EYLEA [AMD-QOL(Age-Related Macular Degeneration-Quality of Life)] Post-marketing Surveillance in Japan
- Sponsor
- Bayer
- Study ID
- NCT01756261
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- N/A - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) — DRUGPatients treated with EYLEA under practical manner for AMD.
Study Details
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 Dates
- Start date
- Dec 26, 2012
- Status verified
- Jun 2018
- Primary completion
- Jul 20, 2016
- Completion
- Feb 27, 2017
Study Design
- Enrollment
- 757 participants (actual)
Arms
- Arm: Group 1
Primary Outcome Measure
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 ]
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