NCT02425501

Special Drug Use Investigation of EYLEA for Diabetic Macular Edema

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 646 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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).

Conditions

• Macular Edema

Interventions

Type	Name	Description
DRUG	Aflibercept (Eylea, BAY86-5321)	Administration by intravitreal injection

Timeline

• Start date: 2015-01-20
• Primary completion: 2019-04-26
• Completion: 2019-08-13
• First posted: 2015-04-24
• Last updated: 2023-01-11

Locations

1 site across 1 country: Japan