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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00874744
Recruitment Status : Completed
First Posted : April 2, 2009
Last Update Posted : April 2, 2009
Sponsor:
Information provided by:
Universidade Federal de Goias

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Diabetic Macular Edema Drug: Bevacizumab Drug: Triamcinolone acetonide Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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.
Study Start Date : March 2008
Actual Primary Completion Date : September 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   40 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00874744


Sponsors and Collaborators
Universidade Federal de Goias
Investigators
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Principal Investigator: David LC Isaac, MD, PhD Universidade Federal de Goias
More Information
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Responsible Party: David Leonardo Cruvinel Isaac, MD, Federal University of Goiás
ClinicalTrials.gov Identifier: NCT00874744    
Other Study ID Numbers: Cerof-001
First Posted: April 2, 2009    Key Record Dates
Last Update Posted: April 2, 2009
Last Verified: March 2009
Keywords provided by Universidade Federal de Goias:
Diabetic macular edema
intravitreal injection
Pharmacological treatment
Additional relevant MeSH terms:
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Macular Edema
Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Bevacizumab
Triamcinolone diacetate
Antineoplastic Agents, Immunological
Antineoplastic Agents
 Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action