Skip to content

EYLEA [AMD-QOL(Age-Related Macular Degeneration-Quality of Life)] Post-marketing Surveillance in Japan

Special Drug Use Investigation of EYLEA for Quality of Life

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01756261
Enrollment
757
Registered
2012-12-25
Start date
2012-12-26
Completion date
2017-02-27
Last updated
2018-06-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Macular Degeneration

Keywords

EYLEA, Age-Related Macular Degeneration, QOL

Brief summary

The objective of this survey is to evaluate effectiveness of EYLEA on Quality of Life (QOL). The QOL is evaluated by using Japanese version (v.1.4 - interviewer administered format) of National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) and compared at baseline and at the 6 and 12 months after start of EYLEA treatment.

Interventions

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

Patients treated with EYLEA under practical manner for AMD.

Sponsors

Regeneron Pharmaceuticals
CollaboratorINDUSTRY
Bayer
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Patients who have been determined to start EYLEA treatment * Patients who are registered to Special drug use investigation of EYLEA for AMD(Trial Number 15858) * Patients who have agreed with the patient informed consent

Exclusion criteria

* Patients who have already received EYLEA

Design outcomes

Primary

MeasureTime frame
Changes in mean NEI-VFQ-25 overall scores of patients after the first intravitreal(ITV) injection of EYLEAFrom baseline to 6 and 12 months

Secondary

MeasureTime frame
Changes in mean NEI-VFQ-25 subscale scores of patients after the first ITV injection of EYLEAFrom baseline to 6 and 12 months
Changes in mean NEI-VFQ-25 overall scores after the first ITV injection of EYLEA in subpopulations of patient background characteristics and status of EYLEA treatments, ie. Frequency, visual acuity, etcFrom baseline to 6 and 12 months
Changes in mean NEI-VFQ-25 subscale scores after the first ITV injection of EYLEA in subpopulations of patient background characteristics and status of EYLEA treatments, ie. Frequency, visual acuity, etcFrom baseline to 6 and 12 months

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026