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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02310295
Recruitment Status : Completed
First Posted : December 8, 2014
Last Update Posted : December 8, 2014
Sponsor:
Information provided by (Responsible Party):
Andre Messias, University of Sao Paulo

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.

Condition or disease Intervention/treatment Phase
Diabetic Macular Edema Device: Laser Drug: Bevacizumab Drug: Triamcinolone Acetonide Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bevacizumabe e Acetato de Triancinolona Intra-vítreo Associados à Laserterapia em Pacientes Com Edema Macular diabético (IBeTA)
Study Start Date : January 2009
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arm Intervention/treatment
Active Comparator: IVB-Laser
Intravitreal Bevacizumab combined with focal laser therapy
Device: Laser
focal macular laser therapy

Drug: Bevacizumab
Intravitreal injection of Bevacizumab

Active Comparator: IVTA-Laser
Intravitreal Triamcinolone combined with focal laser therapy
Device: Laser
focal macular laser therapy

Drug: Triamcinolone Acetonide
Intravitreal injection of Triamcinolone Acetonide

Active Comparator: Laser
focal laser therapy
Device: Laser
focal macular laser therapy




Primary Outcome Measures :
  1. Central subfield macular thickness [ Time Frame: 12 months ]
    retinal thickness measured with optical coherence tomography

  2. Visual acuity [ Time Frame: 12 months ]
    Best corrected visual acuity



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
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Responsible Party: Andre Messias, PhD, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02310295    
Other Study ID Numbers: 12029-2008
First Posted: December 8, 2014    Key Record Dates
Last Update Posted: December 8, 2014
Last Verified: December 2014
Keywords provided by Andre Messias, University of Sao Paulo:
Diabetic retinopathy
Macular edema
Anti-VEGF
Triamcinolone
Additional relevant MeSH terms:
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Macular Edema
Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Bevacizumab
Triamcinolone diacetate
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action