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

Completed

• Conditions: Macular Degeneration
• Interventions: Drug: Aflibercept(Eylea, VEGF Trap-Eye, BAY86-5321)

• Registration Number: NCT01756248
• Lead Sponsor: Bayer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-12-20
• Study First Submitted QC: 2012-12-20
• Study First Posted: 2012-12-25
• Study Start: 2012-12-26
• Primary Completion: 2018-12-31
• Study Completion: 2019-05-20
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-06
• Last Update Posted: 2023-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3872

Inclusion Criteria

• Patients who received EYLEA for AMD

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Exclusion Criteria

• Patients who have already received EYLEA

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Aflibercept(Eylea, VEGF Trap-Eye, BAY86-5321)	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Mean changes in visual acuity	Baseline and 6, 24 or 36 months
Number of participants with ADRs, SAEs and ocular AEs ( especially AEs due to ITV injection procedure) in subpopulations of patients background characteristics and status of EYLEA treatments from the first ITV injection of EYLEA	Up to 3 years
Proportion of patients who maintained visual acuity(corresponding to <15 letters of Early Treatment Diabetic Retinopathy Study(ETDRS) from baseline) and improved visual acuity(corresponding to >0 letter of ETDRS from baseline)	Up to 3 years
Mean changes in visual acuity in subpopulations of patients background characteristics and status of EYLEA treatments	Baseline and 6, 24 or 36 months
Number and intervals of ITV injection of EYLEA	Up to 3 years