Post Market Surveillance of OZURDEX® for Branch Retinal Vein Occlusion (BRVO) and Central Retinal Vein Occlusion (CRVO)
|ClinicalTrials.gov Identifier: NCT01568021|
Recruitment Status : Completed
First Posted : April 2, 2012
Results First Posted : February 10, 2015
Last Update Posted : February 10, 2015
|Condition or disease||Intervention/treatment|
|Retinal Vein Occlusion Macular Edema||Other: No Intervention|
|Study Type :||Observational|
|Actual Enrollment :||100 participants|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||November 2013|
|Actual Study Completion Date :||November 2013|
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.
- 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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01568021
|Study Director:||Medical Director||Allergan|