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
: February 5, 2018
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Condition or disease | Intervention/treatment |
---|---|
Macular Degeneration | Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) |
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 |

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

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Ages Eligible for Study: | Child, Adult, Senior |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

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
Japan | |
Multiple Locations, Japan |
Study Director: | Bayer Study Director | Bayer |
Additional Information:
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 |