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

Completed

• Conditions: Central Retinal Vein Occlusion (CRVO); Age-related Macular Degeneration (AMD); Diabetic Macular Edema (DME)
• Interventions: Drug: Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)

• Registration Number: NCT02585401
• Lead Sponsor: Bayer

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2015-10-22
• Study First Submitted QC: 2015-10-22
• Study First Posted: 2015-10-23
• Study Start: 2016-02-18
• Primary Completion: 2016-03-31
• Study Completion: 2016-05-19
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-20
• Last Update Posted: 2017-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

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.

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Exclusion Criteria

• None applied

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Eylea product and application information / Cohort 1	Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)	Physicians prescribing aflibercept in Canada will be selected to reflect the distribution of retinal specialists and ophthalmologists who prescribe aflibercept.

Primary Outcome Measures

Name	Time	Method
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	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 Outcome Measures

Name	Time	Method
Investigation whether physicians have received the educational materials	up to 6 month	Descriptive results assessing Number and percentage (%) of physicians