Overview

This trial is active, not recruiting.

Condition macular degeneration
Treatment aflibercept (eylea, vegf trap-eye, bay86-5321)
Sponsor Bayer
Start date January 2013
End date December 2016
Trial size 750 participants
Trial identifier NCT01756261, 16656, EYL-AMD-QOL

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
aflibercept (eylea, vegf trap-eye, bay86-5321)
Patients treated with EYLEA under practical manner for AMD.

Primary Outcomes

Measure
Changes in mean NEI-VFQ-25 overall scores of patients after the first intravitreal(ITV) injection of EYLEA
time frame: baseline and 6 or 12 months

Secondary Outcomes

Measure
Changes in mean NEI-VFQ-25 subscale scores of patients after the first ITV injection of EYLEA
time frame: Baseline and 6 or 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
time frame: Baseline and 6 or 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, etc
time frame: Baseline and 6 or 12 months

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

Official title Special Drug Use Investigation of EYLEA for Quality of Life
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Bayer.