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

Macular Degeneration Clinical Trial

Official title:

Special Drug Use Investigation of EYLEA for AMD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01756248
• Other study ID #: 15895
• Secondary ID: EYL-AMD
• Status: Completed
• Start date: December 26, 2012
• Est. completion date: May 20, 2019

Study information

• Verified date: June 2023
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3872
• Est. completion date: May 20, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients who received EYLEA for AMD

Exclusion Criteria:

• Patients who have already received EYLEA

Related Conditions & MeSH terms

• Macular Degeneration

Intervention

Drug:
• Aflibercept(Eylea, VEGF Trap-Eye, BAY86-5321)
Patients treated with EYLEA under practical manner for AMD.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Regeneron Pharmaceuticals

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse drug reactions(ADRs) and infections from the first intravitreal(ITV) injection of EYLEA		Up to 3 years
Primary	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
Secondary	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
Secondary	Mean changes in visual acuity		Baseline and 6, 24 or 36 months
Secondary	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
Secondary	Mean changes in visual acuity in subpopulations of patients background characteristics and status of EYLEA treatments		Baseline and 6, 24 or 36 months
Secondary	Number and intervals of ITV injection of EYLEA		Up to 3 years

External Links

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