Trial Condition(s):
Macular degeneration
EYLEA [AMD-QOL(Age-Related Macular Degeneration-Quality of Life)] post-marketing surveillance in Japan
Bayer Identifier:
16656
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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 | |
|---|---|
Locations Investigative Site Many Locations, Japan | 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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