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Sponsored by: |
University of Sao Paulo |
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Information provided by: | University of Sao Paulo |
ClinicalTrials.gov Identifier: | NCT00468351 |
Intravitreal triamcinolone has been effective for central macular thickness reduction and concomitant visual acuity improvement in patients with diabetic macular edema (DME). VEGF is a very effective inducer of permeability, being 50.000 times more potent than histamine, and may exert its effect on retinal vascular permeability by altering tight-junctions proteins, such as occluding and VE-cadherin. Based on these principles, there is a rationale for anti-VEGF agents treatment of increased retinal capillary permeability conditions, such as diabetic macular edema. Therefore, we conducted a randomized, prospective study to compare the efficacy and safety of intravitreal triamcinolone acetonide and intravitreal bevacizumab injection for refractory diffuse DME.
Condition | Intervention | Phase |
---|---|---|
Diabetic Macular Edema |
Procedure: Intravitreal Injection of 1,5 mg of bevacizumab Procedure: Intravitreal injection of 4 mg of Triamcinolone acetonide |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Intravitreal Bevacizumab Versus Intravitreal Triamcinolone Acetonide for Refractory Diabetic Macular Edema |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Brazil, São Paulo | |
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto | |
Ribeirão Preto, São Paulo, Brazil, 14049-900 |
Study Chair: | Rodrigo Jorge, MD, PhD | HCFMRP-USP |
Study Director: | Rogério A Costa, MD, PhD | Retina Diagnostic and Treatment Division, Hospital de Olhos de Araraquara, Araraquara |
Principal Investigator: | Rodrigo Jorge, MD, PhD | HCFMRP-USP |
Study ID Numbers: | 154342005 |
Study First Received: | May 1, 2007 |
Last Updated: | May 1, 2007 |
ClinicalTrials.gov Identifier: | NCT00468351 |
Health Authority: | Brazil: National Committee of Ethics in Research |
bevacizumab diabetes intravitreal |
macular edema triamcinolone VEGF |
Macular degeneration Eye Diseases Diabetes Mellitus Edema Macular Degeneration Retinal Degeneration Triamcinolone diacetate Bevacizumab |
Triamcinolone hexacetonide Macular Edema Signs and Symptoms Triamcinolone Acetonide Triamcinolone Retinal Diseases Retinal degeneration |
Anti-Inflammatory Agents Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Enzyme Inhibitors |
Glucocorticoids Hormones Immunosuppressive Agents Angiogenesis Inhibitors Pharmacologic Actions Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents |