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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Active Comparator | an intravitreal (inside the eye) injection of faricimab 6 mg at the first study visit (loading dose). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| CST Value | To assess central macular subfield thickness (CST) change from baseline to week 52. | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| BCVA | To assess change in BCVA (measured by ETDRS Letter Score) from baseline to week 52. | 52 weeks |
| CNV Thickness | To assess change in CNV thickness from baseline to week 52. |
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Inclusion 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:
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:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kelye Conrad, Clinical Research Manager | Contact | 1+513-569-3688 | kconrad@cvphealth.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnati Eye Institute | Recruiting | Cincinnati | Ohio | 45242 | United States |
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|
| 52 weeks |
| CVP Physicians Dayton | Recruiting | Dayton | Ohio | 45459 | United States |
|
| ID | Term |
|---|---|
| C000723200 | faricimab |
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