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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02585401
Other study ID # 18498
Secondary ID
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
Health authority
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

Study Design


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
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