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

Macular Degeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02615496
• Other study ID #: 16526
• Secondary ID: EY1301
• Status: Completed
• Phase: N/A
• First received: October 21, 2015
• Last updated: September 14, 2017
• Start date: December 7, 2015
• Est. completion date: January 31, 2017

Study information

• Verified date: September 2017
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 716
• Est. completion date: January 31, 2017
• Est. primary completion date: September 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Macular Degeneration

Intervention

Behavioral:
• Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
Survey to measure physician awareness and understanding of the key messages in the educational materials: the prescriber guide and video.
• Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
Survey to measure patient awareness and understanding of the key messages in the educational materials: the patient booklet "Your guide to EYLEA," patient information leaflet, and audio CD.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	RTI Health Solutions

Countries where clinical trial is conducted

France,  Germany,  Italy,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Up to 2 years
Primary	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.		Up to 2 years

External Links

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