Clinical trial NCT02289924: Aflibercept (Eylea) in roUtine Clinical Practice in patientS With Wet Age-related Macular Degeneration in Italy
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Wet Macular Degeneration
Keywords: wet AMD
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2014-11-13
Enrollment: 912
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: wet AMD (wet age-related macular degeneration) patients

Brief summary: 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


Eligibility criteria: 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.

Primary outcomes:
measure: Mean change of visual acuity from baseline to 12 months.
timeFrame: Baseline to 12 months
measure: Mean change of visual acuity from baseline to 24 months.
timeFrame: Baseline to 24 months
Secondary outcomes:
measure: Number of clinical visits (visits for injections)
timeFrame: At 12 and 24 months
measure: Number of monitoring visits (visits only for diagnostic purposes, but without injections)
timeFrame: At 12 and 24 months
measure: Number of combined visits (visits for monitoring and injection)
timeFrame: At 12 and 24 months
measure: Number of post-injection monitoring visits (visits only for safety checks after injection)
timeFrame: At 12 and 24 months
measure: Number of visits outside the study center after 12 and 24 months
timeFrame: At 12 and 24 months
measure: Number of optical coherence tomography (OCT) assessments per patient
timeFrame: At 12 and 24 months
measure: Number of visual acuity tests
timeFrame: At 12 and 24 months
measure: Number of fundoscopy examinations
timeFrame: At 12 and 24 months
measure: Mean time between the injections and visits
timeFrame: At 12 and 24 months
measure: Mean time between the first symptoms and diagnosis
timeFrame: Up to 24 months
measure: Mean time from indication of the Eylea treatment by the treating physician to treatment
timeFrame: Up to 24 months
measure: Proportion of patients with no fluid
timeFrame: At 4,12 and 24 months
measure: Mean change in retinal thickness from baseline
timeFrame: Baseline and at 4,12 and 24 months
Other outcomes:
Locations:
city: Multiple Locations
country: Italy
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: 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.