Safety and Efficacy of Triamcinolone Acetonide Combined With Laser, Bevacizumab Combined With Laser Versus Laser Alone for the Treatment of Diffuse Non-tractional Diabetic Macular Edema

Sponsor
Hospital Universitario de Canarias
Study ID
NCT01572350
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Grid laser — OTHER
    Grid laser therapy acts as the standard to refer to as it is the treatment which is currently accepted by EMDDNT.
  • Triamcinolone Acetonide — DRUG
    Triamcinolone 4 mg followed by modified grid laser therapy after 3-4 weeks
  • Bevacizumab — DRUG
    Bevacizumab (1.25 mg initially, weeks 6 and 12) followed by modified grid laser therapy after3-4 weeks

Study Details

This clinical trial is designed to investigate differences in terms of efficacy (mean change in best corrected visual acuity obtained after 12 months of treatment) and safety, of 3 therapeutic estrategies for non-tractional macular edema in diabetic patients: a) laser alone; b) laser plus tiramcinolon; and c) laser plus bevacizumab.

Key Dates

First listed
Apr 6, 2012
Start date
Oct 31, 2010
Status verified
Feb 2021
Primary completion
Dec 31, 2013
Completion
Dec 31, 2013

Study Design

Enrollment
105 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Grid laser
    It's a reference standard as the treatment which is currently accepted for NTDDME
  • Experimental: Triamcinolone 4 mg
  • Experimental: Bevacizumab

Primary Outcome Measure

Best-Corrected Visual Acuity (BCVA) [ Time Frame: 12 months ]

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