A Safety and Efficacy Study to Assess OZURDEX® in Patients With Macular Oedema Secondary to Retinal Vein Occlusion (RVO)
Overview
- Phase
- Not Applicable
- Intervention
- dexamethasone 700 ug intravitreal implant
- Conditions
- Macular Edema
- Sponsor
- Allergan
- Enrollment
- 573
- Primary Endpoint
- Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of macular edema following retinal vein occlusion
- •Prescribed OZURDEX®
Exclusion Criteria
- •Previous treatment with OZURDEX®
Arms & Interventions
OZURDEX®
OZURDEX® (dexamethasone 700 ug intravitreal implant) administered according to standard of care.
Intervention: dexamethasone 700 ug intravitreal implant
Outcomes
Primary Outcomes
Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
Time Frame: Baseline, Week 12
BCVA is measured in the study eye following each injection of OZURDEX® using the Snellen eye chart. BCVA measurements expressed in Snellen fractions are converted to logMAR units and the approximate Early Treatment Diabetic Retinopathy Study (ETDRS) letter score is based on the formula: approximate ETDRS letters=85+50 x log10 (Snellen fraction). The converted scores are "approximate ETDRS letters" to distinguish the scores from visual acuity measurements obtained using the ETDRS chart. One line on the EDTRS equals 5 ETDRS points. The lower the number of letters read correctly on the eye chart (lower number on the decimal scale) the worse the vision (or visual acuity). The higher the number of letters read correctly (higher number on the decimal scale), the better the vision (or visual acuity). A positive number change from baseline in the number of letters read means vision has improved and a negative number change from baseline means vision has worsened.
Secondary Outcomes
- Percentage of Patients With an Increase of ≥2 Lines From Baseline BCVA in the Study Eye(Baseline, 48 Weeks)
- Percentage of Patients With an Increase of ≥3 Lines From Baseline BCVA in the Study Eye(Baseline, 48 Weeks)
- Mean Change From Baseline in Central Retinal Thickness(Baseline, Week 24)