascularization were treated with subconjunctival injection of 1.25 mg bevacizumab and had a follow-up of at least 2 months. All patients had persistent corneal neovascularization for at least 6 months unresponsive to other treatments. Patients were monitored by ophthalmic exam and anterior segment photography.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Corneal Neovascularization
    Keywords
    bevacizumab, cornea, neovascularization

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    Investigator
    Allocation
    N/A
    Enrollment
    8 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    A single intraoperative subconjunctival application of bevacizumab and 2 months follow-up
    Intervention Type
    Drug
    Intervention Name(s)
    Bevacizumab
    Intervention Description
    subconjunctival injection of 1.25 mg bevacizumab and had a follow-up of at least 2 months
    Primary Outcome Measure Information:
    Title
    The Effect of Bevacizumab on Corneal Neovascularization
    Description
    Eight patients with corneal neovascularization were treated with subconjunctival injection of 1.25 mg bevacizumab and had a follow-up of at least 2 months. All patients had persistent corneal neovascularization for at least 6 months unresponsive to other treatments. Patients were monitored by ophthalmic exam and anterior segment photography
    Time Frame
    Compare the results

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Corneal Neovascularization Stable lesion Exclusion Criteria: Diabetes Autoimmune diseases
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Belquiz A Nassaralla, PhD
    Organizational Affiliation
    Instituto de Olhos de Goiânia
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    The Effect of Bevacizumab on Corneal Neovascularization

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