Trial Condition(s):
Macular degeneration
EYLEA [AMD-QOL(Age-Related Macular Degeneration-Quality of Life)] post-marketing surveillance in Japan
Trial 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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | ||
|---|---|---|---|
Locations Investigative Site Many Locations, Japan | Status Completed | Contact Us: E-mail: [email protected] Phone: 49 30 300139003 |
Trial Design
Special Drug Use Investigation of EYLEA for Quality of Life
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Changes in mean NEI-VFQ-25 overall scores of patients after the first intravitreal(ITV) injection of EYLEATimeframe: From baseline to 6 and 12 months
Secondary Outcome
- Changes in mean NEI-VFQ-25 subscale scores of patients after the first ITV injection of EYLEATimeframe: 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, etcTimeframe: From baseline to 6 and 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, etcTimeframe: From baseline to 6 and 12 months
Additional Information
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