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  • Guymer, RobynUniversity of Melbourne (författare)

Rationale and Design of VOYAGER : Long-term Outcomes of Faricimab and Port Delivery System with Ranibizumab for Neovascular Age-Related Macular Degeneration and Diabetic Macular Edema in Clinical Practice

  • Artikel/kapitelEngelska2024

Förlag, utgivningsår, omfång ...

  • Elsevier,2024

Nummerbeteckningar

  • LIBRIS-ID:oai:portal.research.lu.se:publications/dac03fb1-a2d6-4e91-9e16-3df6f79cca46
  • oai:portal.research.lu.se:publications/dac03fb1-a2d6-4e91-9e16-3df6f79cca46URI
  • https://doi.org/10.1016/j.xops.2023.100442DOI

Kompletterande språkuppgifter

  • Språk:engelska
  • Sammanfattning på:engelska

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Klassifikation

  • Ämneskategori:ref swepub-contenttype
  • Ämneskategori:art swepub-publicationtype

Anmärkningar

  • Purpose: To describe the rationale and design of the VOYAGER (NCT05476926) study, which aims to investigate the safety and effectiveness of faricimab and the Port Delivery System with ranibizumab (PDS) for neovascular age-related macular degeneration (nAMD) or diabetic macular edema (DME) in clinical practice. VOYAGER also aims to understand drivers of clinical practice treatment outcomes by gaining novel insight into the intersection of treatment regimens, decisions, anatomic outcomes, and vision. Design: Primary data collection, noninterventional, prospective, multinational, multicenter clinical practice study. Participants: At least 5000 patients initiating/continuing faricimab or PDS for nAMD/DME (500 sites, 31 countries). Methods: Management will be per usual care, with no mandated scheduled visits/imaging protocol requirements. Using robust methodologies, relevant clinical and ophthalmic data, including visual acuity (VA), and data on treatment clinical setting/regimens/philosophies, presence of anatomic features, and safety events will be collected. Routinely collected fundus images will be uploaded to the proprietary Imaging Platform for analysis. An innovative investigator interface will graphically display the patient treatment journey with the aim of optimizing treatment decisions. Main Outcome Measures: Primary end point: VA change from baseline at 12 months per study cohort (faricimab in nAMD and in DME, PDS in nAMD). Secondary end points: VA change over time and per treatment regimens (fixed, treat-and-extend, pro re nata, and other) and number. Exploratory end points: VA change in relation to presence/location of anatomic features that impact vision (fluid, central subfield thickness, fibrosis, atrophy, subretinal hyperreflective material, diabetic retinopathy severity, and disorganization of retinal inner layers) and per treatment regimen/philosophies. The impact of regional and practice differences on outcomes will be assessed as will safety. Results: Recruitment commenced in November 2022 and will continue until late 2027, allowing for up to 5 years follow-up. Exploratory interim analyses are planned annually. Conclusions: VOYAGER is an innovative study of retinal diseases that will assess the effectiveness and safety of faricimab and PDS in nAMD and DME and identify clinician- and disease-related factors driving treatment outcomes in clinical practices globally to help optimize vision outcomes. Financial Disclosure(s): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Ämnesord och genrebeteckningar

Biuppslag (personer, institutioner, konferenser, titlar ...)

  • Bailey, ClareUniversity Hospitals Bristol and Weston NHS Trust,University Hospitals Bristol and Weston NHS Trust, Bristol (författare)
  • Chaikitmongkol, VorapornChiang Mai University, (författare)
  • Chakravarthy, UshaQueen's University Belfast (författare)
  • Chaudhary, VarunMcMaster University (författare)
  • Finger, Robert P.Heidelberg University (författare)
  • Gallego-Pinazo, Roberto (författare)
  • Chuan, Adrian Koh Hock (författare)
  • Ishida, SusumuHokkaido University (författare)
  • Lövestam-Adrian, MonicaClinical and epidemiological studies in medical retinal disorders,Ophthalmology, Lund,Kliniska och epidemiologiska studier av medicinska retinasjukdomar,Oftalmologi, Lund,Skåne University Hospital(Swepub:lu)10505216-5a10-48b9-8ba6-3c350a1a8f29 (författare)
  • Parravano, MariacristinaFondazione G.B. Bietti (författare)
  • Luna Pinto, Jose D. (författare)
  • Schmitz-Valckenberg, SteffenUniversity of Utah Health Care,University Hospital Bonn,Universitätsklinikum Bonn (författare)
  • Sheth, VeeralUniversity of Illinois at Chicago (författare)
  • Souied, Eric H. (författare)
  • Chi, Gloria C.Genentech, Inc,Genentech, Inc (författare)
  • Gilberg, FrankF. Hoffmann-La Roche AG (författare)
  • Glittenberg, CarlF. Hoffmann-La Roche AG (författare)
  • Scheidl, StefanF. Hoffmann-La Roche AG (författare)
  • Bengus, MonicaF. Hoffmann-La Roche AG (författare)
  • University of MelbourneUniversity Hospitals Bristol and Weston NHS Trust (creator_code:org_t)

Sammanhörande titlar

  • Ingår i:Ophthalmology Science: Elsevier4:32666-9145

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