A Prospective Longitudinal Analysis of Faricimab (Vabysmo 6mg) For Choroidal Neovascularization in Presumed Ocular Histoplasmosis Syndrome

NCT07695298 | Recruiting Phase 4 FDA Drug

• 1 other identifier: ML46383
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

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)

Conditions

Presumed Ocular Histoplasmosis

Keywords

POHS

Outcome Measures

Primary Outcomes (1)

• CST Value

  To assess central macular subfield thickness (CST) change from baseline to week 52.

  52 weeks

Secondary Outcomes (2)

• BCVA

  52 weeks

• CNV Thickness

  52 weeks

Study Arms (1)

Treatment

ACTIVE COMPARATOR

an intravitreal (inside the eye) injection of faricimab 6 mg at the first study visit (loading dose).

Drug: Faricimab Injection [Vabysmo]

Interventions

Faricimab Injection [Vabysmo] DRUG

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.

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• o Women of childbearing potential must have a negative urine pregnancy test within 28 days prior to initiation and again at the baseline (Day 1) visit
• 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

Sponsors & Collaborators

• Genentech, Inc.: collaborator
• Cincinnati Eye Institute, Southwest Ohio: lead

Study Sites (2)

Cincinnati Eye Institute

Cincinnati, Ohio, 45242, United States

RECRUITING

CVP Physicians Dayton

Dayton, Ohio, 45459, United States

RECRUITING

MeSH Terms

Interventions

faricimab

Central Study Contacts

Kelye Conrad, Clinical Research Manager

CONTACT

1+513-569-3688; kconrad@cvphealth.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2026
• First Posted: July 10, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: July 10, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)