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EYLEA [AMD-QOL(Age-Related Macular Degeneration-Quality of Life)] Post-marketing Surveillance in Japan
This study is ongoing, but not recruiting participants.
Sponsor:
Bayer
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01756261
First received: December 20, 2012
Last updated: May 12, 2017
Last verified: May 2017
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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 ]
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 ]
- 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 ]
| Enrollment: | 757 |
| Actual Study Start Date: | January 11, 2013 |
| Estimated Study Completion Date: | December 30, 2017 |
| Primary Completion Date: | July 20, 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 |
| 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
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
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:
| Responsible Party: | Bayer |
| ClinicalTrials.gov Identifier: | NCT01756261 History of Changes |
| Other Study ID Numbers: |
16656 EYL-AMD-QOL ( Other Identifier: company internal ) |
| Study First Received: | December 20, 2012 |
| Last Updated: | May 12, 2017 |
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 July 19, 2017