Caregiver Burden of Wet Age-related Macular Degeneration (wAMD) in Japan
NCT ID: NCT02541084
Last Updated: 2017-08-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
72 participants
OBSERVATIONAL
2015-08-18
2016-07-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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PRN group
wAMD-patients treated with anti-VEGF therapy ´pro re nata´ (PRN)
Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
Anti-VEGF therapy following the Summary of Product Characteristics
TAE group
wAMD-patients treated with anti-VEGF therapy ´treat-and-extend´ (TAE)
Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
Anti-VEGF therapy following the Summary of Product Characteristics
PRN-to-TAE switcher group
wAMD patients treated with anti-VEGF therapy and switching from PRN to TAE regimens
Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
Anti-VEGF therapy following the Summary of Product Characteristics
Interventions
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Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
Anti-VEGF therapy following the Summary of Product Characteristics
Eligibility Criteria
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Inclusion Criteria
* Female and male out-patients diagnosed with wAMD.
* Patients who are accompanied by his/her caregiver(s).
* Patients who have been receiving anti-VEGF therapy with proactive regimen for 12 months or more at the participating site.
* Providing informed consent for the participation in this study.
* \[Caregivers\]
* Providing informed consent for the participation in this study.
* Capable of understanding and completing the questionnaires without any help from others
Exclusion Criteria
* Presence of a disease or a condition more disabling than wAMD in term of caregiving.
* Presence of intractable neurologic disease, physical handicap, mental handicap, or any condition that rendered them unable to walk independently.
* Intraocular surgery for other eye diseases after the start of wAMD therapy.
* \[Caregivers\]
* Professional carers
ALL
No
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Many Locations, , Japan
Countries
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Other Identifiers
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17945
Identifier Type: -
Identifier Source: org_study_id
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