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
|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)|
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 Type :||Observational|
|Actual Enrollment :||99 participants|
|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|
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.
- 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.
- Investigation whether physicians have received the educational materials [ Time Frame: up to 6 month ]Descriptive results assessing Number and percentage (%) of physicians
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
|Many Locations, Canada|
|Study Director:||Bayer Study Director||Bayer|