Aflibercept (Eylea) in roUtine Clinical Practice in patientS With Wet Age-related Macular Degeneration in Italy (PERSEUS-IT)

November 3, 2023 updated by: Bayer

PERSEUS-IT. A Prospective Non-intERventional Study to asSEss the Effectiveness of Aflibercept (Eylea®) in roUtine Clinical Practice in patientS With Wet Age-related Macular Degeneration in Italy

The main objectives of this non-interventional cohort field study are to evaluate effectiveness of Eylea and to describe follow-up as well as treatment patterns in patients with wAMD (wet age-related macular degeneration) in routine clinical practice in Italy for a study population of "naïve" patients

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

912

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

  • Italy
      • Multiple Locations, Italy

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

Sampling Method

Non-Probability Sample

Study Population

wet AMD (wet age-related macular degeneration) patients

Description

Inclusion Criteria:

  • "Naïve" patients with wet AMD(age-related macular degeneration) treated with Eylea (in accordance with the local Summary of Product Characteristics, SPC).

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.
  • Any prior or concomitant therapy with another drug for wAMD.

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
Cohort 1
According to the recommendations of the Summary of Product Characteristics (SmPC) in Italy
Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
Administration by intravitreal injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean change of visual acuity from baseline to 24 months.
Time Frame: Baseline to 24 months
Baseline to 24 months
Mean change of visual acuity from baseline to 12 months.
Time Frame: Baseline to 12 months
Baseline to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of clinical visits (visits for injections)
Time Frame: At 12 and 24 months
At 12 and 24 months
Number of monitoring visits (visits only for diagnostic purposes, but without injections)
Time Frame: At 12 and 24 months
At 12 and 24 months
Number of combined visits (visits for monitoring and injection)
Time Frame: At 12 and 24 months
At 12 and 24 months
Number of post-injection monitoring visits (visits only for safety checks after injection)
Time Frame: At 12 and 24 months
At 12 and 24 months
Number of visits outside the study center after 12 and 24 months
Time Frame: At 12 and 24 months
At 12 and 24 months
Number of optical coherence tomography (OCT) assessments per patient
Time Frame: At 12 and 24 months
At 12 and 24 months
Number of visual acuity tests
Time Frame: At 12 and 24 months
At 12 and 24 months
Number of fundoscopy examinations
Time Frame: At 12 and 24 months
At 12 and 24 months
Mean time between the injections and visits
Time Frame: At 12 and 24 months
At 12 and 24 months
Mean time between the first symptoms and diagnosis
Time Frame: Up to 24 months
Up to 24 months
Mean time from indication of the Eylea treatment by the treating physician to treatment
Time Frame: Up to 24 months
Time will be defined as difference in days between clinical indication for the treatment and the first injection
Up to 24 months
Proportion of patients with no fluid
Time Frame: At 4,12 and 24 months
At 4,12 and 24 months
Mean change in retinal thickness from baseline
Time Frame: Baseline and at 4,12 and 24 months
As measured by OCT (SD-SLO) Optical Coherence Tomography ( Spectral Domain / Scanning Laser Ophthalmoscope)
Baseline and at 4,12 and 24 months

Collaborators and Investigators

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

Sponsor

Bayer

Collaborators

Regeneron Pharmaceuticals

Investigators

  • Study Director: Bayer Study Director, Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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)

January 9, 2015

Primary Completion (Actual)

March 28, 2019

Study Completion (Actual)

July 8, 2019

Study Registration Dates

First Submitted

November 10, 2014

First Submitted That Met QC Criteria

November 10, 2014

First Posted (Estimated)

November 13, 2014

Study Record Updates

Last Update Posted (Actual)

November 7, 2023

Last Update Submitted That Met QC Criteria

November 3, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17634
  • EY1415IT (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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