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Long-term Results After Intravitreal Bevacizumab Treatment Of Neovascular Age-related Macular Degeneration

Primary Purpose

Neovascular Age-related Macular Degeneration

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Bevacizumab
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neovascular Age-related Macular Degeneration focused on measuring bevacizumab, choroidal neovascularization

Eligibility Criteria

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

Inclusion Criteria:

  • any subtype of neovascular age-related macular degeneration
  • age of 50 years or older
  • initial treatment with intravitreal bevacizumab between August 2005 and June 2006

Exclusion Criteria:

  • previous vitrectomy
  • presence of cystoid macular edema without choroidal neovascularization
  • Uncontrolled systemic disease

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    group 1

    Arm Description

    bevacizumab intravitreal injection

    Outcomes

    Primary Outcome Measures

    Vision
    Best-corrected visual acuity converted to logMAR (MAR=minimum angle of resolution) for statistical analysis
    CRT (Central Retinal Thickness)
    Central retinal thickness measured in µm

    Secondary Outcome Measures

    Systemic Complications After Treatment

    Full Information

    First Posted
    December 7, 2009
    Last Updated
    April 3, 2019
    Sponsor
    Medical University of Vienna
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01027468
    Brief Title
    Long-term Results After Intravitreal Bevacizumab Treatment Of Neovascular Age-related Macular Degeneration
    Official Title
    Functional, Morphological And Safety Results After Intravitreal Bevacizumab Treatment Of Neovascular Age-related Macular Degeneration - 3 Years Of Follow-up
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2009 (undefined)
    Primary Completion Date
    November 2009 (Actual)
    Study Completion Date
    December 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Medical University of Vienna

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    200 eyes with each subtype of neovascular age-related macular degeneration will be included in this study and 3 years after the initial intravitreal bevacizumab, best-corrected visual acuity (BCVA) will be measured using Snellen charts at 6m. Central retinal thickness (CRT) will be measured using Stratus OCT and Cirrus SD-OCT (Zeiss). Data of treatment-naive eyes (group 1) were compared to the data of eyes that had undergone prior treatment with photodynamic therapy with verteporfin and intravitreal triamcinolone acetonide (group 2).
    Detailed Description
    In this interventional clinical study, 181 eyes of 160 consecutive patients with active neovascular related macular degeneration meeting recommended criteria for inclusion and protocol criteria for anti-vascular endothelial growth factor therapy undergoing intravitreal bevacizumab monotherapy were evaluated. Data of treatment-naive eyes (Group 1, n = 114) were analyzed separately from eyes that had undergone previous photodynamic therapy plus intravitreal triamcinolone (Group 2, n = 67). Re-treatment criteria were based on clinical outcome following the official European label regimen. After 1 year of continuous service at an academic referral center, follow-up was performed in private practices in collaboration with the referral center. Main outcome parameters were best-corrected visual acuity and central retinal thickness.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Neovascular Age-related Macular Degeneration
    Keywords
    bevacizumab, choroidal neovascularization

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    160 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    group 1
    Arm Type
    Experimental
    Arm Description
    bevacizumab intravitreal injection
    Intervention Type
    Drug
    Intervention Name(s)
    Bevacizumab
    Other Intervention Name(s)
    intraocular injection
    Intervention Description
    intraocular bevacizumab injection
    Primary Outcome Measure Information:
    Title
    Vision
    Description
    Best-corrected visual acuity converted to logMAR (MAR=minimum angle of resolution) for statistical analysis
    Time Frame
    3 years after first intravitreal bevacizumab treatment
    Title
    CRT (Central Retinal Thickness)
    Description
    Central retinal thickness measured in µm
    Time Frame
    3 years after initial intravitreal bevacizumab treatment
    Secondary Outcome Measure Information:
    Title
    Systemic Complications After Treatment
    Time Frame
    3 years after initial bevacizumab treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: any subtype of neovascular age-related macular degeneration age of 50 years or older initial treatment with intravitreal bevacizumab between August 2005 and June 2006 Exclusion Criteria: previous vitrectomy presence of cystoid macular edema without choroidal neovascularization Uncontrolled systemic disease
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Stefan Sacu, PD Dr.
    Organizational Affiliation
    Department of Ophthalmology, Medical University of Vienna, Austria
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Long-term Results After Intravitreal Bevacizumab Treatment Of Neovascular Age-related Macular Degeneration

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