Retrospective Data Collection Study in Patients With Macular Oedema Receiving OZURDEX®
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Macular Edema
- Sponsor
- Allergan
- Enrollment
- 43
- 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
This study will use retrospective data to evaluate the safety and efficacy of OZURDEX® (dexamethasone intravitreal implant 0.7 mg) in the treatment of macular oedema due to retinal vein occlusion (RVO) in clinical practice. No intervention will be administered as part of this study.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Macular oedema in at least one eye due to branch retinal vein occlusion (BRVO) or central vein occlusion (CRVO)
- •Received at least one injection of OZURDEX® in the study eye
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
Time Frame: Baseline, 7 to 12 weeks following the first OZURDEX® injection
BCVA is measured in the study eye following each injection of OZURDEX® using a special eye chart. The number of letters read correctly Snellen fraction are converted to a decimal scale. There are 11 lines on a standard Snellen chart ranging from 0.1 (20/200) at worst to 2.0 (20/10) at best. 20/20 on the decimal scale is equal to 1.0. 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 improvement in the number of letters read means that the vision has improved.
Secondary Outcomes
- Percentage of Patients With an Increase of 2 Lines or More in BCVA in the Study Eye(Baseline, Up to 17 Months)
- Percentage of Patients With an Increase of 3 Lines or More in BCVA in the Study Eye(Baseline, Up to 17 Months)
- Change From Baseline in Retinal Thickness as Measured by Optical Coherence Tomography (OCT)(Baseline, 7 to 12 weeks following the first OZURDEX® injection)
- Time to Improvement of 2 Lines or More in BCVA in the Study Eye(Baseline, Up to 17 Months)
- Time to Improvement of 3 Lines or More in BCVA in the Study Eye(Baseline, Up to 17 Months)
- Time to OZURDEX® Re-Injection in the Study Eye(Up to 17 Months)