Evaluation of Physician and Patient Knowledge of Safety and Safe Use Information for Aflibercept in Europe: An Observational Postauthorisation Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Bayer
- Enrollment
- 716
- Primary Endpoint
- 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.
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported