N/A
Completed N=87
A Retrospective Data Collection Study in Patients Receiving Dexamethasone Intravitreal Implant (Ozurdex®) for Macular Oedema Due to Retinal Vein Occlusion (RVO)
Source: ClinicalTrials.gov NCT01445626 ↗Enrolled (actual)
87
Serious AEs
6.9%
Results posted
Feb 2013
Primary outcomePrimary: Time to OZURDEX® Re-injection — 140.80 Days
Summary
This study will use retrospective data to evaluate the efficacy, safety, and re-injection interval of OZURDEX® in the treatment of macular oedema due to Retinal Vein Occlusion (RVO).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to OZURDEX® Re-injection |
140.80 | — |
| SECONDARY Change From Baseline in Best Corrected Visual Acuity (BCVA) 7 to 12 Weeks Following the Last Injection |
50.97; 10.89 | — |
| SECONDARY Percentage of Patients With an Increase of 2 Lines or More in BCVA |
56.3 | — |
| SECONDARY Percentage of Patients With an Increase of 3 Lines or More in BCVA |
50.6 | — |
| SECONDARY Change From Baseline in Central Retinal Thickness by Optical Coherence Tomography (OCT) 7 to 12 Weeks Following the Last Injection |
576.85; -259.21 | — |
| SECONDARY Time to Improvement of 2 Lines or More in BCVA |
55.0 | — |
| SECONDARY Time to Improvement of 3 Lines or More in BCVA |
57.0 | — |
Eligibility Criteria
Inclusion Criteria
- Macular oedema in the study eye due to BRVO or CRVO
- Received at least 2 OZURDEX® injections in the study eye
Exclusion Criteria
- Received OZURDEX® injections as part of or during any clinical study
Data sourced from ClinicalTrials.gov (NCT01445626). 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.