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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02585401
Recruitment Status : Completed
First Posted : October 23, 2015
Last Update Posted : March 21, 2017
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Bayer

Study Description
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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.

Condition or disease Intervention/treatment
Age-related Macular Degeneration (AMD) Central Retinal Vein Occlusion (CRVO) Diabetic Macular Edema (DME) Drug: Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)

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 Design
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Study Type : Observational
Actual Enrollment : 99 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Evaluation of Physician Knowledge of Key Safety Information for Eylea in Canada: An Observational Postauthorization Safety Study
Actual Study Start Date : February 18, 2016
Actual Primary Completion Date : March 31, 2016
Actual Study Completion Date : May 19, 2016

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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.
 Drug: 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Investigation whether physicians have received the educational materials [ Time Frame: up to 6 month ]
    Descriptive results assessing Number and percentage (%) of physicians


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Physicians prescribing aflibercept in Canada will be selected to reflect the distribution of retinal specialists and ophthalmologists who prescribe aflibercept.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02585401


Locations
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Canada
Many Locations, Canada
Sponsors and Collaborators
Bayer
Regeneron Pharmaceuticals
Investigators
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Study Director: Bayer Study Director Bayer
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02585401    
Other Study ID Numbers: 18498
First Posted: October 23, 2015    Key Record Dates
Last Update Posted: March 21, 2017
Last Verified: March 2017
Additional relevant MeSH terms:
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Macular Degeneration
Macular Edema
Retinal Vein Occlusion
Retinal Degeneration
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
 Vascular Diseases
Cardiovascular Diseases
Aflibercept
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents