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

Age-related Macular Degeneration (AMD) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02585401
• Other study ID #: 18498
• Status: Completed
• Phase: N/A
• First received: October 22, 2015
• Last updated: March 20, 2017
• Start date: February 18, 2016
• Est. completion date: May 19, 2016

Study information

• Verified date: March 2017
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: May 19, 2016
• Est. primary completion date: March 31, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Regeneron Pharmaceuticals

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The source of information for the study will be self-reported data collected from physicians using standard questionnaires with closed-ended response choices.	Up to 8 weeks after the start of data collection
Secondary	Investigation whether physicians have received the educational materials	Descriptive results assessing Number and percentage (%) of physicians	up to 6 month

External Links

•   Click here and search for drug information provided by the FDA.
•   Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.