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

Completed

• Conditions: Retinal Vein Occlusion
• Interventions: Drug: Aflibercept (Eylea, BAY86-5321)

• Registration Number: NCT02645747
• Lead Sponsor: Bayer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-01-04
• Study First Submitted QC: 2016-01-04
• Study First Posted: 2016-01-05
• Study Start: 2016-01-21
• Primary Completion: 2017-12-23
• Study Completion: 2017-12-23
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-04
• Last Update Posted: 2018-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

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

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Exclusion Criteria

• Patients diagnosed with neovascular glaucoma secondary to CRVO will be excluded.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Aflibercept (Eylea, BAY86-5321)	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
Number of patients who discontinued their treatment with Eylea prematurely	At 12 months of treatment with Eylea	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)
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