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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: March 31, 2017

Interventions

  • Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
    • Patients will be followed-up for 24 months

Arms, Groups and Cohorts

  • Group 1

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Monitoring of disease activity
    • Time Frame: after 12 and 24 months
    • Monitoring 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 patterns
    • Time Frame: after 12 and 24 months
    • same assessment as indicated for “Monitoring of disease activity”
  • Mean time from indication of Eylea-treatment by the treating physician to start of treatment
    • Time Frame: after 12 and 24 months

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Bayer
  • Collaborator
    • Regeneron Pharmaceuticals
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Bayer Study Director, Study Director, Bayer

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