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OpenTrials
Completed

NCT Number: NCT02615496

Evaluation of Physician and Patient Knowledge of Safety and Safe Use Information for Aflibercept

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.

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Key information

Conditions

Macular Degeneration Eye Diseases Retinal Degeneration Retinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Treatment and study plan

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

Behavioral

Survey to measure physician awareness and understanding of the key messages in the educational materials: the prescriber guide and video.

Primary outcomes

  1. 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.

    Time frame: Up to 2 years

  2. 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.

    Time frame: Up to 2 years

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • RTI Health Solutions

Registry information

Official study title

Evaluation of Physician and Patient Knowledge of Safety and Safe Use Information for Aflibercept in Europe: An Observational Postauthorisation Study

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Nov 26, 2015
Registry last updated
Sep 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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