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

This study has been completed.
Sponsor:
Collaborator:
University of Bern
Information provided by:
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT00563940
First received: November 26, 2007
Last updated: September 5, 2011
Last verified: September 2011
History of Changes
  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:

MedlinePlus related topics: Edema
U.S. FDA Resources

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

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00563940     History of Changes
Other Study ID Numbers: AUG 044/07, KEK E: 29-03-07
Study First Received: November 26, 2007
Last Updated: September 5, 2011
Health Authority: Switzerland: Ethikkommission

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
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Bevacizumab
Anti-Inflammatory Agents
Therapeutic Uses
 Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 22, 2013