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

Abstract

PurposeTo 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 routine clinical practice. VOYAGER also aims to understand drivers of real-word treatment outcomes by gaining novel insight into the intersection of treatment regimens, treatment decisions, anatomic outcomes and vision. DesignPrimary data collection, noninterventional, prospective, multinational, multicenter real-world study. ParticipantsAt least 5000 patients initiating or continuing faricimab or PDS for nAMD or DME across 500 sites in 31 countries. MethodsManagement will be per usual care, with no mandated schedule visits or 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 anatomical 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 MeasuresThe primary endpoint is VA change from baseline at 12 months per study cohort (faricimab in nAMD and in DME, PDS in nAMD). Secondary endpoints include VA change over time and according to treatment regimens (fixed, treat-and-extend, pro re nata, other) and number. Exploratory endpoints include VA change in relation to presence/location of anatomical features that impact vision (fluid, central subfield thickness, fibrosis, atrophy, subretinal hyperreflective material, diabetic retinopathy severity, disorganization of retinal inner layers) and according to treatment regimen/philosophies. The impact of regional and practice differences on outcomes will be assessed as will safety (ocular and nonocular adverse events). ResultsRecruitment commenced in November 2022 and will continue until late 2027 allowing for up to 5-years of follow-up. Exploratory interim analyses are planned annually. ConclusionsVOYAGER is an innovative real-world study of retinal diseases that will assess 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 for patients.