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

Sponsor
University of Sao Paulo
Study ID
NCT02310295
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Laser — DEVICE
    focal macular laser therapy
  • Bevacizumab — DRUG
    Intravitreal injection of Bevacizumab
  • Triamcinolone Acetonide — DRUG
    Intravitreal injection of Triamcinolone Acetonide

Study Details

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.

Key Dates

First listed
Dec 8, 2014
Start date
Jan 31, 2009
Status verified
Dec 2014
Primary completion
Dec 31, 2011
Completion
Dec 31, 2012

Study Design

Enrollment
45 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: IVB-Laser
    Intravitreal Bevacizumab combined with focal laser therapy
  • Active Comparator: IVTA-Laser
    Intravitreal Triamcinolone combined with focal laser therapy
  • Active Comparator: Laser
    focal laser therapy

Primary Outcome Measure

Central subfield macular thickness [ Time Frame: 12 months ]

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