N/A
N=99
Post Market Surveillance of OZURDEX® for Branch Retinal Vein Occlusion (BRVO) and Central Retinal Vein Occlusion (CRVO)
Retinal Vein Occlusion · Macular Edema
Bottom Line
View on ClinicalTrials.gov: NCT01568021 ↗Enrolled (actual)
99
Serious AEs
1.0%
Results posted
Feb 2015
Primary outcome: Primary: Time to First Re-treatment — 157 days
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- No Intervention (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Nov 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to First Re-treatment |
157 | — |
| SECONDARY Change From Baseline in Best Corrected Visual Acuity (BCVA) Score |
52.8; 8.5; 6.9; 2.5 | — |
| SECONDARY Change From Baseline in Central Retinal Thickness as Measured by Optical Coherence Tomography (OCT) |
535.2; -181.3; -160.4; -147.7 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Macular Edema
- Prescribed OZURDEX®
Exclusion Criteria
- None
Data sourced from ClinicalTrials.gov (NCT01568021). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.