Overview

This trial is active, not recruiting.

Condition macular degeneration
Treatments aflibercept (eylea, vegf trap-eye, bay86-5321)
Sponsor Bayer
Collaborator RTI Health Solutions
Start date December 2015
End date September 2016
Trial size 716 participants
Trial identifier NCT02615496, 16526, EY1301

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Time perspective cross-sectional
Arm
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.
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.

Primary Outcomes

Measure
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
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

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Evaluation of Physician and Patient Knowledge of Safety and Safe Use Information for Aflibercept in Europe: An Observational Postauthorisation Study
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Bayer.