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

Bayer

Status: Completed

Conditions: Macular Degeneration

Treatments: Behavioral: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02615496

EY1301 (Other Identifier)

16526

Details and patient eligibility

About

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.

Enrollment: 716 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

716 participants in 2 patient groups

Educational materials: Physicians

Treatment:

Behavioral: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)

Behavioral: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)

Educational materials: Patients

Treatment:

Behavioral: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)

Behavioral: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)