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

Official title

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

Overview

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

• Drug Faricimab 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.

Primary outcome measures

• CST Value [Time frame: 52 weeks]

Secondary outcome measures (2)

• BCVA [Time frame: 52 weeks]
• CNV Thickness [Time frame: 52 weeks]

Eligibility criteria

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)

Exclusion criteria

• 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

o Note: Ongoing prophylactic antibiotic therapy is allowed

• 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

Ocular exclusion criteria for study eye:

Patients will be excluded if the study eye meets any of the following criteria:

• 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

Ocular exclusion criteria for non-study eye:

Patients will be excluded if the non-study eye meets any of the following criteria:

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 2 centers

• Cincinnati Eye Institute — Cincinnati
• CVP Physicians Dayton — Dayton

Identifiers

NCT: NCT07695298 · ML46383

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗