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NCT06795048
A Study to Determine the Efficacy, Safety, and Durability of Faricimab in Participants With Neovascular Age-Related Macular Degeneration
Conditions: Neovascular Age-related Macular Degeneration (nAMD)
Sex: All
Ages: 50 Years – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 274
Sponsor: Hoffmann-La Roche
Location: Orange County Retina Medical Group Santa Ana California
Summary
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 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
Source: ClinicalTrials.gov (NCT06795048). StuddyBuddy aggregates publicly available trial information.