Clinical trial

Special Drug Use Investigation of EYLEA for AMD

Name

15895

Description

This study is a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received EYLEA for Age-Related Macular Degeneration (AMD). The objective of this study is to assess safety and effectiveness of EYLEA using in real clinical practice. A total of 4,000 patients are to be enrolled and assessed in 3 years standard observational period. An annual follow-up survey will be conducted for 5 years at the longest after standard observational period.

Trial arms

Trial start

2012-12-26

Estimated PCD

2018-12-31

Trial end

2019-05-20

Status

Completed

Treatment

Aflibercept(Eylea, VEGF Trap-Eye, BAY86-5321)

Patients treated with EYLEA under practical manner for AMD.

Arms:

Group 1

Size

3872

Primary endpoint

Number of participants with adverse drug reactions(ADRs) and infections from the first intravitreal(ITV) injection of EYLEA

Up to 3 years

Number of participants with serious adverse events (SAEs) and ocular adverse events(AEs) (especially AEs due to ITV injection procedure) from the first ITV injection of EYLEA

Up to 3 years

Eligibility criteria

Inclusion Criteria: * Patients who received EYLEA for AMD Exclusion Criteria: * Patients who have already received EYLEA

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 3872, 'type': 'ACTUAL'}}

Updated at

2023-06-07

1 organization

1 product

1 indication

Organization

Bayer

Product

Aflibercept

Indication

Age-Related Macular Degeneration