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

September 14, 2017 updated by: Bayer

Evaluation of Physician and Patient Knowledge of Safety and Safe Use Information for Aflibercept in Europe: An Observational Postauthorisation Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

716

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

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Physicians eligible to participate will be ophthalmologists who have administered aflibercept in the past 6 months.

Patients eligible to participate will be those who have already received at least one aflibercept injection and are returning for a subsequent visit. Patients will be aged 18 years or older, and will be able to understand the native language of the country in which the study is conducted.

Description

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.

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
Educational materials: Physicians
Behavioral: 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.
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.
Educational materials: Patients
Behavioral: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The proportion of physicians with accurate knowledge and understanding of key safety information (identified risks and prescribing behaviors) contained in the Eylea educational materials as assessed by a study specific questionnaire.
Time Frame: Up to 2 years
Up to 2 years
The proportion of patients with accurate knowledge and understanding of key safety information (identified risks and guidelines) contained in the Eylea educational materials as assessed by a study specific interviewer administered questionnaire.
Time Frame: Up to 2 years
Up to 2 years

Collaborators and Investigators

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

Sponsor

Bayer

Collaborators

RTI Health Solutions

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 7, 2015

Primary Completion (Actual)

September 30, 2016

Study Completion (Actual)

January 31, 2017

Study Registration Dates

First Submitted

October 21, 2015

First Submitted That Met QC Criteria

November 24, 2015

First Posted (Estimate)

November 26, 2015

Study Record Updates

Last Update Posted (Actual)

September 15, 2017

Last Update Submitted That Met QC Criteria

September 14, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16526
  • EY1301 (Other Identifier: Company internal)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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