This study will evaluate the safety and effects, good or bad of faricimab (Vabysmo®), a drug that is approved by the U.S. Food and Drug Administration (FDA) for other retinal conditions, but its use is considered investigational when used specifically for choroidal neovascularization (CNV) related to presumed ocular histoplasmosis (POHS)
Age ≥18 years at the time of signing the Informed Consent Form
Ability to comply with study protocol requirements, in the investigator's judgment
Willingness to comply with study visits and procedures for the full duration of the 52-week study period
For women of childbearing potential: agreement to use highly effective contraception methods or practice complete abstinence during the study and for at least 3 months following the last dose of the investigational product, in accordance with local regulatory guidelines
Known hypersensitivity to faricimab or any of its excipients Faricimab
Known hypersensitivity to contrast agents (e.g., fluorescein), dilating eye drops, disinfectants (e.g., iodine), anesthetics, or antimicrobial preparations used during the study
History of other significant systemic disease, non-diabetic metabolic dysfunction, abnormal physical examination findings, or clinical laboratory abnormalities that, in the opinion of the investigator, could pose a risk to the patient, interfere with study participation, or confound interpretation of study results
Active malignancy within 12 months prior to Day 1, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin cancer, or prostate cancer with a Gleason score ≤6 and stable PSA for >12 months
Single group
Faricimab Injection [Vabysmo]
DrugSubjects will receive an intravitreal (inside the eye) injection of faricimab 6 mg at the first study visit (loading dose). Subjects will return for monthly study visits for eye exams and imaging and additional faricimab injections may be given on an as-needed basis if specific vision or imaging criteria are met.
CST Value
To assess central macular subfield thickness (CST) change from baseline to week 52.
BCVA
To assess change in BCVA (measured by ETDRS Letter Score) from baseline to week 52.
CNV Thickness
To assess change in CNV thickness from baseline to week 52.
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Cincinnati Eye Institute, Southwest Ohio
Lead sponsor
Genentech, Inc.
Collaborator
