Study of Ozurdex® Treatment Practice in Patients With Macular Oedema Due to Retinal Vein Occlusion
Overview
- Phase
- Not Applicable
- Intervention
- dexamethasone intravitreal implant
- Conditions
- Macular Edema
- Sponsor
- Allergan
- Enrollment
- 375
- Primary Endpoint
- Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
Epidemiological study of Ozurdex® in sites treating patients with retinal vein occlusion.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Macular oedema due to retinal vein occlusion
Exclusion Criteria
- •Not living in metropolitan France
Arms & Interventions
Ozurdex® (dexamethasone intravitreal implant)
dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
Intervention: dexamethasone intravitreal implant
Outcomes
Primary Outcomes
Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
Time Frame: Baseline, Month 6
BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened.
Secondary Outcomes
- Change From Baseline in BCVA in the Study Eye Diagnosed With Branch Retinal Vein Occlusion (BRVO)(Baseline, Month 6)
- Change From Baseline in BCVA in the Study Eye Diagnosed With Central Retinal Vein Occlusion (CRVO)(Baseline, Month 6)
- Change From Baseline in BCVA in the Study Eye in Previously Treatment Naïve Patients(Baseline, Month 6)
- Change From Baseline in BCVA in the Study Eye in Patients Previously Treated With Ozurdex®(Baseline, Month 6)
- Change From Baseline in BCVA in the Study Eye in Patients Previously Naïve to Ozurdex® Treatment(Baseline, Month 6)
- Change From Baseline in BCVA in the Study Eye Based on Macular Edema Onset <3 Months(Baseline, Month 6)
- Change From Baseline in BCVA in the Study Eye Based on Macular Edema Onset ≥3 Months(Baseline, Month 6)
- Change From Baseline in BCVA in the Study Eye in Patients Only Treated With Ozurdex®(Baseline, Month 6)
- Change From Baseline in BCVA in the Study Eye in Patients Receiving Ozurdex® and Then Other RVO Treatments(Baseline, Month 6)
- Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye(Baseline, Month 24)
- Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye(Baseline, Week 6, Month 4, Month 12, Month 18, Month 24)