N/A
N=375
Study of Ozurdex® Treatment Practice in Patients With Macular Oedema Due to Retinal Vein Occlusion
Macular Edema · Retinal Vein Occlusion
Bottom Line
View on ClinicalTrials.gov: NCT01618266 ↗Enrolled (actual)
375
Serious AEs
26.1%
Results posted
Feb 2016
Primary outcome: Primary: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye — 47.56; 5.09 Letters
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- dexamethasone intravitreal implant (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Apr 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye |
47.6; 11.41; 3.08; 2.85; 3.02; 4.64 | — |
| SECONDARY Change From Baseline in BCVA in the Study Eye Diagnosed With Branch Retinal Vein Occlusion (BRVO) |
52.80; 5.50 | — |
| SECONDARY Change From Baseline in BCVA in the Study Eye Diagnosed With Central Retinal Vein Occlusion (CRVO) |
41.45; 4.63 | — |
| SECONDARY Change From Baseline in BCVA in the Study Eye in Previously Treatment Naïve Patients |
43.94; 7.45 | — |
| SECONDARY Change From Baseline in BCVA in the Study Eye in Patients Previously Treated With Ozurdex® |
52.46; 1.95 | — |
| SECONDARY Change From Baseline in BCVA in the Study Eye in Patients Previously Naïve to Ozurdex® Treatment |
45.29; 8.39 | — |
| SECONDARY Change From Baseline in BCVA in the Study Eye Based on Macular Edema Onset <3 Months |
43.27; 8.53 | — |
| SECONDARY Change From Baseline in BCVA in the Study Eye Based on Macular Edema Onset ≥3 Months |
51.44; 1.96 | — |
| SECONDARY Change From Baseline in BCVA in the Study Eye in Patients Only Treated With Ozurdex® |
49.28; 5.48 | — |
| SECONDARY Change From Baseline in BCVA in the Study Eye in Patients Receiving Ozurdex® and Then Other RVO Treatments |
43.97; 4.25 | — |
| SECONDARY Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye |
47.6; 11.41; 3.08; 2.85; 3.02; 4.64 | — |
| SECONDARY Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye |
38.7 | — |
Summary
Epidemiological study of Ozurdex® in sites treating patients with retinal vein occlusion.
Eligibility Criteria
Inclusion Criteria
- Macular oedema due to retinal vein occlusion
Exclusion Criteria
- Not living in metropolitan France
Data sourced from ClinicalTrials.gov (NCT01618266). 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.