Evaluation of Physician and Patient Knowledge of Safety and Safe Use Information for Aflibercept

NCT ID: NCT02615496

Last Updated: 2017-09-15

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

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Recruitment Status

COMPLETED

Total Enrollment

716 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-12-07

Study Completion Date

2017-01-31

Brief Summary

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The study will be an observational, cross-sectional study of knowledge, understanding, and self-reported behavior among a sample of physicians and patients with recent aflibercept experience in a total of up to five European countries.

Detailed Description

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Conditions

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Macular Degeneration

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Educational materials: Physicians

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

Intervention Type BEHAVIORAL

Survey to measure physician awareness and understanding of the key messages in the educational materials: the prescriber guide and video.

Educational materials: Patients

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

Intervention Type BEHAVIORAL

Survey to measure patient awareness and understanding of the key messages in the educational materials: the patient booklet "Your guide to EYLEA," patient information leaflet, and audio CD.

Interventions

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

Survey to measure physician awareness and understanding of the key messages in the educational materials: the prescriber guide and video.

Intervention Type BEHAVIORAL

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

Survey to measure patient awareness and understanding of the key messages in the educational materials: the patient booklet "Your guide to EYLEA," patient information leaflet, and audio CD.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

Physicians eligibility:

* Licensed and practicing ophthalmologist
* Prescribed and administered aflibercept to at least one patient in the past 6 months

Patients eligibility:

* Patient has been administered aflibercept at least once within the last 6 months for any indication and is returning for a subsequent visit.
* Patient is aged 18 years or older.
* Patient is able to understand and sign the consent form and patient questionnaire.
* Patient can understand the native language of the country in which the study is being conducted.
* Patient has not participated in a clinical trial for the treatment of an aflibercept indication (e.g., wAMD, CRVO, or DME) in the past 12 months.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RTI Health Solutions

OTHER

Sponsor Role collaborator

Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Many Locations, , France

Site Status

Many Locations, , Germany

Site Status

Many Locations, , Italy

Site Status

Many Locations, , Spain

Site Status

Many Locations, , United Kingdom

Site Status

Countries

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France Germany Italy Spain United Kingdom

Other Identifiers

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EY1301

Identifier Type: OTHER

Identifier Source: secondary_id

16526

Identifier Type: -

Identifier Source: org_study_id