Clincosm LogoSign in Get a demo

A Long-Term Safety Study of OZURDEX® in Clinical Practice

Sponsor
Allergan (Industry)
Overall Status
Completed
CT.gov ID
NCT01539577
Collaborator
(none)
875
Enrollment
4
Locations
48
Duration (Months)
218.8
Patients Per Site
4.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is a multicenter, prospective, observational study to evaluate the long-term safety of OZURDEX® in patients with macular oedema following central retinal vein occlusion (CRVO) or branch retinal vein occlusion (BRVO) or patients with non-infectious posterior segment uveitis in real-world clinical practice.

Condition or Disease Intervention/Treatment Phase
  • Drug: dexamethasone 700 μg intravitreal implant

Study Design

Study Type:
Observational
Actual Enrollment :
875 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Study Start Date :
Mar 1, 2012
Actual Primary Completion Date :
Mar 1, 2016
Actual Study Completion Date :
Mar 1, 2016

Arms and Interventions

Arm Intervention/Treatment
OZURDEX®

OZURDEX® (dexamethasone 700 μg intravitreal implant) administered according to general clinical practice.

Drug: dexamethasone 700 μg intravitreal implant
dexamethasone 700 μg intravitreal implant administered according to general clinical practice.
Other Names:
  • OZURDEX®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of Patients Reporting Serious Adverse Events [2 years]

    2. Incidence of Patients Reporting Ophthalmic Adverse Events of Special Interest [2 years]

      The ophthalmic adverse events of special interest include: increased intraocular pressure, glaucoma, ocular hypertension, cataract formation and progression, vitreous detachment, haemorrhage, endophthalmitis (infectious/ non-infectious), retinitis secondary to reactivation of latent viral or other ophthalmic infections, retinal tear/detachment, significant vitreous leak or hypotony, systemic corticosteroid effects, and mechanical failure of device and implant misplacement.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Macular oedema following either BRVO or CRVO or non-infectious uveitis

    • Requires treatment with OZURDEX®

    Exclusion Criteria:
    • Current participation in any clinical study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Paris France
    2 Ulm Germany
    3 Barcelona Spain
    4 Bradford West Yorks United Kingdom

    Sponsors and Collaborators

    • Allergan

    Investigators

    • Study Director: Medical Director, Allergan

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Allergan
    ClinicalTrials.gov Identifier:
    NCT01539577
    Other Study ID Numbers:
    • 206207-025
    First Posted:
    Feb 27, 2012
    Last Update Posted:
    Apr 20, 2016
    Last Verified:
    Apr 1, 2016
    Additional relevant MeSH terms:
    Macular Edema
    Uveitis
    Retinal Vein Occlusion
    Uveitis, Posterior
    Dexamethasone

    Study Results

    No Results Posted as of Apr 20, 2016