Special Drug Use Investigation of EYLEA for Diabetic Macular Edema

Completed

• Conditions: Macular Edema
• Interventions: Drug: Aflibercept (Eylea, BAY86-5321)

• Registration Number: NCT02425501
• Lead Sponsor: Bayer

Brief Summary

The objectives of this study are to investigate the safety and effectiveness of EYLEA

Detailed Description

This is a prospective, non-interventional, multi center post-authorization safety study that includes patients with a diagnosis of myopic choroidal neovascularization. The investigator will have made the choice of treatment (EYLEA) as well as the decision to use EYLEA according the Japanese Package Insert prior to enrolling the patient in this study.

The observation period for each patient starts when therapy with EYLEA is initiated. The enrollment period is 2 years. Patients will be followed for a time period of 2 years or until it is no longer possible (e.g. lost to follow-up) within the 2 years. In total, 600 patients will be recruited.

For each patient, data are collected as defined in the electronic case report form (eCRF) at the initial visit, follow-up visits and final visit, either by routine clinical visits (as per investigators routine practice).

Study Timeline

• Study Start: 2015-01-20
• Study First Submitted: 2015-04-21
• Study First Submitted QC: 2015-04-23
• Study First Posted: 2015-04-24
• Primary Completion: 2019-04-26
• Study Completion: 2019-08-13
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-09
• Last Update Posted: 2023-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 646

Inclusion Criteria

• Patients who start EYLEA treatment for Diabetic Macular Edema (DME)

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Exclusion Criteria

• Patients who have already received EYLEA treatment

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Aflibercept (Eylea,BAY86-5321)	Aflibercept (Eylea, BAY86-5321)	Decision of EYLEA treatment is made by attending investigator according to the Japanese Package Insert

Primary Outcome Measures

Name	Time	Method
Number of participants of Adverse Events	Up to 12 months
Number of participants of Serious Adverse Events	Up to 12 months

Secondary Outcome Measures

Name	Time	Method
Mean change in visual acuity from baseline to 12 months	Baseline to 12 months
Mean change in retina thickness from baseline to 12 months	Baseline to 12 months