A Study to Determine the Efficacy, Safety, and Durability of Faricimab in Participants With Neovascular Age-Related Macular Degeneration

Launched by HOFFMANN-LA ROCHE · Jan 24, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called faricimab for people with neovascular age-related macular degeneration (nAMD), a condition that affects vision. The goal is to find out how well this medication works, how safe it is, and how long its effects last. Participants in this study will receive injections of faricimab in their eyes every 24 weeks for up to 100 weeks. This study is currently looking for patients who have not received any previous treatment for their nAMD and who meet specific health criteria.

To be eligible for the study, participants should be generally healthy and have signs of active macular neovascularization in their eyes, which means there is fluid affecting their vision. They also need to have a certain level of vision that is not too impaired. Those with certain eye conditions or previous treatments for similar issues won't be able to join the trial. Participants can expect regular check-ups and tests to monitor their vision and the health of their eyes throughout the study. This trial is an important step in finding new ways to help people with this type of vision loss.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Overtly healthy as determined by medical evaluation that includes medical history and physical examination
• • Agreement to adhere to the contraception requirements described in the protocol
• Ocular Inclusion Criteria for Study Eye:
• • Active treatment-naïve macular neovascularization (MNV) secondary to age-related macular degeneration (AMD), confirmed by the investigator based on the presence of intraretinal fluid (IRF) or subretinal fluid (SRF) affecting the central subfield on optical coherence tomography (OCT)
• • BCVA of 83 to 24 letters, inclusive (20/25 to 20/320 approximate Snellen equivalent, using the early treatment diabetic retinopathy study \[ETDRS\] protocol and addressed at the initial testing distance of 4 meters on Day 1)
• • Sufficiently clear ocular media and adequate pupillary dilation to allow acquisition of good quality retinal images to confirm diagnosis
• Exclusion Criteria:
• Ocular Exclusion Criteria for Study Eye:
• • MNV due to causes other than nAMD, such as ocular histoplasmosis, trauma, pathological myopia, angioid streaks, choroidal rupture, or uveitis
• • Retinal pigment epithelial tear involving the macula on Day 1
• • Current vitreous hemorrhage on Day 1
• • Prior periocular pharmacological or IVT treatment (including faricimab, anti-vascular endothelial growth factor \[VEGF\], or complement inhibitor medication) for other retinal diseases
• Ocular Exclusion Criteria for Fellow (Non-Study) Eye:
• • Participants who have a nonfunctioning fellow (non-study) eye, defined as either BCVA of hand motion or worse, or no physical presence of non-study eye (i.e., monocular), at both the screening and study Day 1 visits
• Ocular Exclusion for Both Eyes:
• • History of idiopathic or autoimmune associated uveitis in either eye
• • Active ocular inflammation or suspected or active ocular or periocular infection in either eye on study Day 1