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

March 27, 2018 updated by: Bayer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

988

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Multiple Locations, Germany

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
Patients will be followed-up for 24 months

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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"
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
after 12 and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Collaborators

Regeneron Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 29, 2013

Primary Completion (Actual)

March 31, 2017

Study Completion (Actual)

March 31, 2017

Study Registration Dates

First Submitted

July 23, 2013

First Submitted That Met QC Criteria

July 31, 2013

First Posted (Estimate)

August 2, 2013

Study Record Updates

Last Update Posted (Actual)

March 29, 2018

Last Update Submitted That Met QC Criteria

March 27, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16623
  • EY1313DE (Other Identifier: Company internal)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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