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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Wet Macular Degeneration

Intervention / Treatment
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* Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1<br>According to the recommendations of the Summary of Product Characteristics (SmPC) in Italy | Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)<br>* Administration by intravitreal injection<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of clinical visits (visits for injections) |  | At 12 and 24 months | 
| Number of monitoring visits (visits only for diagnostic purposes, but without injections) |  | At 12 and 24 months | 
| Number of combined visits (visits for monitoring and injection) |  | At 12 and 24 months | 
| Number of post-injection monitoring visits (visits only for safety checks after injection) |  | At 12 and 24 months | 
| Number of visits outside the study center after 12 and 24 months |  | At 12 and 24 months | 
| Number of optical coherence tomography (OCT) assessments per patient |  | At 12 and 24 months | 
| Number of visual acuity tests |  | At 12 and 24 months | 
| Number of fundoscopy examinations |  | At 12 and 24 months | 
| Mean time between the injections and visits |  | At 12 and 24 months | 
| Mean time between the first symptoms and diagnosis |  | Up to 24 months | 
| Mean time from indication of the Eylea treatment by the treating physician to treatment | 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 |  | At 4,12 and 24 months | 
| Mean change in retinal thickness from baseline | As measured by OCT (SD-SLO) Optical Coherence Tomography ( Spectral Domain / Scanning Laser Ophthalmoscope) | Baseline and at 4,12 and 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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wet AMD