N/A
N=573
A Safety and Efficacy Study to Assess OZURDEX® in Patients With Macular Oedema Secondary to Retinal Vein Occlusion (RVO)
Macular Edema · Retinal Vein Occlusion
Bottom Line
View on ClinicalTrials.gov: NCT01571557 ↗Enrolled (actual)
573
Serious AEs
0.2%
Results posted
Jul 2015
Primary outcome: Primary: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye — 52.431; 7.774 Approximate EDTRS Letters
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- dexamethasone 700 ug intravitreal implant (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Mar 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye |
52.431; 7.774 | — |
| SECONDARY Percentage of Patients With an Increase of ≥2 Lines From Baseline BCVA in the Study Eye |
46.60 | — |
| SECONDARY Percentage of Patients With an Increase of ≥3 Lines From Baseline BCVA in the Study Eye |
36.47 | — |
| SECONDARY Mean Change From Baseline in Central Retinal Thickness |
501.18; -61.75 | — |
Summary
This study will evaluate the relationship between time since onset of macular oedema symptoms and the achievement of vision gain in patients prescribed OZURDEX®. All care and diagnostic procedures provided are at the discretion of the participating physicians according to their clinical judgment and local standard of medical care.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of macular edema following retinal vein occlusion
- Prescribed OZURDEX®
Exclusion Criteria
- Previous treatment with OZURDEX®
Data sourced from ClinicalTrials.gov (NCT01571557). 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.