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| ID | Type | Description | Link |
|---|---|---|---|
| EY1415IT | Other Identifier | Company Internal |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | According to the recommendations of the Summary of Product Characteristics (SmPC) in Italy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) | Drug | Administration by intravitreal injection |
|
| 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 |
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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wet AMD (wet age-related macular degeneration) patients
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multiple Locations | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35511286 | Result | 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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| ID | Term |
|---|---|
| D057135 | Wet Macular Degeneration |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C533178 | aflibercept |
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| 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 |