Comparison of Single Intravitreal Injection of Triamcinolone or Bevacizumab for the Treatment of Diabetic Macular Edema - Full Text View

Sponsored by:	Universidade Federal de Goias
Information provided by:	Universidade Federal de Goias
ClinicalTrials.gov Identifier:	NCT00874744

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 II

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Edema

Drug Information available for: Triamcinolone diacetate Triamcinolone acetonide Bevacizumab Triamcinolone Triamcinolone hexacetonide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Uncontrolled, Parallel Assignment, Efficacy Study
Official Title:	Phase 2 Study of Comparison of Single Intravitreal Injection of Triamcinolone or Bevacizumab for the Treatment of Diabetic Macular Edema.

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
bevacizumab: Experimental	Drug: Bevacizumab 1.25mg bevacizumab (0.05ml)
Triamcinolone: Experimental	Drug: Triamcinolone acetonide 4.0 mg Triamcinolone acetonide injection

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

Keywords provided by Universidade Federal de Goias:

Diabetic macular edema
intravitreal injection
Pharmacological treatment

Study placed in the following topic categories:

Anti-Inflammatory Agents
Immunologic Factors
Hormone Antagonists
Eye Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Edema
Macular Degeneration
Retinal Degeneration
Triamcinolone diacetate
Bevacizumab

Angiogenesis Inhibitors
Immunosuppressive Agents
Hormones
Glucocorticoids
Triamcinolone hexacetonide
Macular Edema
Signs and Symptoms
Triamcinolone Acetonide
Triamcinolone
Retinal Diseases

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Edema
Bevacizumab
Hormones
Triamcinolone hexacetonide
Signs and Symptoms
Macular Edema
Triamcinolone Acetonide
Therapeutic Uses

Triamcinolone
Growth Inhibitors
Angiogenesis Modulating Agents
Retinal Diseases
Growth Substances
Eye Diseases
Retinal Degeneration
Macular Degeneration
Triamcinolone diacetate
Enzyme Inhibitors
Glucocorticoids
Immunosuppressive Agents
Angiogenesis Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009