A Prospective Longitudinal Analysis of Faricimab (Vabysmo 6mg) For Choroidal Neovascularization in Presumed Ocular Histoplasmosis Syndrome [PLANE Study]
Cincinnati Eye Institute, Southwest Ohio
Summary
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 * For men with partners of childbearing potential…
Interventions
- DrugFaricimab Injection [Vabysmo]
Subjects 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.
Locations (2)
- Cincinnati Eye InstituteCincinnati, Ohio
- CVP Physicians DaytonDayton, Ohio