EYLEA [AMD-QOL(Age-Related Macular Degeneration-Quality of Life)] Post-marketing Surveillance in Japan

Macular Degeneration Clinical Trial

Official title:

Special Drug Use Investigation of EYLEA for Quality of Life

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01756261
• Other study ID #: 16656
• Secondary ID: EYL-AMD-QOL
• Status: Completed
• Start date: December 26, 2012
• Est. completion date: February 27, 2017

Study information

• Verified date: June 2018
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 757
• Est. completion date: February 27, 2017
• Est. primary completion date: July 20, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Macular Degeneration

Intervention

Drug:
• Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
Patients treated with EYLEA under practical manner for AMD.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Regeneron Pharmaceuticals

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Changes in mean NEI-VFQ-25 subscale scores of patients after the first ITV injection of EYLEA		From baseline to 6 and 12 months
Secondary	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
Secondary	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

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