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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00563940
First Posted: November 27, 2007
Last Update Posted: September 7, 2011
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.
Collaborator:
University of Bern
Information provided by:
University Hospital Inselspital, Berne
  Purpose
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
Diabetic Macular Edema

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Short-term Effects of Intravitreal Bevacizumab and Triamcinolone in Patients With Diabetic Macular Edema

Resource links provided by NLM:


Further study details as provided by University Hospital Inselspital, Berne:

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

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

Enrollment: 30
Study Start Date: March 2007
Study Completion Date: February 2010

  Eligibility

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
Criteria

Inclusion Criteria:

  • clinical significant macular edema

Exclusion Criteria:

  • retinal thickness < 250 µm
  Contacts and Locations
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


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

ClinicalTrials.gov Identifier: NCT00563940     History of Changes
Other Study ID Numbers: AUG 044/07
KEK E: 29-03-07
First Submitted: November 26, 2007
First Posted: November 27, 2007
Last Update Posted: September 7, 2011
Last Verified: September 2011

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

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