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

Completed

• Conditions: Macular Degeneration
• Interventions: Behavioral: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)

• Registration Number: NCT02615496
• Lead Sponsor: Bayer

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-10-21
• Study First Submitted QC: 2015-11-24
• Study First Posted: 2015-11-26
• Study Start: 2015-12-07
• Primary Completion: 2016-09-30
• Study Completion: 2017-01-31
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-14
• Last Update Posted: 2017-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 716

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.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Educational materials: Patients	Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)	-
Educational materials: Physicians	Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)	-

Primary Outcome Measures

Name	Time	Method
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