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

Sponsor
University Hospital Inselspital, Berne (Other)
Overall Status
Completed
CT.gov ID
NCT00563940
Collaborator
University of Bern (Other)
30
Enrollment
1
Location
35.1
Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    Study Design

    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 :
    Mar 1, 2007
    Actual Primary Completion Date :
    Feb 1, 2010
    Actual Study Completion Date :
    Feb 1, 2010

    Arms and Interventions

    Arm Intervention/Treatment
    1
    2

    Outcome Measures

    Primary Outcome Measures

    1. Central retinal thickness [4, 8, 12, 24, 72, and 168 hours]

    Secondary Outcome Measures

    1. BCVA [4, 8, 12, 24, 72, and 168 hours]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • clinical significant macular edema
    Exclusion Criteria:
    • retinal thickness < 250 µm

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital Inselspital, Berne
    ClinicalTrials.gov Identifier:
    NCT00563940
    Other Study ID Numbers:
    • AUG 044/07
    • KEK E: 29-03-07
    First Posted:
    Nov 27, 2007
    Last Update Posted:
    Jul 8, 2019
    Last Verified:
    Jul 1, 2019
    Keywords provided by University Hospital Inselspital, Berne
    diabetic macular edema
    OCT
    Additional relevant MeSH terms:
    Macular Edema
    Edema

    Study Results

    No Results Posted as of Jul 8, 2019