check_circleStudy Completed

Macular Degeneration

Bayer Identifier:

16656

ClinicalTrials.gov Identifier:

NCT01756261

EudraCT Number:

Not Available

EU CT Number:

Not Available
EYLEA [AMD-QOL(Age-Related Macular Degeneration-Quality of Life)] post-marketing surveillance in Japan

Trial 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.

Key Participants Requirements

Sex

Both

Age

NaN - N/A
  • - 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
  • - Patients who have already received EYLEA

Trial summary

Enrollment Goal
757
Trial Dates
December 2012 - February 2017
Phase
N/A
Could I Receive a placebo
No
Products
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Japan

Primary Outcome

  • Changes in mean NEI-VFQ-25 overall scores of patients after the first intravitreal(ITV) injection of EYLEA
    date_rangeTime Frame:
    From baseline to 6 and 12 months
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Changes in mean NEI-VFQ-25 subscale scores of patients after the first ITV injection of EYLEA
    date_rangeTime Frame:
    From baseline to 6 and 12 months
    enhanced_encryption
    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
    date_rangeTime Frame:
    From baseline to 6 and 12 months
    enhanced_encryption
    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
    date_rangeTime Frame:
    From baseline to 6 and 12 months
    enhanced_encryption
    Safety Issue:
    No

Trial design

Special Drug Use Investigation of EYLEA for Quality of Life
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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