Faricimab for Eye Disease in Ocular Histoplasmosis
This study is looking at how safe and effective a drug called faricimab (Vabysmo®) is for treating choroidal neovascularization (CNV) in people with presumed ocular histoplasmosis syndrome (POHS). CNV is a condition where new, abnormal blood vessels grow in the eye, which can harm your vision. Faricimab works by targeting a protein called VEGF. While faricimab is approved for other eye conditions, its use for POHS-related CNV is still being studied. You may be able to join if you are 18 or older and can follow the study's requirements for 52 weeks. The main goal is to see how faricimab affects the central subfield thickness (CST) in your eye after 52 weeks. The study is currently unclear about its recruitment status.
- Study design
- This is an interventional study involving 25 participants. It is not specified if it is randomized or blinded.
- What's involved
- You would receive an injection of faricimab into your eye at the first visit. You would then have monthly eye exams and imaging for 52 weeks, with additional injections given as needed.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your central subfield thickness (CST) will be measured at 52 weeks.
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NCT07695298
A Prospective Longitudinal Analysis of Faricimab (Vabysmo 6mg) For Choroidal Neovascularization in Presumed Ocular Histoplasmosis Syndrome
Recruiting
PHASE4Ages 18+InterventionalTreatmentCincinnati Eye Institute, Southwest OhioInvestigator-initiated
~25 participants
Updated 2026-07-10 on ClinicalTrials.gov
What's tested:Faricimab Injection [Vabysmo]
At a glance
Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
CST Value
Measured over 52 weeks
Conditions
Where it's being run
2 sites across 1 statesOhio2
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
Exclusion
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
History of stroke (cerebrovascular accident) or myocardial infarction within 12 months prior to Day 1
Febrile illness within 1 week prior to Day 1
Pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose of faricimab
Uncontrolled hypertension, defined as systolic BP \>180 mmHg and/or diastolic BP \>100 mmHg at rest; a repeat measurement ≥30 minutes later on the same day is permitted if the initial reading is elevated
Renal failure requiring renal transplant, hemodialysis, or peritoneal dialysis within 6 months prior to Day 1, or anticipated need for dialysis during the study
Participation in another investigational trial involving treatment with any drug or device (excluding vitamins/minerals) within 3 months or 5 half-lives (whichever is longer) prior to Day 1, or during the study
Clinically significant substance abuse within 12 months prior to screening, in the investigator's judgment
Use of systemic immunomodulatory treatments (e.g., IL-6 inhibitors) within 6 months or 5 half-lives (whichever is longer) prior to Day 1
Use of systemic corticosteroids within 1 month prior to Day 1
Systemic treatment for suspected or active systemic infection
Any prior or concomitant systemic anti-VEGF treatment within 6 months or 5 half-lives (whichever is longer) prior to Day 1
Use of systemic medications known to be toxic to the lens, retina, or optic nerve (e.g., deferoxamine, chloroquine/hydroxychloroquine, tamoxifen, phenothiazines, or ethambutol) within 6 months or 5 half-lives (whichever is longer) prior to Day 1
Receipt of any treatment resulting in systemic immunosuppression within 6 months or 5 half-lives (whichever is longer) prior to Day 1
Requirement for continuous use of medications or therapies listed as prohibited by the protocol
Prior intravitreal anti-VEGF therapy within 6 months prior to Day 1 Faricimab
Presence of significant ocular pathology other than POHS that may affect visual outcomes or confound study assessments (e.g., retinal vein occlusion, proliferative diabetic retinopathy, central serous chorioretinopathy, or advanced age-related macular degeneration)
Presence of a visually significant cataract or other media opacity expected to affect visual acuity or interfere with fundus imaging or OCT evaluation
Active intraocular inflammation (e.g., iritis, uveitis, vitritis) in the study eye at screening
History of endophthalmitis in the study eye
Intraocular pressure \>25 mmHg in the study eye at screening despite maximum tolerated medical therapy
History of vitrectomy or glaucoma filtration surgery in the study eye
Any planned ocular surgery in the study eye during the course of the study
Presence of any ocular condition that could interfere with study assessments or the safety of the patient, including but not limited to:
Active ocular infection or inflammation
Uncontrolled glaucoma or intraocular pressure ≥ 25 mmHg despite treatment
Advanced diabetic retinopathy requiring immediate treatment
Significant media opacity preventing adequate fundus examination or imaging (e.g., dense cataract, vitreous hemorrhage)
History of vitrectomy or ocular surgery in the past 3 months
Any condition likely to require intraocular injections or ocular surgery during the study period
Any known hypersensitivity or allergy to components of faricimab or agents used in ocular procedures (e.g., fluorescein dye, dilating drops)
Any ocular comorbidity that, in the investigator's opinion, could confound the evaluation of the study eye or impact patient safety
What this trial measures
- CST Value52 weeks
To assess central macular subfield thickness (CST) change from baseline to week 52.