Post Market Surveillance of OZURDEX® for Branch Retinal Vein Occlusion (BRVO) and Central Retinal Vein Occlusion (CRVO)
1 other identifier
observational
100
3 countries
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2011
Typical duration for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 29, 2012
CompletedFirst Posted
Study publicly available on registry
April 2, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedResults Posted
Study results publicly available
February 10, 2015
CompletedFebruary 10, 2015
January 1, 2015
2.1 years
March 29, 2012
January 27, 2015
January 27, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Time to First Re-treatment
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.
1 Year
Secondary Outcomes (2)
Change From Baseline in Best Corrected Visual Acuity (BCVA) Score
Baseline, Weeks 12, 24 and 48
Change From Baseline in Central Retinal Thickness as Measured by Optical Coherence Tomography (OCT)
Baseline, Weeks 12, 24 and 48
Study Arms (1)
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.
Interventions
Eligibility Criteria
Patients with BRVO and CRVO prescribed OZURDEX®
You may qualify if:
- Macular Edema
- Prescribed OZURDEX®
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (3)
Unknown Facility
Glostrup Municipality, Denmark
Unknown Facility
Oslo, Norway
Unknown Facility
Uppsala, Sweden
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Vice President Medical Affairs,
- Organization
- Allergan, Inc
Study Officials
- STUDY DIRECTOR
Medical Director
Allergan
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 29, 2012
First Posted
April 2, 2012
Study Start
October 1, 2011
Primary Completion
November 1, 2013
Study Completion
November 1, 2013
Last Updated
February 10, 2015
Results First Posted
February 10, 2015
Record last verified: 2015-01