Retrospective Study in Patients Receiving Two or More OZURDEX® Injections for Retinal Vein Occlusion (RVO)

Study Overview
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Brief Summary
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This is a retrospective data collection study to evaluate the efficacy, safety, and re-injection interval of OZURDEX® in the treatment of macular edema due to RVO. Following informed consent, there were no patient study visits. All data was collected via chart review.

Conditions
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Retinal Vein Occlusion, 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 edema Received at least 2 OZURDEX® injections Exclusion Criteria: Received OZURDEX® injections as part of a 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 2 injections of OZURDEX® (dexamethasone intravitreal implant) to treat Macular Edema. | 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 |
| --- | --- | --- |
| Change From Baseline in Best Corrected Visual Acuity (BCVA) 4 to 20 Weeks Following the Last OZURDEX® (Dexamethasone Intravitreal Implant) Injection | BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). The change in BCVA was calculated using the most improved number of lines read correctly between 4 and 20 weeks following the last injection of OZURDEX® - the number of lines read correctly at baseline. A positive change from baseline indicates improvement. | Baseline, 4 to 20 weeks after last injection (Up to 6 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants 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 (worst) to 20 (best). An increase of 2 or more lines read correctly compared to baseline is an improvement. | Baseline, Up to 6 months | 
| Percentage of Participants 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 (worst) to 20 (best). An increase of 3 or more lines read correctly compared to baseline is an improvement. | Baseline, Up to 6 months | 
| Change From Baseline in Central Retinal Thickness by Optical Coherence Tomography (OCT) 4 to 20 Weeks After Each 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 4 to 20 weeks after each injection. A negative change from baseline indicates improvement. | Baseline, 4 to 20 Weeks after Each injection (up to 6 months) |