A Retrospective Data Collection Study in Patients Receiving Dexamethasone Intravitreal Implant (Ozurdex®) for Macular Oedema Due to Retinal Vein Occlusion (RVO)

Study Overview
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Brief Summary
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This study will 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).

Conditions
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Macular Edema

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 the study eye due to BRVO or CRVO Received at least 2 OZURDEX® injections in the study eye Exclusion Criteria: Received OZURDEX® injections as part of or during any clinical study

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 |
| --- | --- |
| All participants<br>Patients who received at least two OZURDEX® (dexamethasone intravitreal implant) injections. | Drug: dexamethasone intravitreal implant 0.7 mg<br>* Dexamethasone intravitreal implant 0.7 mg was dosed previously according to general clinical practice.<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 | Time to OZURDEX® re-injection is the time in days between the first and second OZURDEX® injections. | 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 the Last Injection | BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of letters ranging from 0 (worse) to 100 (best). The change in BCVA was calculated using the most improved number of letters read correctly between 7 and 12 weeks following the last injection of OZURDEX® - the number of letters read correctly at baseline. A positive change from baseline indicates improvement. | Baseline, 7 to 12 weeks following the last injection | 
| Percentage of Patients With an Increase of 2 Lines or More in BCVA | BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worse) to 20 (best). An increase of 2 or more lines read correctly compared to baseline is an improvement. | Baseline, Up to 12 months | 
| Percentage of Patients With an Increase of 3 Lines or More in BCVA | BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worse) to 20 (best). An increase of 3 or more lines read correctly compared to baseline is an improvement. | Baseline, Up to 12 months | 
| Change From Baseline in Central Retinal Thickness by Optical Coherence Tomography (OCT) 7 to 12 Weeks Following the Last Injection | Optical Coherence Tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina, was performed in the study eye after pupil dilation at baseline and 7 to 12 weeks after the last injection. A negative change from baseline indicates improvement. | Baseline, 7 to 12 weeks following the last injection | 
| Time to Improvement of 2 Lines or More in BCVA | Time to improvement of 2 lines or more in BCVA is defined as the number of days after the first injection of OZURDEX® to achieve an improvement of 2 or more lines read correctly compared to baseline. BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worse) to 20 (best). | Baseline, Up to 12 months | 
| Time to Improvement of 3 Lines or More in BCVA | Time to improvement of 3 lines or more in BCVA is defined as the number of days after the first injection of OZURDEX® to achieve an improvement of 3 or more lines read correctly compared to baseline. BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worse) to 20 (best). | Baseline, Up to 12 months |