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

Overview

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

Full Title of Study: “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”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: March 28, 2019

Interventions

  • Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
    • Administration by intravitreal injection

Arms, Groups and Cohorts

  • Cohort 1
    • According to the recommendations of the Summary of Product Characteristics (SmPC) in Italy

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Number of clinical visits (visits for injections)
    • Time Frame: At 12 and 24 months
  • Number of monitoring visits (visits only for diagnostic purposes, but without injections)
    • Time Frame: At 12 and 24 months
  • Number of combined visits (visits for monitoring and injection)
    • Time Frame: 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
  • Number of visits outside the study center after 12 and 24 months
    • Time Frame: At 12 and 24 months
  • Number of optical coherence tomography (OCT) assessments per patient
    • Time Frame: At 12 and 24 months
  • Number of visual acuity tests
    • Time Frame: At 12 and 24 months
  • Number of fundoscopy examinations
    • Time Frame: At 12 and 24 months
  • Mean time between the injections and visits
    • Time Frame: At 12 and 24 months
  • Mean time between the first symptoms and diagnosis
    • Time Frame: 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
  • Proportion of patients with no fluid
    • Time Frame: 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)

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

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

Citations Reporting on Results

Nicolo M, Ciucci F, Nardi M, Parolini B, Russo A, Scupola A, Torregrossa S, Vadala M; PERSEUS-IT study investigators. PERSEUS-IT 24-month analysis: a prospective observational study to assess the effectiveness of intravitreal aflibercept in routine clinical practice in Italy in patients with neovascular age-related macular degeneration. Graefes Arch Clin Exp Ophthalmol. 2022 Oct;260(10):3185-3195. doi: 10.1007/s00417-022-05679-6. Epub 2022 May 5.

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