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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01756261
First received: December 20, 2012
Last updated: May 12, 2017
Last verified: May 2017
  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 ]

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 ]
  • 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 ]
  • 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 ]

Enrollment: 757
Actual Study Start Date: January 11, 2013
Estimated Study Completion Date: December 30, 2017
Primary Completion Date: July 20, 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

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01756261     History of Changes
Other Study ID Numbers: 16656
EYL-AMD-QOL ( Other Identifier: company internal )
Study First Received: December 20, 2012
Last Updated: May 12, 2017

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 July 19, 2017