Retrospective Data Collection Study in Patients Receiving Two or More OZURDEX® Injections for Macular Oedema Secondary to Retinal Vein Occlusion

Study Overview
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Brief Summary
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The purpose of this study is to use retrospective data to evaluate the efficacy, safety and re-injection interval of OZURDEX® in the treatment of macular oedema due to retinal vein occlusion (RVO) in patients who received OZURDEX® as part of the Belgium Medical Needs Program.

Conditions
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Retinal Vein Occlusion, Macular Oedema

Intervention / Treatment
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* Drug: dexamethasone intravitreal implant 0.7 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Macular oedema in at least one eye due to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO) Received at least two OZURDEX® injections in the study eye as part of the Belgium Medical Needs Program Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients Previously Treated with OZURDEX®<br>OZURDEX® administered at least twice in accordance with routine clinical practice as part of the Belgium Medical Needs Program. | Drug: dexamethasone intravitreal implant 0.7 mg<br>* OZURDEX® administered at least twice in accordance with routine clinical practice as part of the Belgium Medical Needs Program.<br>* Other names: OZURDEX®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to OZURDEX® Re-Injection in the Study Eye | The time interval is measured from the first OZURDEX® injection to the second OZURDEX® injection in the study eye. | Up to 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Best Corrected Visual Acuity (BCVA) 7 to 12 Weeks Following Last Injection in the Study Eye | BCVA is measured in the study eye following each injection of OZURDEX® using a special 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 improvement in the number of letters read means that the vision has improved. Data are reported for the 7-12 week period following the last injection. | Baseline, 7 to 12 weeks following the last injection | 
| Percentage of Patients With an Increase of 2 Lines or More in BCVA From Baseline in the Study Eye | BCVA following the first injection of OZURDEX® is measured in the study eye using a special eye chart and is reported as the number of lines (5 letters per line) read correctly. An increase of 2 lines or more indicates an improvement. | Baseline, Up to 12 Months | 
| Percentage of Patients With an Increase of 3 Lines or More in BCVA From Baseline in the Study Eye | BCVA following the first injection of OZURDEX® is measured in the study eye using a special eye chart and is reported as the number of lines (5 letters per line) read correctly. An increase of 3 lines or more indicates an improvement. | Baseline, Up to 12 Months | 
| Change From Baseline in Central Retinal Thickness in the Study Eye by Optical Coherence Tomography (OCT) 7 to 12 Weeks Following Last Injection | OCT is measured in the study eye following each injection of OZURDEX®. OCT is a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina to assess retinal thickness. A negative change indicates an improvement. Data are reported for the 7-12 week period following the last injection. | Baseline, 7 to 12 weeks following the last injection | 
| Time to Improvement of 2 Lines or More in Best Corrected Visual Acuity (BCVA) in the Study Eye | BCVA following the first injection of OZURDEX® is measured in the study eye using a special eye chart and is reported as the number of lines (5 letters per line) read correctly. An increase of 2 lines or more indicates an improvement. | Baseline, Up to 12 Months | 
| Time to Improvement of 3 Lines or More in Best Corrected Visual Acuity (BCVA) in the Study Eye | BCVA following the first injection of OZURDEX® is measured in the study eye using a special eye chart and is reported as the number of lines (5 letters per line) read correctly. An increase of 3 lines or more indicates an improvement. | Baseline, Up to 12 Months |