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

NCT06795048

Active Not RecruitingPhase 4

Sponsor: Hoffmann-La Roche

Conditions: Neovascular Age-related Macular Degeneration (nAMD)

Interventions: Faricimab

Countries: United States, Australia, Canada, China, France, Germany, Italy, Singapore

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.

Eligibility overview

Sex: ALL

Age: 50 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (67)

Santa Ana, California, United States
Orlando, Florida, United States
Winter Haven, Florida, United States
Chicago, Illinois, United States
Lemont, Illinois, United States
Springfield, Massachusetts, United States
Sparks, Nevada, United States
Teaneck, New Jersey, United States
Albuquerque, New Mexico, United States
Germantown, Tennessee, United States
Schertz, Texas, United States
Strathfield, New South Wales, Australia
Sydney, New South Wales, Australia
Adelaide, South Australia, Australia
East Melbourne, Victoria, Australia
Rowville, Victoria, Australia
Nedlands, Western Australia, Australia
London, Ontario, Canada
Ottawa, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Québec, Quebec, Canada
Beijing, China
Chengdu, China
Chengdu, China
Guangzhou, China
Shanghai, China
Wuhan, China
Bordeaux, France
Lyon, France
+ 37 more on CT.gov