[Faricimab in previously treated neovascular age-related macular degeneration : Study design of the prospective noninterventional study PASSENGER].

BACKGROUND

Faricimab was approved in the European Union in 9/2022 as the first bispecific antibody for the treatment of neovascular age-related macular degeneration (nAMD), visual impairment due to diabetic macular oedema (DME) or retinal vein occlusion. To date, the efficacy profile of faricimab has been investigated under pivotal clinical phase 3 study conditions in treatment-naïve nAMD patients. The prospective noninterventional study (NIS) PASSENGER is a multicentre study that aims at contributing to a better understanding of the effectiveness, safety and impact of faricimab on quality of life in previously treated patients with nAMD under real-world conditions in Germany.

METHODS

The planned observation period per patient is 24 months. Patients (n = 620) aged ≥ 50 years with nAMD who switched to faricimab no longer than 12 weeks prior to enrolment in the study, were previously treated with a vascular endothelial growth factor (VEGF) inhibitor for a maximum of 36 months, and had a best corrected visual acuity (BCVA) of 30-80 letters on the Early Treatment Diabetic Retinopathy Study (ETDRS) scale at the start of therapy with faricimab are eligible to participate. The primary outcome measure is the change in BCVA from baseline after 52 weeks. In addition, central subfield thickness, intraretinal, subretinal and subpigment epithelial fluid over time as well as patient-reported outcomes, adherence and adverse events are recorded.

RESULT: The first patient was enrolled in June 2023. According to the current schedule, recruitment (24 months) will be completed by June 2025 and the last patient visit is anticipated in Q2/2027.

CONCLUSION

Data from the PASSENGER study are intended to contribute to a better understanding of therapy management in daily practice in Germany.