A Phase IIIb/IV, multicenter, open-label, single-arm study to investigate the efficacy and safety of faricimab (RO6867461) in patients with polypoidal choroidal vasculopathy
Polypoidal choroidal vasculopathy (PCV)
Participants will receive faricimab 6 mg IVT, every 4 weeks (Q4W) from Day 1 up to Week 12. Thereafter, participants with protocol-defined active disease at Weeks 20 and 24 will continue to receive faricimab 6 mg IVT, every 8 weeks (Q8W) up to Week 44 and every 12 weeks (Q12W) up to Week 48, respectively. Participants without protocol-defined active disease at Weeks 20 and 24 will receive faricimab 6 mg IVT, at Week 28 and thereafter every 16 weeks (Q16W) up to Week 44. From Week 44, for participants on a Q8W or Q16W treatment interval, and Week 48 for those on a Q12W treatment interval, all participants will receive a personalized treatment interval (PTI) dosing regimen, ranging from Q8W to every 20 weeks (Q20W), based on disease activity, up to Week 104. At Week 108, participants will attend a follow-up visit following which their participation in the study will be considered as having been completed.
General inclusion criteria: 1. Age ≥50 years at the time of signing the informed consent form Ocular inclusion criteria for study eye: 1. Have sufficiently clear ocular media and adequate pupillary dilatation to allow the acquisition of good-quality retinal images to confirm diagnosis 2. Confirmed diagnosis, by the investigator, of symptomatic macular PCV defined by the following: 2.1. Active macular polypoidal lesions shown by indocyanine green angiography (ICGA) 2.2. Presence of exudative or hemorrhagic features involving the macula as identified by the investigator using multimodal images 3. BCVA scores of 78-24 ETDRS letters, inclusive (20/32 to 20/320 approximate Snellen equivalent), using the ETDRS protocol and assessed at the initial testing distance of 4 m on study Day 1
General exclusion criteria: 1. Treatment with investigational therapy (device, drug, or traditional medicine with the exception of vitamins and minerals) within 3 months prior to initiation of study treatment on study Day 1 2. Any major illness or major surgical procedure within 1 month before screening 3. Active cancer within the 12 months prior to study Day 1 4. Uncontrolled blood pressure, defined as systolic blood pressure >180 mmHg and/or diastolic blood pressure > 100 mmHg while the participant is at rest on study Day 1 5. Participants with a history of stroke (cerebral vascular accident) or myocardial infarction within 6 months prior to study Day 1 6. Participants with history of other disease, metabolic dysfunction, physical examination finding, or historical or current clinical laboratory findings giving reasonable suspicion of a condition that contraindicates the use of the investigational drug or that might affect the interpretation of the results of the study or renders the participant at high risk for treatment complications in the opinion of the investigator 7. Participants with history of severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the faricimab injection, study-related procedure preparations (including fluorescein and indocyanine green dyes), dilating drops, or any of the anesthetic and antimicrobial preparations used by a participant during the study 8. Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 28 days after the final dose of faricimab Ocular exclusion criteria for both eyes: 1. Participants with history of idiopathic or autoimmune-associated uveitis in either eye 2. Participants with active ocular inflammation or suspected or active ocular or periocular infection in either eye on study Day 1 Ocular exclusion criteria for study eye: 1. Any history or presence of macular pathology unrelated to PCV affecting vision or contributing t