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Prospective, Randomized Clinical Trial Comparing Macular Photocoagulation With or Without Intravitreal Bevacizumab or Triamcinolone for the Treatment of Diabetic Macular Edema (IBeTA)

Primary Purpose

Diabetic Macular Edema

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Laser
Bevacizumab
Triamcinolone Acetonide
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Macular Edema focused on measuring Diabetic retinopathy, Macular edema, Anti-VEGF, Triamcinolone

Eligibility Criteria

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

Inclusion Criteria:

  1. clinically significant diabetic macular edema (DME) with diffuse leakage involving the center of the fovea, with DME greater than 275 microns in OCT examination
  2. BCVA between 0.3 LogMAR (logarithm of smaller angle of visual resolution) (20/40) and 1.6 LogMAR (20/800)
  3. signed of inform Consent.

Exclusion Criteria:

  1. HbA1c levels greater than 10%
  2. thromboembolic event history (including myocardial infarction and stroke)
  3. vitreo-macular traction on OCT
  4. coagulation disorders
  5. macular ischemia on fluorescein angiography examination
  6. proliferative diabetic retinopathy that required treatment
  7. eye surgery
  8. history of ocular hypertension or glaucoma
  9. any ocular pathology which in the opinion of the investigator, could macular edema or change the visual acuity during the study period (for example, retinal vascular occlusion, uveitis or other inflammatory eye disease, neovascular glaucoma)
  10. systemic corticosteroid therapy
  11. any conditions that could affect the documentation
  12. any previous treatment for diabetic macular edema.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    IVB-Laser

    IVTA-Laser

    Laser

    Arm Description

    Intravitreal Bevacizumab combined with focal laser therapy

    Intravitreal Triamcinolone combined with focal laser therapy

    focal laser therapy

    Outcomes

    Primary Outcome Measures

    Central subfield macular thickness
    retinal thickness measured with optical coherence tomography
    Visual acuity
    Best corrected visual acuity

    Secondary Outcome Measures

    Full Information

    First Posted
    December 2, 2014
    Last Updated
    December 5, 2014
    Sponsor
    University of Sao Paulo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02310295
    Brief Title
    Prospective, Randomized Clinical Trial Comparing Macular Photocoagulation With or Without Intravitreal Bevacizumab or Triamcinolone for the Treatment of Diabetic Macular Edema
    Acronym
    IBeTA
    Official Title
    Bevacizumabe e Acetato de Triancinolona Intra-vítreo Associados à Laserterapia em Pacientes Com Edema Macular diabético (IBeTA)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2009 (undefined)
    Primary Completion Date
    December 2011 (Actual)
    Study Completion Date
    December 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Sao Paulo

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Purpose: To compare the effects of macular photocoagulation with or without intravitreal bevacizumab (IVB) or triamcinolone (IVTA) for the treatment of diabetic macular edema (DME). Casuistic and Methods: 58 eyes of 44 patients with diffuse DME were randomized to receive either IVB + focal/grid laser (IVB-Laser, n=19), IVTA + focal/grid laser (IVTA-Laser, n=16) or focal/grid laser alone (Laser, n=23). Ophthalmic evaluation, including best-corrected visual acuity (BCVA), intraocular pressure (IOP) and central macular thickness (CMT) were performed at baseline and monthly for 12 months.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetic Macular Edema
    Keywords
    Diabetic retinopathy, Macular edema, Anti-VEGF, Triamcinolone

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    45 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    IVB-Laser
    Arm Type
    Active Comparator
    Arm Description
    Intravitreal Bevacizumab combined with focal laser therapy
    Arm Title
    IVTA-Laser
    Arm Type
    Active Comparator
    Arm Description
    Intravitreal Triamcinolone combined with focal laser therapy
    Arm Title
    Laser
    Arm Type
    Active Comparator
    Arm Description
    focal laser therapy
    Intervention Type
    Device
    Intervention Name(s)
    Laser
    Intervention Description
    focal macular laser therapy
    Intervention Type
    Drug
    Intervention Name(s)
    Bevacizumab
    Intervention Description
    Intravitreal injection of Bevacizumab
    Intervention Type
    Drug
    Intervention Name(s)
    Triamcinolone Acetonide
    Intervention Description
    Intravitreal injection of Triamcinolone Acetonide
    Primary Outcome Measure Information:
    Title
    Central subfield macular thickness
    Description
    retinal thickness measured with optical coherence tomography
    Time Frame
    12 months
    Title
    Visual acuity
    Description
    Best corrected visual acuity
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: clinically significant diabetic macular edema (DME) with diffuse leakage involving the center of the fovea, with DME greater than 275 microns in OCT examination BCVA between 0.3 LogMAR (logarithm of smaller angle of visual resolution) (20/40) and 1.6 LogMAR (20/800) signed of inform Consent. Exclusion Criteria: HbA1c levels greater than 10% thromboembolic event history (including myocardial infarction and stroke) vitreo-macular traction on OCT coagulation disorders macular ischemia on fluorescein angiography examination proliferative diabetic retinopathy that required treatment eye surgery history of ocular hypertension or glaucoma any ocular pathology which in the opinion of the investigator, could macular edema or change the visual acuity during the study period (for example, retinal vascular occlusion, uveitis or other inflammatory eye disease, neovascular glaucoma) systemic corticosteroid therapy any conditions that could affect the documentation any previous treatment for diabetic macular edema.

    12. IPD Sharing Statement

    Learn more about this trial

    Prospective, Randomized Clinical Trial Comparing Macular Photocoagulation With or Without Intravitreal Bevacizumab or Triamcinolone for the Treatment of Diabetic Macular Edema

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