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

Study Overview
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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.

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

Conditions
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Macular Degeneration

Intervention / Treatment
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* Behavioral: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
* Behavioral: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Educational materials: Physicians<br> | Behavioral: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)<br>* Survey to measure physician awareness and understanding of the key messages in the educational materials: the prescriber guide and video.<br>|
| Educational materials: Patients<br> | Behavioral: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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. |  | 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. |  | Up to 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Health Care Surveys, Vascular Endothelial Growth Factor