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

Korábbi kezelés

• 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:

Más betegség

• Current vitreous hemorrhage on Day 1
• 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

Egyéb

• 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
• 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:

• 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