N/A
Completed N=289
Retrospective Study in Patients Receiving Two or More OZURDEX® Injections for Retinal Vein Occlusion (RVO)
Source: ClinicalTrials.gov NCT01411696 ↗Enrolled (actual)
289
Serious AEs
2.4%
Results posted
Apr 2013
Primary outcomePrimary: Change From Baseline in Best Corrected Visual Acuity (BCVA) 4 to 20 Weeks Following the Last OZURDEX® (Dexamethasone Intravitreal Implant) Injection — 9.8; 1.0 Lines
Summary
This is a retrospective data collection study to evaluate the efficacy, safety, and re-injection interval of OZURDEX® in the treatment of macular edema due to RVO. Following informed consent, there were no patient study visits. All data was collected via chart review.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Best Corrected Visual Acuity (BCVA) 4 to 20 Weeks Following the Last OZURDEX® (Dexamethasone Intravitreal Implant) Injection |
9.8; 1.0 | — |
| SECONDARY Percentage of Participants With an Increase of 2 Lines or More in BCVA |
62.9 | — |
| SECONDARY Percentage of Participants With an Increase of 3 Lines or More in BCVA |
48.1 | — |
| SECONDARY Change From Baseline in Central Retinal Thickness by Optical Coherence Tomography (OCT) 4 to 20 Weeks After Each Injection |
437.8; -170.8; -177.6; -160.9; -155.5; -145.9 | — |
Eligibility Criteria
Inclusion Criteria
- Macular edema
- Received at least 2 OZURDEX® injections
Exclusion Criteria
- Received OZURDEX® injections as part of a clinical study
Data sourced from ClinicalTrials.gov (NCT01411696). 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. Informational only — not medical advice.