Evaluation of Physician Knowledge of Safety and Safe Use Information for Aflibercept in Canada

The primary objective of this study is to measure physician knowledge and understanding of the key safety information contained in the Eylea vial preparation instruction card, the intravitreal injection procedure video, and the product monograph.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age-related Macular Degeneration (AMD) Cardiovascular Diseases Central Retinal Vein Occlusion (CRVO) Diabetic Macular Edema (DME) Embolism and Thrombosis Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases Retinal Vein Occlusion Thrombosis Vascular Diseases Venous Thrombosis

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations, Canada

About this study

The source of information for the study will be self-reported data collected from physicians using standard questionnaires with closed-ended response choices. Questionnaires for physicians will be developed and tested using best practices for instrument development. The questions will be tailored to the study aims and the information provided in the the vial preparation instruction card, the intravitreal injection procedure video, and the Eylea product monograph.

Other questions will obtain information needed to assess potential differences across subgroups and identify any biases (e.g., demographics, experience with Eylea).

The questionnaire will be tested through cognitive interviews with physicians. Questionnaires will be tested in local languages, to assure that the introductory material, consent forms, and questionnaire items (question stems and response choices) are culturally appropriate and easily and correctly understood by individuals similar to those who will participate

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

This study will be conducted with retinal specialists and ophthalmologists in Canada who have prescribed and/or administered aflibercept to at least 1 patient in the past 6 months.

Exclusion criteria

None applied

Treatment and study plan

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

Drug

The physician questionnaire will contain primarily closed-ended questions (e.g., multiple choice, true/false), with few free-text response fields, eliciting responses measuring physician knowledge and understanding of the key information in the Eylea vial preparation instruction card, the intravitreal injection procedure video, and the product monograph.

Primary outcomes

Knowledge and understanding of key information contained in the aflibercept educational materials: the Eylea vial preparation instruction card, the intravitreal injection procedure video, and the product monograph

Time frame: Up to 8 weeks after the start of data collection

The source of information for the study will be self-reported data collected from physicians using standard questionnaires with closed-ended response choices.

Secondary outcomes

Investigation whether physicians have received the educational materials

Time frame: up to 6 month

Descriptive results assessing Number and percentage (%) of physicians

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

Regeneron Pharmaceuticals

Registry information

Official study title

Evaluation of Physician Knowledge of Key Safety Information for Eylea in Canada: An Observational Postauthorization Safety Study

Important dates

Study start: 2016
Primary completion: 2016
Study completion: 2016
First posted: Oct 23, 2015
Registry last updated: Mar 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Enrolling by Invitation