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

NCT ID: NCT01756261

Last Updated: 2018-06-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

757 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-12-26

Study Completion Date

2017-02-27

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Macular Degeneration

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group 1

Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)

Intervention Type DRUG

Patients treated with EYLEA under practical manner for AMD.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)

Patients treated with EYLEA under practical manner for AMD.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Multiple Locations, , Japan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Japan

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

EYL-AMD-QOL

Identifier Type: OTHER

Identifier Source: secondary_id

16656

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.