About this trial
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)
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Faricimab Injection [Vabysmo]
Treatment groups
Sponsors and collaborators
Cincinnati Eye Institute, Southwest Ohio
Lead sponsor
Genentech, Inc.
Collaborator