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

Bayer

Status: Completed

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

Treatments: Drug: Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)

Study type: Observational

Funder types: Industry

Identifiers

NCT02585401

18498

Details and patient eligibility

About

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.

Full 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

Enrollment: 99 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

99 participants in 1 patient group

Eylea product and application information / Cohort 1

Description:

Physicians prescribing aflibercept in Canada will be selected to reflect the distribution of retinal specialists and ophthalmologists who prescribe aflibercept.

Treatment:

Drug: Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)