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

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 disclosures: Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Keywords: Diabetic macular edema; Faricimab; Neovascular age-related macular degeneration; Port Delivery System with ranibizumab; Real-world study.

Figure 1

Countries with sites participating in the VOYAGER study UAE = United Arab Emirates.

Figure 2

Study design schema ^aStudy end: Study completion or end of termination defined as death, loss to follow-up, withdrawal of consent, participation in an investigational ophthalmology clinical trial, early termination of the study, or discontinuation of the study site, whichever occurs first. ^bData will be analyzed at specified time points (e.g., 3, 6, 12, 24, 36, 48, and 60 months with an appropriate window period of ±30 or ±60 days, etc.), for a maximum of approximately 5 years from study entry until study completion/early termination. eCRF = electronic case report form; EMR = electronic medical record; M = months.

Figure 3

The VOYAGER Ecosystem ^aImages collected for future artificial intelligence (AI) analytic tools and assessments include: color fundus photography, fundus fluorescein angiography, indocyanine green angiography, spectral-domain OCT, spectral-domain OCT angiography, swept-source OCT, and swept-source OCT angiography. eCRF = electronic case report form.