Comparison of Single Intravitreal Injection of Triamcinolone or Bevacizumab for the Treatment of Diabetic Macular Edema (Tribeva-DME)

U

Universidade Federal de Goias

Status and phase

Completed
Phase 2

Conditions

Diabetic Macular Edema

Treatments

Drug: Bevacizumab
Drug: Triamcinolone acetonide

Study type

Interventional

Funder types

Other

Identifiers

NCT00874744
Cerof-001

Details and patient eligibility

About

The purpose of this study is to compare a single intravitreal injection of 4.0 mg of triamcinolone acetonide and 1.25 mg of bevacizumab for the treatment of diabetic macular edema.

Full description

Comparison a single intravitreal injection of 4.0 mg of triamcinolone acetonide and 1.25 mg of bevacizumab regarding the ability of central macular thickness reduction. Secondary objectives are analysis of Visual Outcomes and variations on Intraocular Pressure. The patients data were statistically analyzed if there was a 24 week follow up completed.

Enrollment

13 patients

Sex

All

Ages

40 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Diabetic macular edema with central foveal measurement over 300 micrometers

Exclusion criteria

  • Glaucoma
  • Vitreoretinal surgery
  • Cataract Surgery less than 3 months prior inclusion
  • Unilateral cataract surgery
  • Uncontrolled Glycosylated Hemoglobin
  • Previous Intraocular Injection
  • Systemic Corticosteroids less than 1 month prior inclusion
  • Macular ischemia at Fluorescein Angiography
  • Cataract precluding fundus examination
  • Active Proliferative Diabetic Retinopathy

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

13 participants in 2 patient groups

bevacizumab
Experimental group
Treatment:
Drug: Bevacizumab
Triamcinolone
Experimental group
Treatment:
Drug: Triamcinolone acetonide

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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