EYLEA Age-Related Macular Degeneration (AMD) Post-marketing Surveillance in Japan

Sponsor
Bayer
Study ID
NCT01756248
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Dec 26, 2012
Status verified
Jun 2023
Primary completion
Dec 31, 2018
Completion
May 20, 2019

Study Design

Enrollment
3,872 participants (actual)

Arms

  • Arm: Group 1

Primary Outcome Measure

Number of participants with adverse drug reactions(ADRs) and infections from the first intravitreal(ITV) injection of EYLEA [ Time Frame: Up to 3 years ]

Related Studies