Phase
Condition
Geographic Atrophy
Macular Degeneration
Treatment
Faricimab
Clinical Study ID
Ages > 50 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Overtly healthy as determined by medical evaluation that includes medical historyand 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-relatedmacular degeneration (AMD), confirmed by the investigator based on the presence ofintraretinal fluid (IRF) or subretinal fluid (SRF) affecting the central subfield onoptical 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 addressedat the initial testing distance of 4 meters on Day 1)
Sufficiently clear ocular media and adequate pupillary dilation to allow acquisitionof good quality retinal images to confirm diagnosis
Exclusion
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 eitherBCVA 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 ineither eye on study Day 1
Study Design
Connect with a study center
Strathfield Retina Clinic
Strathfield, New South Wales 2135
AustraliaActive - Recruiting
Retina Institute of Ottawa
Ottawa, Ontario K2B 7E9
CanadaActive - Recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung,
TaiwanActive - Recruiting
Ctr for Retina & Macular Dis
Winter Haven, Florida 33880
United StatesActive - Recruiting
University Retina and Macula Associates, PC
Lemont, Illinois 60439
United StatesActive - Recruiting
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