Skip to main content
SpringerLink
Log in

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

  • Originalien
  • Published:
Die Ophthalmologie Aims and scope Submit manuscript

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.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Abb. 1
Abb. 2

Literatur

  1. Professional Association of German Ophthalmologists (Berufsverband der Augenärzte Deutschlands e. V., B., German Society of Ophthalmology (Deutsche Ophthalmologische Gesellschaft e. V., D. German Retina Society e. V. (Retinologische Gesellschaft e. V., R. Statement of the Professional Association of German Ophthalmologists (BVA), the German Society of Ophthalmology (DOG) and the German Retina Society (RG) on central serous chorioretinopathy. Ophthalmol. 116, 10–20 (2019).

  2. Solomon SD, Lindsley K, Vedula SS, Krzystolik MG, Hawkins BS (2014) Anti-vascular endothelial growth factor for neovascular age-related macular degeneration. Cochrane Database Syst Rev. https://doi.org/10.1002/14651858.CD005139.pub3

    Article  PubMed  Google Scholar 

  3. Dugel PU et al (2020) HAWK and HARRIER: phase 3, multicenter, randomized, double-masked trials of brolucizumab for neovascular age-related macular degeneration. Ophthalmology 127:72–84

    Article  PubMed  Google Scholar 

  4. Dugel PU et al (2021) HAWK and HARRIER: ninety-six-week outcomes from the phase 3 trials of brolucizumab for neovascular age-related macular degeneration. Ophthalmology 128:89–99

    Article  PubMed  Google Scholar 

  5. Monés J et al (2021) Risk of inflammation, retinal vasculitis, and retinal occlusion-related events with brolucizumab: post hoc review of HAWK and HARRIER. Ophthalmology 128:1050–1059

    Article  PubMed  Google Scholar 

  6. Holz FG, Heinz C, Wolf A, Hoerauf H, Pleyer U (2021) Intraocular inflammation with brolucizumab use : patient management-diagnosis-therapy. Ophthalmologe 118:248–256

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  7. Brinkmann CK et al (2019) Initiale Diagnostik und Indikationsstellung zur Anti-Vascular-Endothelial Growth-Factor-Therapie bei Netzhauterkrankungen. Ophthalmol 116:753–765

    Article  Google Scholar 

  8. Liakopoulos S et al (2020) ORCA study: real-world versus reading centre assessment of disease activity of neovascular age-related macular degeneration (nAMD). Br J Ophthalmol 104:1573–1578

    PubMed  Google Scholar 

  9. Guymer RH et al (2019) Tolerating subretinal fluid in neovascular age-related macular degeneration treated with ranibizumab using a treat-and-extend regimen: FLUID study 24-month results. Ophthalmology 126:723–734

    Article  PubMed  Google Scholar 

  10. Reiter GS et al (2021) Analysis of fluid volume and its impact on visual acuity in the fluid study as quantified with deep learning. Retina 41:1318–1328

    CAS  PubMed  Google Scholar 

  11. Holz FG et al (2016) Key drivers of visual acuity gains in neovascular age-related macular degeneration in real life: findings from the AURA study. Br J Ophthalmol 100:1623–1628

    Article  PubMed  Google Scholar 

  12. Finger RP, Wiedemann P, Blumhagen F, Pohl K, Holz FG (2013) Treatment patterns, visual acuity and quality-of-life outcomes of the WAVE study—A noninterventional study of ranibizumab treatment for neovascular age-related macular degeneration in Germany. Acta Ophthalmol 91:540–546

    Article  CAS  PubMed  Google Scholar 

  13. Ehlken C et al (2018) Treatment of neovascular age-related MACULAR degeneration patients with vascular endothelial growth factor inhibitors in everyday practice: identification of health care constraints in Germany—the PONS study. Retina 38:1134–1144

    Article  CAS  PubMed  Google Scholar 

  14. Framme C et al (2018) Aflibercept for patients with neovascular age-related macular degeneration in routine clinical practice in Germany: twelve-month outcomes of PERSEUS. Ophthalmol Retin 2:539–549

    Article  Google Scholar 

  15. Bulirsch LM et al (2021) Short-term real-world outcomes following intravitreal brolucizumab for neovascular AMD: SHIFT study. Br J Ophthalmol. https://doi.org/10.1136/bjophthalmol-2020-318672

    Article  PubMed  Google Scholar 

  16. Book M et al (2021) Real-life experiences with brolucizumab in recalcitrant neovascular age-related macular degeneration. Ophthalmologe. https://doi.org/10.1007/s00347-021-01474-6

    Article  PubMed  Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Augenzentrum am St. Franziskus Hospital, Hohenzollernring 74, 48145, Münster, Deutschland

    H. Faatz, M. Gutfleisch, B. Heimes-Bussmann, A. Lommatzsch, P. Mussinghoff, G. Spital & D. Pauleikhoff

  2. Universitätsaugenklinik Göttingen, Göttingen, Deutschland

    N. Feltgen

  3. Universitätsaugenklinik Köln, Köln, Deutschland

    T. U. Krohne & S. Liakopoulos

  4. Universitätsaugenklinik Frankfurt, Frankfurt, Deutschland

    S. Liakopoulos

  5. Universitätsaugenklinik Bonn, Bonn, Deutschland

    R. Liegl & S. Schmitz-Valckenberg

  6. Universitätsaugenklinik Gießen, Gießen, Deutschland

    M. Rehak

  7. John A. Moran Eye Center, University of Utah, Salt Lake City, USA

    S. Schmitz-Valckenberg

  8. Augenklinik Sulzbach, Sulzbach, Deutschland

    B. Stanzel

  9. Universitätsaugenklinik Leipzig, Leipzig, Deutschland

    F. Ziemssen

  10. Novartis Pharma GmbH, Nürnberg, Deutschland

    B. Hägele, C. Junkes, M. Porstner, J. Vögeler & B. Gmeiner

Authors
  1. H. Faatz
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. N. Feltgen
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. M. Gutfleisch
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. B. Heimes-Bussmann
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. T. U. Krohne
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. S. Liakopoulos
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. R. Liegl
    View author publications

    You can also search for this author in PubMed Google Scholar

  8. A. Lommatzsch
    View author publications

    You can also search for this author in PubMed Google Scholar

  9. P. Mussinghoff
    View author publications

    You can also search for this author in PubMed Google Scholar

  10. M. Rehak
    View author publications

    You can also search for this author in PubMed Google Scholar

  11. S. Schmitz-Valckenberg
    View author publications

    You can also search for this author in PubMed Google Scholar

  12. G. Spital
    View author publications

    You can also search for this author in PubMed Google Scholar

  13. B. Stanzel
    View author publications

    You can also search for this author in PubMed Google Scholar

  14. F. Ziemssen
    View author publications

    You can also search for this author in PubMed Google Scholar

  15. B. Hägele
    View author publications

    You can also search for this author in PubMed Google Scholar

  16. C. Junkes
    View author publications

    You can also search for this author in PubMed Google Scholar

  17. M. Porstner
    View author publications

    You can also search for this author in PubMed Google Scholar

  18. J. Vögeler
    View author publications

    You can also search for this author in PubMed Google Scholar

  19. B. Gmeiner
    View author publications

    You can also search for this author in PubMed Google Scholar

  20. D. Pauleikhoff
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to D. Pauleikhoff.

Ethics declarations

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.

Additional information

figure qr

QR-Code scannen & Beitrag online lesen

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

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 120, 294–300 (2023). https://doi.org/10.1007/s00347-022-01731-2

Download citation

  • Received:

  • Revised:

  • Accepted:

  • Published:

  • Issue Date:

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

Schlüsselwörter

Keywords

Search

Navigation