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CompletedNCT02615496Updated Sep 15, 2017

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

An observational study in Macular Degeneration, sponsored by Bayer. Completed at 5 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-09-15.

Sponsored by Bayer · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
716
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Macular Degeneration

Keywords

  • Health Care Surveys
  • Vascular Endothelial Growth Factor
03

In context

Macular Degeneration

1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.

This study's enrollment of 716 is above the median of 106 across 421 observational studies indexed under Macular Degeneration.

Browse Macular Degeneration studies →

Lead sponsor

Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.

Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Physicians eligible to participate will be ophthalmologists who have administered aflibercept in the past 6 months.

Patients eligible to participate will be those who have already received at least one aflibercept injection and are returning for a subsequent visit. Patients will be aged 18 years or older, and will be able to understand the native language of the country in which the study is conducted.

Eligibility criteria

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.
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
716 participants (actual)

Groups and cohorts

  • Educational materials: Physicians

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

  • Educational materials: Patients

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

Interventions

  • BehavioralAflibercept (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.

  • BehavioralAflibercept (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.

06

What researchers measure

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

07

Study locations

5 sites
  • Many Locations, France
  • Many Locations, Germany
  • Many Locations, Italy
  • Many Locations, Spain
  • Many Locations, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 15, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02615496
Lead sponsor
Bayer
Collaborators
RTI Health Solutions
Responsible party
Sponsor
First posted
Nov 26, 2015
Start date
Dec 7, 2015
Primary completion
Sep 30, 2016
Completion
Jan 31, 2017
Last update
Sep 15, 2017

Study contacts

Bayer Study Director
study director · Bayer

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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