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

This study has been completed.
Sponsor:
Information provided by:
Universidade Federal de Goias
ClinicalTrials.gov Identifier:
NCT00874744
First received: March 31, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Diabetic Macular Edema
 Drug: Bevacizumab
Drug: Triamcinolone acetonide
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Phase 2 Study of Comparison of Single Intravitreal Injection of Triamcinolone or Bevacizumab for the Treatment of Diabetic Macular Edema.

Resource links provided by NLM:

MedlinePlus related topics: Edema
U.S. FDA Resources

Further study details as provided by Universidade Federal de Goias:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 13
Study Start Date: March 2008
Study Completion Date: October 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: bevacizumab Drug: Bevacizumab
1.25mg bevacizumab (0.05ml)
Other Names:
  • 1.Bevacizumab
  • 2.Avastin
Experimental: Triamcinolone Drug: Triamcinolone acetonide
4.0 mg Triamcinolone acetonide injection
Other Names:
  • 1. Theracort
  • 2. Kenalog

Detailed 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.

  Eligibility

Ages Eligible for Study:   40 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00874744

Sponsors and Collaborators
Universidade Federal de Goias
Investigators
Principal Investigator: David LC Isaac, MD, PhD Universidade Federal de Goias
  More Information

No publications provided

Responsible Party: David Leonardo Cruvinel Isaac, MD, Federal University of Goiás
ClinicalTrials.gov Identifier: NCT00874744     History of Changes
Other Study ID Numbers: Cerof-001
Study First Received: March 31, 2009
Last Updated: March 31, 2009
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Universidade Federal de Goias:
Diabetic macular edema
intravitreal injection
Pharmacological treatment

Additional relevant MeSH terms:
Edema
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Bevacizumab
Anti-Inflammatory Agents
Therapeutic Uses
 Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 19, 2013