Is NCT07695298 recruiting in Cincinnati, OH?

Yes, NCT07695298 is currently recruiting participants at its Cincinnati, OH location. This presumed ocular histoplasmosis clinical trial is actively enrolling qualified participants.

Is participation in this Cincinnati clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Presumed Ocular Histoplasmosis Clinical Trial in Cincinnati, OH

Q: How do I join the presumed ocular histoplasmosis clinical trial in Cincinnati?

To join this clinical trial in Cincinnati, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

About This Presumed Ocular Histoplasmosis Study in Cincinnati

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)

Sponsor: Cincinnati Eye Institute, Southwest Ohio

Who Can Participate

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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Cincinnati?

Yes, this clinical trial (NCT07695298) has an active research site in Cincinnati, OH that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Presumed Ocular Histoplasmosis Treatment Options in Cincinnati, OH

If you're searching for presumed ocular histoplasmosis treatment options in Cincinnati, OH, this clinical trial (NCT07695298) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Cincinnati research site is actively enrolling participants for this phase 4 clinical trial. You'll receive care from experienced presumed ocular histoplasmosis specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all presumed ocular histoplasmosis clinical trials near you to find additional studies recruiting in your area.

Presumed Ocular Histoplasmosis Clinical Trial in Cincinnati, OH

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