Presumed Ocular Histoplasmosis
Conditions
Keywords
POHS
Brief 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)
Interventions
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.
Sponsors
Cincinnati Eye Institute, Southwest Ohio
Genentech, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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: agreement to use effective contraception or practice complete abstinence during the study and for at least 3 months following the last dose of the investigational product * Presence of choroidal neovascularization (CNV) secondary to presumed ocular histoplasmosis syndrome (POHS), confirmed by funduscopic examination and supported by OCT imaging * Best-Corrected Visual Acuity (BCVA) between 20/40 and 20/400, inclusive, using the ETDRS letter score system at screening * Central macular subfield thickness (CST) \>300 microns, as measured by spectral-domain OCT * No prior treatment with anti-VEGF agents in the study eye within 6 months prior to screening * No presence of other ocular diseases or conditions in the study eye that could confound visual outcomes, interfere with assessment of treatment efficacy, or pose a safety risk (see
Exclusion criteria
)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CST Value | 52 weeks | To assess central macular subfield thickness (CST) change from baseline to week 52. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| BCVA | 52 weeks | To assess change in BCVA (measured by ETDRS Letter Score) from baseline to week 52. |
| CNV Thickness | 52 weeks | To assess change in CNV thickness from baseline to week 52. |
Countries
United States
Contacts
CONTACTKelye Conrad, Clinical Research Manager
Outcome results
None listed