ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01756261
Recruitment Status : Completed
First Posted : December 25, 2012
Last Update Posted : February 5, 2018
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Description
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

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

Study Design
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Observational
Actual Enrollment : 757 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Special Drug Use Investigation of EYLEA for Quality of Life
Actual Study Start Date : January 11, 2013
Actual Primary Completion Date : July 20, 2016
Actual Study Completion Date : February 27, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Aflibercept
U.S. FDA Resources

Groups and Cohorts
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
Group 1 Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
Patients treated with EYLEA under practical manner for AMD.


Outcome Measures
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 :
  1. 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 ]
  2. 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 ]
  3. 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 ]

Eligibility Criteria
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01756261


Locations
Japan
Multiple Locations, Japan
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
More Information
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01756261     History of Changes
Other Study ID Numbers: 16656
EYL-AMD-QOL ( Other Identifier: company internal )
First Posted: December 25, 2012    Key Record Dates
Last Update Posted: February 5, 2018
Last Verified: February 2018

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

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