Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hoffmann-La Roche
Age
50–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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
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 be if
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
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
Clareo Health | A Study to Determine the Efficacy, Safety, and Durability of Faricimab in Participants With Neovascular Age-Related Macular Degeneration
