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

This study is currently recruiting participants.
Verified April 2014 by Bayer
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01756261
First received: December 20, 2012
Last updated: April 18, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Macular Degeneration
Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Special Drug Use Investigation of EYLEA for Quality of Life

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Changes in mean NEI-VFQ-25 overall scores of patients after the first intravitreal(ITV) injection of EYLEA [ Time Frame: baseline and 6 or 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in mean NEI-VFQ-25 subscale scores of patients after the first ITV injection of EYLEA [ Time Frame: Baseline and 6 or 12 months ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: Baseline and 6 or 12 months ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: Baseline and 6 or 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 750
Study Start Date: January 2013
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
Patients treated with EYLEA under practical manner for AMD.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with subfoveal choroidal neovascular age-related macular degeneration

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01756261

Contacts
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com

Locations
Japan
Recruiting
Many Locations, Japan
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01756261     History of Changes
Other Study ID Numbers: 16656, EYL-AMD-QOL
Study First Received: December 20, 2012
Last Updated: April 18, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Bayer:
EYLEA
Age-Related Macular Degeneration
QOL

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on April 21, 2014