Nicht-interventionelle Studie (Anwendungsbeobachtung) NIS-Nr.: 556
Studiencode: CRTH258ADE02
Allgemeine Angaben
Institution: |
Novartis Pharma GmbH |
|
|
Titel der NIS: |
OBservationaL stUdy to Evaluate fluid reSolution and effectiveness in patients receiving Beovu (brolucizumab) under KeY treatment schemes in neovascular age-related macular degeneration and visual impairment due to diabetic macular edema |
Ziel der NIS: |
Primary objectives and endpoints:
nAMD:
1. Evaluate fluid resolution after initiation of brolucizumab (AMD module)
Endpoint: Percentage (%) of patients eyes that are absent of SRF and IRF at month 12
This primary study objective will be addressed considering treatment naïve and switch patient eyes included in the study, analyzed as two independent groups (naïve and switch).
2. Evaluate effectiveness (functional, morphological) of brolucizumab under clinic specific treatment schemes in real life (BIRL module)
Endpoints:
• Mean change in visual actuity (VA) at month 12 compared to baseline under clinic specific routine treatment schemes
• Morphological CNV-Changes at month 12 compared to baseline under clinic specific routine treatment schemes
This primary study objective will be addressed considering treatment naïve patient eyes, only.
DME:
Evaluate effectiveness of brolucizumab by characterizing treatment patterns in DME
patients during first year of brolucizumab treatment
Endpoint:
Naïve patients:
Percent of patients maintained on q12w dosing after loading through Week 52 (12 months)
Switch patients:
Change in interval length from last interval before switch (“baseline”) to last interval at end of
follow-up (12 months)
|
Ort der Durchführung: |
nur Deutschland |
NIS angefordert: |
nein |
Patientenanzahl insgesamt: |
573 |
Anzahl Ärzte insgesamt: |
51 |
Patientenanzahl in Deutschland: |
573 |
Ärzte in Deutschland: |
51 |
Weitere Angaben und Unterlagen
Anzeige am: |
20.10.2020 |
Geplanter Beginn: |
31.10.2020 |
Geplantes Ende: |
16.10.2023 |
Angezeigtes Ende der NIS am: nicht vorhanden |
Angaben zu den beobachteten Arzneimitteln, soweit angezeigt
Arzneimittelbezeichnung |
INN |
Zulassungs-Nr. |
ATC-Code |
Substanzklasse |
Beovu |
Brolucizumab |
EU/1/19/1417/001-002 |
S01LA06 |
Brolucizumab |
Verfügbare Dokumente
Art des Dokuments |
|
Beobachtungsplan, NIS 556 |
pdf 596KB |