Phase 4: testing Faricimab Injection [Vabysmo] for Presumed Ocular Histoplasmosis
This study will measure 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)
Official registry: https://clinicaltrials.gov/study/NCT07695298 · Cincinnati Eye Institute, Southwest Ohio · enrollment listed as 25
What this phase means
Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Faricimab Injection [Vabysmo]. The registry lists allocation as na. This study will measure the safety and effects, good or bad of faricimab (Vabysmo®), a drug that is approved by the U.S.
They plan to enroll about 25 people at 2 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
A Prospective Longitudinal Analysis of Faricimab (Vabysmo 6mg) For Choroidal Neovascularization in Presumed Ocular Histoplasmosis Syndrome [PLANE Study]
Interventions: Faricimab Injection [Vabysmo]
Primary outcome (registry wording): CST Value
Who it is for (from inclusion criteria)
- Ages 18 Years to any
- 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
Who the registry excludes
- People the protocol lists as excluded — the study team must confirm.
Public study contact (from the registry)
Kelye Conrad, Clinical Research Manager
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
2 listed- Cincinnati Eye Institute — Cincinnati, Ohio (recruiting)
- CVP Physicians Dayton — Dayton, Ohio (recruiting)
FAQ about this NCT record
Is NCT07695298 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07695298?
Phase 4. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07695298?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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