A Study to Determine the Efficacy, Safety, and Durability of Faricimab in Participants With Neovascular Age-Related Macular Degeneration
- Eye Disorder
- Neovascular Age-related Macular Degeneration
Not yet recruiting
NCT06795048 2024-517545-13-00 MR45638
Study 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.
A Phase IIIb/IV, Multicenter, Randomized, Open-Label, Two-Arm Study to Investigate the Efficacy, Safety, and Durability of Faricimab Administered up to Every 24 Weeks in Patients With Neovascular Age-Related Macular Degeneration
Eligibility 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
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
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