Trials / Completed
CompletedNCT02585401
Evaluation of Physician Knowledge of Safety and Safe Use Information for Aflibercept in Canada
Evaluation of Physician Knowledge of Key Safety Information for Eylea in Canada: An Observational Postauthorization Safety Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 99 (actual)
- Sponsor
- Bayer · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Accepted
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.
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
Conditions
- Age-related Macular Degeneration (AMD)
- Central Retinal Vein Occlusion (CRVO)
- Diabetic Macular Edema (DME)
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2016-02-18
- Primary completion
- 2016-03-31
- Completion
- 2016-05-19
- First posted
- 2015-10-23
- Last updated
- 2017-03-21
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT02585401. Inclusion in this directory is not an endorsement.