Studiencode: CRTH258A2402
| Institution: | Novartis Pharma GmbH | ||
| Titel der NIS: | A non-interventional study to assess the influence of automated optical coherence tomography (OCT) image enrichment with segmentation information on disease activity assessment in patients treated with licensed anti-VEGF injections (RAZORBILL) | ||
| Ziel der NIS: | The primary research question to be addressed by this study is: Does automated OCT image enrichment with segmentation information influence disease activity assessment in patients treated with licensed anti-VEGF injections for nAMD? |
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| Ort der Durchführung: | multinational | NIS angefordert: | nein |
| Patientenanzahl insgesamt: | 476 | Anzahl Ärzte insgesamt: | 17 |
| Patientenanzahl in Deutschland: | 181 | Ärzte in Deutschland: | 6 |
| Anzeige am: | 16.02.2021 | Geplanter Beginn: | 23.02.2021 | Geplantes Ende: | 21.06.2023 |
| Angezeigtes Ende der NIS am: 21.06.2023 | |||||
| Arzneimittelbezeichnung | INN | Zulassungs-Nr. | ATC-Code | Substanzklasse |
|---|---|---|---|---|
| All licensed anti-VEGF injections: | ||||
| Beovu | Brolucizumab | EU/1/19/1417/001-002 | S01LA06 | anti-VEGF |
| Lucentis | Ranibizumab | EU/1/06/374/002, EU/1/06/374/004 | S01LA04 | anti-VEGF |
| Eylea | Aflibercept | EU/1/12/797/002 | S01LA05 | anti-VEGF |
