Overview

This trial is active, not recruiting.

Condition wet age-related macular degeneration
Treatment aflibercept (eylea, vegf trap-eye, bay86-5321)
Sponsor Bayer
Start date July 2013
End date March 2017
Trial size 988 participants
Trial identifier NCT01914380, 16623, EY1313DE

Summary

The study aims to investigate the effectiveness of Eylea in patients with wet age-related macular degeneration in routine clinical practice in Germany. The study is purely observational, only data from routine treatment are to be collected. The treatment and treatment conditions are solely at discretion of the treating physician.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
aflibercept (eylea, vegf trap-eye, bay86-5321)
Patients will be followed-up for 24 months

Primary Outcomes

Measure
Mean change of visual acuity for the total patient population
time frame: Baseline, 12 and 24 months
Mean change of visual acuity for the subgroup of pretreated patients
time frame: Baseline, 12 and 24 months
Mean change of visual acuity for the subgroup of non-pretreated patients
time frame: Baseline, 12 and 24 months

Secondary Outcomes

Measure
Monitoring of disease activity
time frame: after 12 and 24 months
Monitoring of treatment patterns
time frame: after 12 and 24 months
Mean time from indication of Eylea-treatment by the treating physician to start of treatment
time frame: after 12 and 24 months

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - Patients with wet wAMD treated with Eylea (in accordance with the local Summary of Product Characteristics, SPC). - Written informed consent. Exclusion Criteria: - Exclusion criteria as listed in the local SPC. - Scar, fibrosis, or atrophy involving the center of the fovea in the study eye. - Any concomitant therapy with another agent to treat wet AMD in the study eye.

Additional Information

Official title PERSEUS - A Prospective Non-interventional Study to Assess the Effectiveness of Aflibercept (Eylea®) in Routine Clinical Practice in Patients With Wet Age-related Macular Degeneration
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Bayer.