EYLEA [AMD-QOL(Age-Related Macular Degeneration-Quality of Life)] Post-marketing Surveillance in Japan
Completed
- Conditions
- Macular Degeneration
- Interventions
- Registration Number
- NCT01756261
- Lead Sponsor
- Bayer
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 757
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
Read More
Exclusion Criteria
- Patients who have already received EYLEA
Read More
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Group 1 Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) -
- Primary Outcome Measures
Name Time Method Changes in mean NEI-VFQ-25 overall scores of patients after the first intravitreal(ITV) injection of EYLEA From baseline to 6 and 12 months
- Secondary Outcome Measures
Name Time Method 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 From baseline to 6 and 12 months Changes in mean NEI-VFQ-25 subscale scores of patients after the first ITV injection of EYLEA From baseline to 6 and 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 From baseline to 6 and 12 months