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

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ClinicalTrials.gov Identifier: NCT01756261
Recruitment Status : Completed
First Posted : December 25, 2012
Last Update Posted : June 19, 2018
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Bayer

Study Description
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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
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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 : December 26, 2012
Actual Primary Completion Date : July 20, 2016
Actual Study Completion Date : February 27, 2017

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Groups and Cohorts
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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
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Primary Outcome Measures :
  1. Changes in mean NEI-VFQ-25 overall scores of patients after the first intravitreal(ITV) injection of EYLEA [ Time Frame: From baseline to 6 and 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: From baseline to 6 and 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: From baseline to 6 and 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: From baseline to 6 and 12 months ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
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
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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
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Japan
Multiple Locations, Japan
Sponsors and Collaborators
Bayer
Regeneron Pharmaceuticals
Investigators
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Study Director: Bayer Study Director Bayer
More Information
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Additional Information:

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01756261    
Other Study ID Numbers: 16656
EYL-AMD-QOL ( Other Identifier: company internal )
First Posted: December 25, 2012    Key Record Dates
Last Update Posted: June 19, 2018
Last Verified: June 2018
Keywords provided by Bayer:
EYLEA
Age-Related Macular Degeneration
QOL
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases