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Short-term Effects of Intravitreal Bevacizumab and Triamcinolone in Patients With Diabetic Macular Edema

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ClinicalTrials.gov Identifier: NCT00563940
Recruitment Status : Completed
First Posted : November 27, 2007
Last Update Posted : September 7, 2011
University of Bern
Information provided by:
University Hospital Inselspital, Berne

Brief Summary:
Diabetic macular edema is a common complication of ocular diabetes mellitus and can cause blindness. Hypoxygenation of the retina stimulates tissue mediators, especially different subtypes of vascular endothelial growth factor (VEGF). VEGF is responsible for proliferation, extension and increased permeability of the vessels. The aim of our study was to examine the short-term effect of intravitreal bevacizumab (Avastin® 1.25 mg in 0.05 ml) and triamcinolone on visual acuity and central retinal thickness in patients with clinically significant diabetic macular edema (CSME).

Condition or disease
Diabetic Macular Edema

Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Short-term Effects of Intravitreal Bevacizumab and Triamcinolone in Patients With Diabetic Macular Edema
Study Start Date : March 2007
Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema
U.S. FDA Resources


Primary Outcome Measures :
  1. Central retinal thickness [ Time Frame: 4, 8, 12, 24, 72, and 168 houres ]

Secondary Outcome Measures :
  1. BCVA [ Time Frame: 4, 8, 12, 24, 72, and 168 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with clinical significant macular edema

Inclusion Criteria:

  • clinical significant macular edema

Exclusion Criteria:

  • retinal thickness < 250 µm

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): NCT00563940

Klinik und Poliklinik für Augenheilkunde
Bern, Switzerland
Sponsors and Collaborators
University Hospital Inselspital, Berne
University of Bern
Principal Investigator: Ute Wolf-Schnurrbusch, MD University of Bern
Study Director: Sebastian Wolf, MD PhD University of Bern

ClinicalTrials.gov Identifier: NCT00563940     History of Changes
Other Study ID Numbers: AUG 044/07
KEK E: 29-03-07
First Posted: November 27, 2007    Key Record Dates
Last Update Posted: September 7, 2011
Last Verified: September 2011

Keywords provided by University Hospital Inselspital, Berne:
diabetic macular edema

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