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Completed

NCT Number: NCT02289924

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

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Key information

Conditions

Wet Macular Degeneration Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Multiple Locations, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Drug

Administration by intravitreal injection

Primary outcomes

  1. Mean change of visual acuity from baseline to 12 months.

    Time frame: Baseline to 12 months

  2. Mean change of visual acuity from baseline to 24 months.

    Time frame: Baseline to 24 months

Secondary outcomes

  1. Number of clinical visits (visits for injections)

    Time frame: At 12 and 24 months

  2. Number of monitoring visits (visits only for diagnostic purposes, but without injections)

    Time frame: At 12 and 24 months

  3. Number of combined visits (visits for monitoring and injection)

    Time frame: At 12 and 24 months

  4. Number of post-injection monitoring visits (visits only for safety checks after injection)

    Time frame: At 12 and 24 months

  5. Number of visits outside the study center after 12 and 24 months

    Time frame: At 12 and 24 months

  6. Number of optical coherence tomography (OCT) assessments per patient

    Time frame: At 12 and 24 months

  7. Number of visual acuity tests

    Time frame: At 12 and 24 months

  8. Number of fundoscopy examinations

    Time frame: At 12 and 24 months

  9. Mean time between the injections and visits

    Time frame: At 12 and 24 months

  10. Mean time between the first symptoms and diagnosis

    Time frame: Up to 24 months

  11. 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

  12. Proportion of patients with no fluid

    Time frame: At 4,12 and 24 months

  13. 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)

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Acronym: PERSEUS-IT

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Nov 13, 2014
Registry last updated
Nov 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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