Intravitreal Bevacizumab and Triamcinolone Associated to Laser Photocoagulation for Diabetic Macular Edema(IBeTA)

Sponsor
University of Sao Paulo
Study ID
NCT00997191
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Laser photocoagulation — PROCEDURE
    Focal / grid photocoagulation for diabetic macular edema according to ETDRS guidelines
  • Intravitreal triamcinolone — DRUG
    Intravitreal preservative-free triamcinolone (4mg) associated to focal photocoagulation for diabetic macular edema on baseline; Re-treatment at weeks 20 and 40 if CMT\>275um
  • Intravitreal bevacizumab — DRUG
    Intravitreal bevacizumab (1.5mg) associated to focal photocoagulation for diabetic macular edema at baseline; Re-treatment at weeks 20 and 40 if CMT\>275um

Study Details

Intravitreal triamcinolone has been effective for central macular thickness reduction and concomitant visual acuity improvement in patients with diabetic macular edema (DME). VEGF is a very effective inducer of permeability, being 50.000 times more potent than histamine, and may exert its effect on retinal vascular permeability by altering tight-junctions proteins, such as occluding and VE-cadherin. Based on these principles, there is a rationale for anti-VEGF agents treatment of increased retinal capillary permeability conditions, such as diabetic macular edema. Therefore, the purpose of this study is to evaluate the effects of intravitreal bevacizumab and intravitreal triamcinolone associated to laser photocoagulation for diabetic macular edema.

Key Dates

First listed
Oct 19, 2009
Start date
Oct 31, 2009
Status verified
Feb 2013
Primary completion
Nov 30, 2011
Completion
Nov 30, 2011

Study Design

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

Arms

  • Active Comparator: Laser Group
    Focal / grid Laser photocoagulation in diabetic macular edema
  • Experimental: Triamcinolone group
    Intravitreal triamcinolone associated to laser photocoagulation for diabetic macular edema
  • Experimental: Bevacizumab group
    Intravitreal Bevacizumab associated to laser photocoagulation for diabetic macular edema

Primary Outcome Measure

Best Corrected Visual acuity [ Time Frame: One Year ]

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