Investigating the Effectiveness of Eylea in Patients With Wet Age-related Macular Degeneration
PERSEUS
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
2 other identifiers
observational
988
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2013
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 23, 2013
CompletedStudy Start
First participant enrolled
July 29, 2013
CompletedFirst Posted
Study publicly available on registry
August 2, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2017
CompletedMarch 29, 2018
March 1, 2018
3.7 years
July 23, 2013
March 27, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Mean change of visual acuity for the total patient population
Baseline, 12 and 24 months
Mean change of visual acuity for the subgroup of pretreated patients
Baseline, 12 and 24 months
Mean change of visual acuity for the subgroup of non-pretreated patients
Baseline, 12 and 24 months
Secondary Outcomes (3)
Monitoring of disease activity
after 12 and 24 months
Monitoring of treatment patterns
after 12 and 24 months
Mean time from indication of Eylea-treatment by the treating physician to start of treatment
after 12 and 24 months
Study Arms (1)
Group 1
Interventions
Eligibility Criteria
The study population will consist of patients with wAMD treated with Eylea. Participants will be recruited from ophthalmological clinics and practices throughout Germany. The decision upon treatment is made at the discretion of the attending physician, according to his/her medical practice. The medication is prescribed at regular visits to the investigator's office. Commercially available product will be used to treat the patients.
You may qualify if:
- Patients with wet wAMD treated with Eylea (in accordance with the local Summary of Product Characteristics, SPC).
- Written informed consent.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
- Regeneron Pharmaceuticalscollaborator
Study Sites (1)
Unknown Facility
Multiple Locations, Germany
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 23, 2013
First Posted
August 2, 2013
Study Start
July 29, 2013
Primary Completion
March 31, 2017
Study Completion
March 31, 2017
Last Updated
March 29, 2018
Record last verified: 2018-03