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Investigating the Effectiveness of Eylea in Patients With Wet Age-related Macular Degeneration

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01914380
Acronym
PERSEUS
Enrollment
988
Registered
2013-08-02
Start date
2013-07-29
Completion date
2017-03-31
Last updated
2018-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Wet Age-related Macular Degeneration

Keywords

Wet age-related macular degeneration, Anti-VEGF-Therapy, Observational study

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.

Interventions

DRUGAflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)

Patients will be followed-up for 24 months

Sponsors

Regeneron Pharmaceuticals
CollaboratorINDUSTRY
Bayer
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Patients with wet wAMD treated with Eylea (in accordance with the local Summary of Product Characteristics, SPC). * Written informed consent.

Exclusion criteria

*

Design outcomes

Primary

MeasureTime frame
Mean change of visual acuity for the total patient populationBaseline, 12 and 24 months
Mean change of visual acuity for the subgroup of pretreated patientsBaseline, 12 and 24 months
Mean change of visual acuity for the subgroup of non-pretreated patientsBaseline, 12 and 24 months

Secondary

MeasureTime frameDescription
Monitoring of disease activityafter 12 and 24 monthsMonitoring of disease activity in routine clinical practice setting will be assessed e.g. by determining the o No. of clinical visits (visits for injections) o No. of monitoring visits (visits only for diagnostic purposes, but without injections) o No. of safety visits after the injection (visits only for safety checks after injection) o No. of visits outside the study center o No. of OCT (optical coherence tomography) assessments per patient after 12 and 24 months
Monitoring of treatment patternsafter 12 and 24 monthssame assessment as indicated for Monitoring of disease activity
Mean time from indication of Eylea-treatment by the treating physician to start of treatmentafter 12 and 24 months

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026