N/A
Completed N=26
Retrospective Data Collection Study in Patients Receiving Two or More OZURDEX® Injections for Macular Oedema Secondary to Retinal Vein Occlusion
retinal vein occlusion · Macular Oedema
Source: ClinicalTrials.gov NCT01566526 ↗
Enrolled (actual)
26
Serious AEs
0.0%
Results posted
May 2013
Primary outcomePrimary: Time to OZURDEX® Re-Injection in the Study Eye — 143.65 Days
Summary
The purpose of this study is to 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) in patients who received OZURDEX® as part of the Belgium Medical Needs Program.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to OZURDEX® Re-Injection in the Study Eye |
143.65 | — |
| SECONDARY Change From Baseline in Best Corrected Visual Acuity (BCVA) 7 to 12 Weeks Following Last Injection in the Study Eye |
61.75; -5.00 | — |
| SECONDARY Percentage of Patients With an Increase of 2 Lines or More in BCVA From Baseline in the Study Eye |
50.0 | — |
| SECONDARY Percentage of Patients With an Increase of 3 Lines or More in BCVA From Baseline in the Study Eye |
42.3 | — |
| SECONDARY Change From Baseline in Central Retinal Thickness in the Study Eye by Optical Coherence Tomography (OCT) 7 to 12 Weeks Following Last Injection |
665.00; -382.17 | — |
| SECONDARY Time to Improvement of 2 Lines or More in Best Corrected Visual Acuity (BCVA) in the Study Eye |
41.0 | — |
| SECONDARY Time to Improvement of 3 Lines or More in Best Corrected Visual Acuity (BCVA) in the Study Eye |
41.0 | — |
Eligibility Criteria
Inclusion Criteria
- Macular oedema in at least one eye due to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO)
- Received at least two OZURDEX® injections in the study eye as part of the Belgium Medical Needs Program
Exclusion Criteria
- None
Data sourced from ClinicalTrials.gov (NCT01566526). 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.