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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02615496

Enrollment

716

Registered

2015-11-26

Start date

2015-12-07

Completion date

2017-01-31

Last updated

2017-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Macular Degeneration

Keywords

Health Care Surveys, Vascular Endothelial Growth Factor

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.

Interventions

BEHAVIORALAflibercept (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.

Study design

Observational model

OTHER

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	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

Countries

France, Germany, Italy, Spain, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026