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Prospektive nichtinterventionelle BLUE SKY-Studie zur Beurteilung der Wirksamkeit von Brolucizumab bei unbehandelten und vorbehandelten Patienten mit neovaskulärer AMD

Prospective noninterventional BLUE SKY study evaluating the efficacy of brolucizumab in treatment-naïve and previously treated patients with neovascular AMD

Zusammenfassung

Die intravitreale Anti-VEGF(„vascular endothelial growth factor“)-Injektion stellt die Standardtherapie bei Patienten mit neovaskulärer altersabhängiger Makuladegeneration (nAMD) dar. Neben den zugelassenen Wirkstoffen Ranibizumab (Lucentis®, Novartis) und Aflibercept (Eylea®, Bayer) steht auch Bevacizumab (Avastin®, Roche) zur Verfügung. Seit April 2020 ist zusätzlich Brolucizumab (Beovu®, Novartis) in Deutschland zugelassen und verfügbar. Diese multizentrische, nichtinterventionelle prospektive BLUE SKY-Studie untersucht die Brolucizumab-Therapie mit verschiedenen Behandlungskonzepten im klinischen Alltag bei 600 behandlungsnaiven und vorbehandelten nAMD-Patienten über eine Dauer von 24 Monaten. Neben allgemeinen Patientendaten werden Visus und Behandlungsdaten dokumentiert. Fluoreszenzangiographie, Fundusfotografie, Spectral-Domain-optische Kohärenztomographie und Swept-Source-optische Kohärenztomographie-Angiographie werden durchgeführt und durch Reading-Center analysiert. Das Hauptaugenmerk der Analyse liegt dabei auf der intra- und subretinalen Flüssigkeitsverteilung sowie den MNV-Veränderungen sowie der Injektionsfrequenz. Die Sicherheit und unerwünschte Arzneimittelwirkungen von Brolucizumab sollen erfasst werden mit spezifischem Fokus auf inflammatorische Komplikationen, insbesondere eine retinale (okklusive) Vaskulitis.

Abstract

Intravitreal injection of anti-vascular endothelial growth factor (VEGF) is the standard treatment for patients with neovascular age-related macular degeneration (nAMD). In addition to the approved substances ranibizumab (Lucentis®, Novartis) and aflibercept (Eylea®, Bayer), bevacizumab (Avastin®, Roche) is also available. Furthermore, brolucizumab (Beovu®, Novartis) has been approved and has been available in Germany since April 2020. The multicenter, noninterventional prospective BLUE SKY study investigates brolucizumab treatment with different schemes in 600 treatment-naive and pretreated nAMD patients in routine clinical practice over a 24-month period. Besides general patient data, visual acuity and treatment data will be documented. Fluorescein angiography, fundus photography, spectral domain optical coherence tomography and swept-source optical coherence tomography angiography will be performed and analyzed by reading centers. The focus of the analysis will be on the intraretinal and subretinal fluid distribution as well as morphological MNV changes and injection frequency. Also, safety and adverse drug effects of brolucizumab, with a specific focus on inflammatory complications, particularly retinal (occlusive) vasculitis will be evaluated.

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Correspondence to D. Pauleikhoff.

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Interessenkonflikt

H. Faatz: Novartis (C, S); Heidelberg Engineering (S). N. Feltgen: Alimera Sciences (C, S), Novartis (C, S), Roche (C, S); Allergan (S), Bayer (S), Heidelberg Engineering (S). M. Gutfleisch: Novartis (F), Bayer (F, R). B. Heimes-Bussmann: Bayer (B). T.U. Krohne: Alimera Sciences (R, C), Allergan (R), Bayer (F, R, C), Heidelberg Engineering (R), Novartis (F, R, C), Roche (R, C). S. Liakopoulos: Consultant: Allergan (C, S), Apellis (C, S), Bayer (C, S), Novartis (C, S), Alcon (S), Heidelberg Engineering (S), Zeiss (S). R. Liegl: Novartis, DORC. A. Lommatzsch: Allergan (R, C), Bayer (R, C), Heidelberg Engineering (R), Novartis (F, R, C), Roche (R). P. Mussinghoff: F: Novartis Pharma GmbH, BMBF; R: OD-OS GmbH. D. Pauleikhoff: Bayer (F, R, C), Heidelberg Engineering (R), Novartis (F, R, C), Roche (R, C). M. Rehak: Alimera Sciences (R, C), Allergan (R, C), Bayer (R, C), Heidelberg Engineering (R), Novartis (F, R, C), Roche (R). S. Schmitz-Valckenberg: Acucela (F), AlphaRET (F), Bioeq/Formycon (F), Carl Zeiss Meditec (F), Heidelberg Engineering (F, R), Katairo, Novartis (F, C), Pixium (C), Roche (F, C), SparingVision. Apellis (C, R). G. Spital: Bayer (R, C), Novartis (F, R, C) Roche (C), Allergan (R). B. Stanzel: Alimera Sciences (R, C), Allergan (R), Bayer (R), Carl Zeiss Meditec (F), Geuder AG (F, R, C, P) Heidelberg Engineering (F), Iridex (R), Meridian Medical (F, C), Novartis (R, C), Roche (R, C), Vitreq (F). F. Ziemssen: Alimera Sciences (C, S), Allergan/AbbVie (C, S), Bayer (C, S, F), Boehringer-Ingelheim (C), Novartis (C, S, F), Novo Nordisk (C), MSD (C), Oxurion (C), Roche/Genentech (C, S, F), BDI (S), CME Health (S), ODOS (S), BMBF (F), Clearside (F), DFG (F), Kodiak (F), Iveric (F), Ophtea (F), Regeneron (F). B. Hägele, C. Junkes, M. Porstner, J. Vögeler, B. Gmeiner: full time employment at Novartis Pharma GmbH. B. Gmeiner: shareholder of Novartis Pharma AG. (Disclosure codes: F, financial support of research projects; R, recipient of lecture fees, travel reimbursements; C, consultant; P, Patent.)

Für diesen Beitrag wurden von den Autor/-innen keine Studien an Menschen oder Tieren durchgeführt. Für die aufgeführten Studien gelten die jeweils dort angegebenen ethischen Richtlinien.

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Faatz, H., Feltgen, N., Gutfleisch, M. et al. Prospektive nichtinterventionelle BLUE SKY-Studie zur Beurteilung der Wirksamkeit von Brolucizumab bei unbehandelten und vorbehandelten Patienten mit neovaskulärer AMD. Ophthalmologie (2022). https://doi.org/10.1007/s00347-022-01731-2

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  • DOI: https://doi.org/10.1007/s00347-022-01731-2

Schlüsselwörter

  • Anti-VEGF-Therapie
  • Brolucizumab
  • Noninterventionelle Studie
  • SS-OCTA
  • Sicherheit

Keywords

  • Anti-VEGF treatment
  • Brolucizumab
  • Noninterventional study
  • SS-OCTA
  • Safety