check_circleStudy Completed

Age-related macular degeneration (AMD), Central retinal vein occlusion (CRVO), Diabetic Macular Edema (DME)

Bayer Identifier:

18498

ClinicalTrials.gov Identifier:

NCT02585401

EudraCT Number:

Not Available

EU CT Number:

Not Available
Evaluation of Physician Knowledge of Safety and Safe Use Information for Aflibercept in Canada

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

NaN - N/A
  • 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.

  • - None applied

Trial summary

Enrollment Goal
99
Trial Dates
February 2016 - May 2016
Phase
N/A
Could I Receive a placebo
No
Products
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Canada

Primary Outcome

  • 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.
    date_rangeTime Frame:
    Up to 8 weeks after the start of data collection
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Investigation whether physicians have received the educational materials
    Descriptive results assessing Number and percentage (%) of physicians
    date_rangeTime Frame:
    up to 6 month
    enhanced_encryption
    Safety Issue:
    No

Trial design

Evaluation of Physician Knowledge of Key Safety Information for Eylea in Canada: An Observational Postauthorization Safety Study
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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