check_circleStudy Completed

Macular Degeneration

Bayer Identifier:

16526

ClinicalTrials.gov Identifier:

NCT02615496

EudraCT Number:

Not Available

EU CT Number:

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

Trial purpose

The study will be an observational, cross-sectional study of knowledge, understanding, and self-reported behavior among a sample of physicians and patients with recent aflibercept experience in a total of up to five European countries.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • Physicians eligibility:
    - Licensed and practicing ophthalmologist
    - Prescribed and administered aflibercept to at least one patient in the past 6 months
    Patients eligibility:
    - Patient has been administered aflibercept at least once within the last 6 months for any indication and is returning for a subsequent visit.
    - Patient is aged 18 years or older.
    - Patient is able to understand and sign the consent form and patient questionnaire.
    - Patient can understand the native language of the country in which the study is being conducted.
    - Patient has not participated in a clinical trial for the treatment of an aflibercept indication (e.g., wAMD, CRVO, or DME) in the past 12 months.

Trial summary

Enrollment Goal
716
Trial Dates
December 2015 - January 2017
Phase
Phase 4
Could I Receive a placebo
No
Products
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, United Kingdom
Completed
Many Locations, Germany
Completed
Many Locations, France
Completed
Many Locations, Spain
Completed
Many Locations, Italy

Primary Outcome

  • The proportion of physicians with accurate knowledge and understanding of key safety information (identified risks and prescribing behaviors) contained in the Eylea educational materials as assessed by a study specific questionnaire.
    date_rangeTime Frame:
    Up to 2 years
    enhanced_encryption
    Safety Issue:
    No
  • The proportion of patients with accurate knowledge and understanding of key safety information (identified risks and guidelines) contained in the Eylea educational materials as assessed by a study specific interviewer administered questionnaire.
    date_rangeTime Frame:
    Up to 2 years
    enhanced_encryption
    Safety Issue:
    No

Trial design

Evaluation of Physician and Patient Knowledge of Safety and Safe Use Information for Aflibercept in Europe: An Observational Postauthorisation Study
Trial Type
Observational
Intervention Type
Behavioral
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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