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

Completed

• Conditions: Macular Edema; Retinal Vein Occlusion
• Interventions: Other: No Intervention

• Registration Number: NCT01568021
• Lead Sponsor: Allergan

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2012-03-29
• Study First Submitted QC: 2012-03-30
• Study First Posted: 2012-04-02
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2015-01
• Results First Submitted: 2015-01-27
• Results First Submitted QC: 2015-01-27
• Last Update Submitted: 2015-01-27
• Results First Posted: 2015-02-10
• Last Update Posted: 2015-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Macular Edema
• Prescribed OZURDEX®

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
OZURDEX®	No Intervention	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.

Primary Outcome Measures

Name	Time	Method
Time to First Re-treatment	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

Name	Time	Method
Change From Baseline in Best Corrected Visual Acuity (BCVA) Score	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.
Change From Baseline in Central Retinal Thickness as Measured by Optical Coherence Tomography (OCT)	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.