NCT02615496

Brief 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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
716

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2015

Geographic Reach
5 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 21, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 26, 2015

Completed
11 days until next milestone

Study Start

First participant enrolled

December 7, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2017

Completed
Last Updated

September 15, 2017

Status Verified

September 1, 2017

Enrollment Period

10 months

First QC Date

October 21, 2015

Last Update Submit

September 14, 2017

Conditions

Macular Degeneration

Keywords

Health Care SurveysVascular Endothelial Growth Factor

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

Educational materials: Physicians

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

Educational materials: Patients

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

Interventions

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.

Educational materials: Physicians

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Unknown Facility

Many Locations, France

Location

Unknown Facility

Many Locations, Germany

Location

Unknown Facility

Many Locations, Italy

Location

Unknown Facility

Many Locations, Spain

Location

Unknown Facility

Many Locations, United Kingdom

Location

MeSH Terms

Conditions

Macular Degeneration

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2015

First Posted

November 26, 2015

Study Start

December 7, 2015

Primary Completion

September 30, 2016

Study Completion

January 31, 2017

Last Updated

September 15, 2017

Record last verified: 2017-09

Locations

GB(1)FR(1)DE(1)ES(1)IT(1)