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Completed

NCT Number: NCT00874744

Comparison of Single Intravitreal Injection of Triamcinolone or Bevacizumab for the Treatment of Diabetic Macular Edema

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.

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Key information

Conditions

Diabetic Macular Edema

Age range

40 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bevacizumab

Drug

1.25mg bevacizumab (0.05ml)

Other names: 1.Bevacizumab, 2.Avastin

Triamcinolone Acetonide

Drug

4.0 mg Triamcinolone acetonide injection

Other names: 1. Theracort, 2. Kenalog

Primary outcomes

  1. Comparison between the efficacy of a single intravitreal injection of 4.0mg of triamcinolone acetonide or 1.25mg of bevacizumab in the treatment of diabetic macular edema

    Time frame: 6 months

Secondary outcomes

  1. To compare Visual Acuity between the same drug in Initial visit, 4, 12 ans 24 weeks and Visual Acuity between two group of eyes treated with different drugs.

    Time frame: 6 months

  2. To compare Intraocular Pressure between the same drug in Initial visit, 4, 12 ans 24 weeks and Intraocular Pressure between two group of eyes treated with different drugs.

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Universidade Federal de Goias

Other

Registry information

Official study title

Phase 2 Study of Comparison of Single Intravitreal Injection of Triamcinolone or Bevacizumab for the Treatment of Diabetic Macular Edema.

Acronym: Tribeva-DME

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Apr 2, 2009
Registry last updated
Apr 2, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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