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: September 13, 2016

Last verified: September 2016

History of Changes

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:

Genetics Home Reference related topics: age-related macular degeneration

MedlinePlus related topics: Macular Degeneration

Drug Information available for: Aflibercept

U.S. FDA Resources

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:	December 2017
Estimated Primary Completion Date:	December 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
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

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:

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
Study First Received:	December 20, 2012
Last Updated:	September 13, 2016
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 September 23, 2016

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