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Completed

NCT Number: NCT01756248

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

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.

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Key information

Conditions

Macular Degeneration Eye Diseases Retinal Degeneration Retinal Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Multiple Locations, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who received EYLEA for AMD

Exclusion criteria

  • Patients who have already received EYLEA

Treatment and study plan

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

Drug

Patients treated with EYLEA under practical manner for AMD.

Primary outcomes

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

    Time frame: Up to 3 years

  2. 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

    Time frame: Up to 3 years

Secondary outcomes

  1. 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

    Time frame: Up to 3 years

  2. Mean changes in visual acuity

    Time frame: Baseline and 6, 24 or 36 months

  3. 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)

    Time frame: Up to 3 years

  4. Mean changes in visual acuity in subpopulations of patients background characteristics and status of EYLEA treatments

    Time frame: Baseline and 6, 24 or 36 months

  5. Number and intervals of ITV injection of EYLEA

    Time frame: Up to 3 years

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • Regeneron Pharmaceuticals

Registry information

Official study title

Special Drug Use Investigation of EYLEA for AMD

Important dates

Study start
2012
Primary completion
2018
Study completion
2019
First posted
Dec 25, 2012
Registry last updated
Jun 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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