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
2 other identifiers
observational
757
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2012
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 20, 2012
CompletedFirst Posted
Study publicly available on registry
December 25, 2012
CompletedStudy Start
First participant enrolled
December 26, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 20, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 27, 2017
CompletedJune 19, 2018
June 1, 2018
3.6 years
December 20, 2012
June 18, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in mean NEI-VFQ-25 overall scores of patients after the first intravitreal(ITV) injection of EYLEA
From baseline to 6 and 12 months
Secondary Outcomes (3)
Changes in mean NEI-VFQ-25 subscale scores of patients after the first ITV injection of EYLEA
From 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, etc
From 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, etc
From baseline to 6 and 12 months
Study Arms (1)
Group 1
Interventions
Patients treated with EYLEA under practical manner for AMD.
Eligibility Criteria
Patients with subfoveal choroidal neovascular age-related macular degeneration
You may qualify if:
- 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
You may not qualify if:
- Patients who have already received EYLEA
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
- Regeneron Pharmaceuticalscollaborator
Study Sites (1)
Unknown Facility
Multiple Locations, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 20, 2012
First Posted
December 25, 2012
Study Start
December 26, 2012
Primary Completion
July 20, 2016
Study Completion
February 27, 2017
Last Updated
June 19, 2018
Record last verified: 2018-06