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

June 18, 2018 updated by: Bayer

Special Drug Use Investigation of EYLEA for Quality of Life

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

757

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Multiple Locations, Japan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with subfoveal choroidal neovascular age-related macular degeneration

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
Patients treated with EYLEA under practical manner for AMD.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in mean NEI-VFQ-25 overall scores of patients after the first intravitreal(ITV) injection of EYLEA
Time Frame: From baseline to 6 and 12 months
From baseline to 6 and 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in mean NEI-VFQ-25 subscale scores of patients after the first ITV injection of EYLEA
Time Frame: From baseline to 6 and 12 months
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
Time Frame: From baseline to 6 and 12 months
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, etc
Time Frame: From baseline to 6 and 12 months
From baseline to 6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Collaborators

Regeneron Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 26, 2012

Primary Completion (Actual)

July 20, 2016

Study Completion (Actual)

February 27, 2017

Study Registration Dates

First Submitted

December 20, 2012

First Submitted That Met QC Criteria

December 20, 2012

First Posted (Estimate)

December 25, 2012

Study Record Updates

Last Update Posted (Actual)

June 19, 2018

Last Update Submitted That Met QC Criteria

June 18, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16656
  • EYL-AMD-QOL (Other Identifier: company internal)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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3
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