N/A
N=43
Retrospective Data Collection Study in Patients With Macular Oedema Receiving OZURDEX®
Macular Edema · Retinal Vein Occlusion
Bottom Line
View on ClinicalTrials.gov: NCT02181530 ↗Enrolled (actual)
43
Serious AEs
0.0%
Results posted
May 2015
Primary outcome: Primary: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye — 0.22; 0.18 units on a scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- No Intervention (Other)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Oct 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye |
0.22; 0.18 | — |
| SECONDARY Percentage of Patients With an Increase of 2 Lines or More in BCVA in the Study Eye |
63 | — |
| SECONDARY Percentage of Patients With an Increase of 3 Lines or More in BCVA in the Study Eye |
53 | — |
| SECONDARY Change From Baseline in Retinal Thickness as Measured by Optical Coherence Tomography (OCT) |
695.12; -355.08 | — |
| SECONDARY Time to Improvement of 2 Lines or More in BCVA in the Study Eye |
105.41 | — |
| SECONDARY Time to Improvement of 3 Lines or More in BCVA in the Study Eye |
100.48 | — |
| SECONDARY Time to OZURDEX® Re-Injection in the Study Eye |
223.00 | — |
Summary
This study will use retrospective data to evaluate the safety and efficacy of OZURDEX® (dexamethasone intravitreal implant 0.7 mg) in the treatment of macular oedema due to retinal vein occlusion (RVO) in clinical practice. No intervention will be administered as part of this study.
Eligibility Criteria
Inclusion Criteria
- Macular oedema in at least one eye due to branch retinal vein occlusion (BRVO) or central vein occlusion (CRVO)
- Received at least one injection of OZURDEX® in the study eye
Exclusion Criteria
- None
Data sourced from ClinicalTrials.gov (NCT02181530). 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.