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

Running, not enrolling · Phase 4

Conditions studied: Neovascular Age-related Macular Degeneration (nAMD)

In brief

This study is a Phase IIIb/IV, multicenter, randomized, two-arm, open-label 100-week study to investigate the efficacy, safety, and durability of intravitreal 6-mg faricimab administered at up to 24-week intervals in patients with neovascular age-related macular degeneration (nAMD) that are treatment-naïve in the study eye.

Key facts

Study ID

NCT06795048

Run by

Hoffmann-La Roche

People needed

274

Starts

2025-03-14

Expected to finish

2027-09-20

Last updated by the study team

2026-07-31

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Florida Retina Institute — Orlando, Florida, United States
• Ctr for Retina & Macular Dis — Winter Haven, Florida, United States
• Retinal Vitreal Consultants — Chicago, Illinois, United States
• University Retina and Macula Associates, PC — Lemont, Illinois, United States
• New England Retina Consultants — Springfield, Massachusetts, United States
• Sierra Eye Associates — Sparks, Nevada, United States
• Retina Associates of New Jersey — Teaneck, New Jersey, United States
• Vision Research Center at Eye Associates of New Mexico — Albuquerque, New Mexico, United States
• Charles Retina Institute — Germantown, Tennessee, United States
• Retina Consultants of Texas — Schertz, Texas, United States
• Strathfield Retina Clinic — Strathfield, New South Wales, Australia
• Sydney Eye Hospital — Sydney, New South Wales, Australia
• Adelaide Eye and Retina Centre — Adelaide, South Australia, Australia
• Centre For Eye Research Australia — East Melbourne, Victoria, Australia
• Retina Specialists Victoria — Rowville, Victoria, Australia
• The Lions Eye Institute — Nedlands, Western Australia, Australia
• St. Joseph's Health Care — London, Ontario, Canada
• Retina Institute of Ottawa — Ottawa, Ontario, Canada
• Toronto Retina Institute — Toronto, Ontario, Canada
• Toronto Western Hospital — Toronto, Ontario, Canada
• Hopital du Saint Sacrement — Québec, Quebec, Canada
• Peking University People's Hospital — Beijing, China
• West China Hospital of Sichuan University — Chengdu, China
• Sichuan Provincial People's Hospital — Chengdu, China
• Orange County Retina Medical Group — Santa Ana, California, United States

Full record on ClinicalTrials.gov

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