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Combined Triple Procedure in Retinal Vein Occlusion (RVO)

Primary Purpose

Retinal Vein Occlusion

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
triamcinolone and bevacizumab
Sponsored by
Johann Wolfgang Goethe University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Retinal Vein Occlusion

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Ischemic central RVO (CRVO)
  • Non-ischemic CRVO
  • Branch RVO (BRVO)

Exclusion Criteria:

  • Visual deterioration due to acute or chronic inflammation
  • Post trauma
  • Macular edema of other origin
  • Intravitreal drug treatment within last 4 months

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    ischemic CRVO

    non ischemic CRVO

    BRVO

    Arm Description

    treatment was applied to this entity

    treatment was applied to this entity

    treatment was applied to this entity

    Outcomes

    Primary Outcome Measures

    BCVA

    Secondary Outcome Measures

    Full Information

    First Posted
    December 4, 2008
    Last Updated
    September 26, 2012
    Sponsor
    Johann Wolfgang Goethe University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00805064
    Brief Title
    Combined Triple Procedure in Retinal Vein Occlusion (RVO)
    Official Title
    Intravitreal Combination Therapy Using Triamcinolone and Bevacizumab Improves Vision in Patients With Retinal Vein Occlusion
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2006 (undefined)
    Primary Completion Date
    December 2007 (Actual)
    Study Completion Date
    November 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Johann Wolfgang Goethe University Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The aim of this pilot study was to investigate the effects of an intravitreal combination therapy using triamcinolone and bevacizumab in patients with retinal vein occlusion (RVO).
    Detailed Description
    This prospective study of a case series was conducted in 47 patients (n = 47 eyes; f/m: 21/26; mean age: 66.6 years) with ischemic central RVO (CRVO) (n = 15), non-ischemic CRVO (n = 7), or branch RVO (BRVO) (n = 25). A core pars plana vitrectomy with aspiration of 1.5 ml vitreous and infusion of balanced salt solution (BSS; 1 ml), 8 mg (0.4 ml) triamcinolone, and 1.25 mg (0.1 ml) bevacizumab was performed with a single sutureless sclerotomy and a 23 gauge probe tip. At baseline and follow-up, the best corrected visual acuity (BCVA; 6 m Snellen), and intraocular pressure (IOP; Goldmann tonometry), and central macular thickness (optical coherence tomography) were determined. In addition, the need for further treatment and adverse events were monitored.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Retinal Vein Occlusion

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    ischemic CRVO
    Arm Type
    Active Comparator
    Arm Description
    treatment was applied to this entity
    Arm Title
    non ischemic CRVO
    Arm Type
    Active Comparator
    Arm Description
    treatment was applied to this entity
    Arm Title
    BRVO
    Arm Type
    Active Comparator
    Arm Description
    treatment was applied to this entity
    Intervention Type
    Drug
    Intervention Name(s)
    triamcinolone and bevacizumab
    Primary Outcome Measure Information:
    Title
    BCVA
    Time Frame
    day of exam

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Ischemic central RVO (CRVO) Non-ischemic CRVO Branch RVO (BRVO) Exclusion Criteria: Visual deterioration due to acute or chronic inflammation Post trauma Macular edema of other origin Intravitreal drug treatment within last 4 months
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Michael Koss, MD
    Organizational Affiliation
    Department of VitreoRetinal Surgery ZAU JWGU
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Combined Triple Procedure in Retinal Vein Occlusion (RVO)

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