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

NCT ID: NCT02585401

Last Updated: 2017-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

99 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-02-18

Study Completion Date

2016-05-19

Brief Summary

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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

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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

Conditions

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Age-related Macular Degeneration (AMD) Central Retinal Vein Occlusion (CRVO) Diabetic Macular Edema (DME)

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Eylea product and application information / Cohort 1

Physicians prescribing aflibercept in Canada will be selected to reflect the distribution of retinal specialists and ophthalmologists who prescribe aflibercept.

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

Intervention Type 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.

Interventions

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

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.

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Many Locations, , Canada

Site Status

Countries

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Canada

Other Identifiers

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18498

Identifier Type: -

Identifier Source: org_study_id

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