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Das Wirkprofil von Faricimab wurde bislang haupts\u00e4chlich unter pivotalen klinischen Phase-3-Studienbedingungen bei therapienaiven Patienten mit nAMD untersucht. Die prospektive, multizentrische, nichtinterventionelle Studie (NIS) PASSENGER tr\u00e4gt dazu bei, die Wirksamkeit, Sicherheit und den Einfluss von Faricimab auf die Lebensqualit\u00e4t bei vorbehandelten Patienten mit nAMD unter Real-World-Bedingungen in Deutschland besser zu verstehen.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Methodik<\/jats:title>\n            <jats:p>Die geplante Beobachtungsdauer pro Patient betr\u00e4gt 24\u00a0Monate. Eingeschlossen werden Patienten (<jats:italic>n<\/jats:italic>\u202f=\u2009620) \u2265\u202f50\u00a0Jahre mit nAMD, die maximal 12\u00a0Wochen vor Studieneinschluss auf Faricimab umgestellt wurden, zuvor maximal 36\u00a0Monate mit einem vaskul\u00e4ren endothelialen Wachstumsfaktor(VEGF)-Inhibitor behandelt wurden und zu Therapiebeginn mit Faricimab eine bestkorrigierte Sehsch\u00e4rfe (BCVA) von 30 bis 80\u00a0Buchstaben auf der ETDRS-Skala aufweisen. Prim\u00e4rer Studienendpunkt ist die BCVA-Ver\u00e4nderung gegen\u00fcber dem Ausgangswert nach 52\u00a0Wochen. Zudem werden die zentrale Netzhautdicke, intraretinale, subretinale und subpigmentepitheliale Fl\u00fcssigkeit im Zeitverlauf sowie patientenberichtete Parameter, Adh\u00e4renz und unerw\u00fcnschte Ereignisse erfasst.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Ergebnis<\/jats:title>\n            <jats:p>Der erste Patient wurde im Juni 2023 eingeschlossen. Der aktuelle Zeitplan sieht die Rekrutierung (24\u00a0Monate) bis Juni 2025 und die letzte Visite des letzten Patienten f\u00fcr Q2\/2027 vor.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Diskussion<\/jats:title>\n            <jats:p>Die Daten der PASSENGER-Studie sollen zum besseren Verst\u00e4ndnis des Therapiemanagements im Praxisalltag in Deutschland beitragen.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Graphic abstract<\/jats:title>\n          <\/jats:sec>","DOI":"10.1007\/s00347-025-02258-y","type":"journal-article","created":{"date-parts":[[2025,5,21]],"date-time":"2025-05-21T07:21:15Z","timestamp":1747812075000},"page":"693-699","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Faricimab bei vorbehandelter neovaskul\u00e4rer altersabh\u00e4ngiger Makuladegeneration (nAMD)","Faricimab in previously treated neovascular age-related macular degeneration"],"prefix":"10.1007","volume":"122","author":[{"given":"Britta","family":"Heimes-Bussmann","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rooschanak","family":"Bellenbaum","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Christian","family":"Njoo","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sandra","family":"Liakopoulos","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Steffen","family":"Schmitz-Valckenberg","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Max","family":"Zortel","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kai","family":"Rothaus","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jost","family":"Leemhuis","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Peter","family":"Mussinghoff","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9640-4103","authenticated-orcid":false,"given":"Albrecht","family":"Lommatzsch","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2025,5,21]]},"reference":[{"key":"2258_CR1","doi-asserted-by":"crossref","unstructured":"Aljundi W, Daas L, Suffo S et\u00a0al (2024) First-Year Real-Life Experience with Intravitreal Faricimab for Refractory Neovascular Age-Related Macular Degeneration. 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R.\u00a0Bellenbaum, C.\u00a0Njoo, M.\u00a0Zortel und J.\u00a0Leemhuis sind Angestellte der Roche Pharma AG. S.\u00a0Liakopoulos: Allergan\/AbbVie, Apellis, Astellas, Bayer, Biogen, Janssen (Berater); Allergan\/AbbVie, Apellis, Astellas, Bayer, Biogen, Heidelberg Engineering, Novartis, Roche, Zeiss (Referentenhonorar); Novartis, Roche (Forschungsunterst\u00fctzung). S.\u00a0Schmitz-Valckenberg: Apellis, Heidelberg Engineering, Roche (Referenten\u2011\/Beratungshonorar); AlphaRET, Apellis, eyeDNA, Formycon, Galimedix, Carl Zeiss Meditec, Heidelberg Eningeering, Katairo, Novartis, Perceive Therapeutics, Pixium, Roche, Sparing Vision (Studienteilnahme). P.\u00a0Mussinghoff: Carl Zeiss Meditec (Referentent\u00e4tigkeit). A.\u00a0Lommatzsch: Roche, Bayer, Novartis, Zeiss, Biogene (Referentent\u00e4tigkeit und Adboard). K.\u00a0Rothaus gibt an, dass kein Interessenkonflikt besteht.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Interessenkonflikt"}},{"value":"Alle beschriebenen Untersuchungen am Menschen wurden mit Zustimmung der zust\u00e4ndigen Ethikkommission, im Einklang mit nationalem Recht sowie gem\u00e4\u00df der Deklaration von Helsinki von 1975 (in der aktuellen, \u00fcberarbeiteten Fassung) durchgef\u00fchrt. Von allen beteiligten Patienten liegt eine Einverst\u00e4ndniserkl\u00e4rung vor.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Interessenkonflikt"}}]}}