Special Drug Use Investigation of EYLEA for Diabetic Macular Edema

Bayer

Status: Completed

Conditions: Macular Edema

Treatments: Drug: Aflibercept (Eylea, BAY86-5321)

Study type: Observational

Funder types: Industry

Identifiers

NCT02425501

17544

EY1510JP (Other Identifier)

Details and patient eligibility

About

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

Full 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).

Enrollment: 646 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Patients who have already received EYLEA treatment

Trial design

646 participants in 1 patient group

Aflibercept (Eylea,BAY86-5321)

Description:

Decision of EYLEA treatment is made by attending investigator according to the Japanese Package Insert

Treatment:

Drug: Aflibercept (Eylea, BAY86-5321)