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Post Market Surveillance of OZURDEX® for Branch Retinal Vein Occlusion (BRVO) and Central Retinal Vein Occlusion (CRVO)

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ClinicalTrials.gov Identifier: NCT01568021
Recruitment Status : Completed
First Posted : April 2, 2012
Results First Posted : February 10, 2015
Last Update Posted : February 10, 2015
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Description
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Brief Summary:
This multicenter observational study will assess the efficacy and tolerability of OZURDEX® in clinical practice, and will assess the time at which patients are considered for retreatment.

Condition or disease Intervention/treatment
Retinal Vein Occlusion Macular Edema Other: No Intervention

Study Design
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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : October 2011
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013
Groups and Cohorts
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Group/Cohort Intervention/treatment
OZURDEX®
Single dose of dexamethasone 700 ug intravitreal implant (OZURDEX®) which may be repeated over 1 year as per standard of care in clinical practice. No intervention was administered in this study.
 Other: No Intervention
No intervention was administered in this study.


Outcome Measures
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Primary Outcome Measures :
  1. Time to First Re-treatment [ Time Frame: 1 Year ]
    Time to first re-treatment was defined as the time in days between the first administration of Ozurdex® and the following administration of Ozurdex® (re-treatment) in the study eye.


Secondary Outcome Measures :
  1. Change From Baseline in Best Corrected Visual Acuity (BCVA) Score [ Time Frame: Baseline, Weeks 12, 24 and 48 ]
    BCVA was measured in the study eye using an eye chart and was reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number improvement in the number of letters read means that the vision improved.

  2. Change From Baseline in Central Retinal Thickness as Measured by Optical Coherence Tomography (OCT) [ Time Frame: Baseline, Weeks 12, 24 and 48 ]
    Central Retinal Thickness was measured in the study eye using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina to assess retinal thickness. A negative change indicated an improvement.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with BRVO and CRVO prescribed OZURDEX®
Criteria

Inclusion Criteria:

  • Macular Edema
  • Prescribed OZURDEX®

Exclusion Criteria:

  • None
Contacts and Locations
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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): NCT01568021


Locations
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Denmark
Glostrup, Denmark
Norway
Oslo, Norway
Sweden
Uppsala, Sweden
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Medical Director Allergan
More Information
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01568021    
Other Study ID Numbers: MAF/AGN/OPH/RET/007
First Posted: April 2, 2012    Key Record Dates
Results First Posted: February 10, 2015
Last Update Posted: February 10, 2015
Last Verified: January 2015
Additional relevant MeSH terms:
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Macular Edema
Retinal Vein Occlusion
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
 Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases