Efficacy Study of Triamcinolone and Bevacizumab Intravitreal for Treatment of Diabetic Macular Edema

Sponsor
Rubens Belfort Jr.
Study ID
NCT00737971
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Bevacizumab intravitreal — DRUG
    Bevacizumab intravitreal 0.05 ml/1.25 mg - administered on D0, Week 4, Week 8
  • Triamcinolone — DRUG
    Intravitreal 0.1 ml/4 mg, D0, Week 4 and Week 8
  • Triamcinolone + Bevacizumab — DRUG
    Intravitreal triamcinolone 0.1 ml/4 mg + bevacizumab 0.05 ml/1.25 mg simultaneously on D0, week 4, Week 8

Study Details

Triamcinolone and Bevacizumab Intravitreal for Treatment of Diabetic Macular Edema

Key Dates

First listed
Aug 20, 2008
Start date
Aug 31, 2008
Status verified
Apr 2016
Primary completion
Dec 31, 2012
Completion
Dec 31, 2013

Study Design

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

Arms

  • Active Comparator: A
    Avastin intravitreal injection D0, Week 4, Week 8
  • Active Comparator: B
    Triamcinolone intravitreal injection
  • Active Comparator: C
    Avastin + Triamcinolone intravitreal injection simultaneously

Primary Outcome Measure

Measurement of visual acuity (E Snellen) [ Time Frame: monthly ]

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