Retrospective Data Analysis of Patients Treated for Macular Edema Due to Central Retinal Vein Occlusion

Study Overview
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Brief Summary
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The objective of this retrospective chart review is to evaluate drug utilization, usage patterns and indication of effectiveness Eylea in the routine clinical (real-life) management of patients who suffer from ME (Macular Edema), secondary to CRVO (Central Retinal Vein Occlusion), and who started treatment with Eylea for this indication.

Official Title
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RETRO CRVO: Retrospective Data Analysis of Patients Treated for Macular Edema Due to Central Retinal Vein Occlusion

Conditions
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Retinal Vein Occlusion

Intervention / Treatment
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* Drug: Aflibercept (Eylea, BAY86-5321)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female adult patients who suffer from visual impairment due to ME secondary to CRVO Anti-VEGF treatment-naive patients who started reimbursed Eylea treatment between the 1st of June 2014 and the 28th of February 2015 Exclusion Criteria: Patients diagnosed with neovascular glaucoma secondary to CRVO will be excluded.

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 |
| --- | --- |
| Group 1<br>The source population of this study is patients who suffer from visual impairment due to ME secondary to CRVO. In order to ensure the representativeness of the study population, the number of Belgian patients which started Eylea treatment during the brief period between the 1st of June 2014 and the 28th of February 2015 were taken into account. However, data of patients diagnosed with neovascular glaucoma secondary to CRVO will be excluded. | Drug: Aflibercept (Eylea, BAY86-5321)<br>* Eylea (intravitreal aflibercept) is an anti-Vascular Endothelial Growth Factor (VEGF) drug indicated for neovascular age-related macular degeneration (AMD), visual impairment due to diabetic macular edema (DME) and visual impairment due to macular edema (ME) secondary to central or branched retinal vein occlusion (RVO). RVO, both branch and central, is the second most common type of retinal vascular disorders after diabetic retinal disease. Central retinal vein occlusion (CRVO) is characterized by an obstruction of the central retinal vein combined with variable amounts of retinal arterial insufficiency.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment duration |  | At 12 months of treatment with Eylea | 
| Number of eyes treated (mono-and biocular) |  | At 12 months of treatment with Eylea | 
| Change in visual acuity (BCVA score) |  | At 12 months of treatment with Eylea | 
| Number of Eylea injections per treated eye |  | At 12 months of treatment with Eylea | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimation of percentage (%) of eyes which need additional treatment after 2 years at the discretion of the treating physician. |  | At 12 months of treatment with Eylea | 
| Sufficiency of reimbursed number of Eylea injections (max. 9 injections/eye in year 1) for treatment of all patients during the first year of treatment. |  | At 12 months of treatment with Eylea | 
| Number of patients who discontinued their treatment with Eylea prematurely | Investigator is asked to categorize the number of patients who ended their treatment prematurely according to the following reasons : Lost-to-follow up (measured as number of patients) Lack of efficacy (measured as number of patients) Remission (measured as number of patients) AE (measured as number of patients) Other (measured as number of patients) | At 12 months of treatment with Eylea |