Presumed Ocular HistoplasmosisPhase 4PLANENCT07695298
A Prospective Longitudinal Analysis of Faricimab (Vabysmo 6mg) For Choroidal Neovascularization in Presumed Ocular Histoplasmosis Syndrome
A Phase 4 study testing Faricimab Injection [Vabysmo] in people with Presumed Ocular Histoplasmosis, run by Cincinnati Eye Institute, Southwest Ohio at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Presumed Ocular Histoplasmosis
- What is being tested?
- Faricimab Injection [Vabysmo]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2026to May 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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)
Who cannot join
- 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
Show all 41Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Cincinnati Eye Institute
Cincinnati, Ohio, 45242
Kelye Conrad, Clinical Research Manager, 1+ 513-569-3462, kconrad@cvphealth.com
Miguel Busquets, MD
- Recruiting
CVP Physicians Dayton
Dayton, Ohio, 45459
Erica Joo, 937-759-9366, ejoo@cvphealth.com
Martin Wilkes, MD
About this study
Official title: A Prospective Longitudinal Analysis of Faricimab (Vabysmo 6mg) For Choroidal Neovascularization in Presumed Ocular Histoplasmosis Syndrome [PLANE Study]
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
- Being tested
- Faricimab Injection [Vabysmo]
- Keywords
- POHS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Active comparator | an intravitreal (inside the eye) injection of faricimab 6 mg at the first study visit (loading dose). Receives: Drug: Faricimab Injection [Vabysmo] |
What is being measured
The primary outcome is the main question the study is designed to answer.
CST Value
To assess central macular subfield thickness (CST) change from baseline to week 52.
Measured: 52 weeks
Secondary outcomes (2)
BCVA
To assess change in BCVA (measured by ETDRS Letter Score) from baseline to week 52.
Measured: 52 weeks
CNV Thickness
To assess change in CNV thickness from baseline to week 52.
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study startJul 2026 (estimated)
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Presumed Ocular HistoplasmosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cincinnati Eye Institute, Southwest Ohio
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07695298
- Sponsor's protocol ID
- ML46383
- Acronym
- PLANE
- Status last verified
- Jul 2026
- First submitted
- 6 Jul 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Longitudinal Analysis of Faricimab (Vabysmo 6mg) For Choroidal Neovascularization in Presumed Ocular Histoplasmosis Syndrome [PLANE Study]
- ClinicalTrials.gov ID
- NCT07695298
- Acronym / sponsor ID
- PLANE / ML46383
- Conditions
- Presumed Ocular Histoplasmosis
- Keywords
- POHS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Cincinnati Eye Institute, Southwest OhioUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Jul 2026 (estimated)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 10 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Active comparator | Drug: Faricimab Injection [Vabysmo]an intravitreal (inside the eye) injection of faricimab 6 mg at the first study visit (loading dose). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (41 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Treatment |
Primary outcome
CST Value
Time frame: 52 weeks
To assess central macular subfield thickness (CST) change from baseline to week 52.
2 secondary outcomes
BCVA
Time frame: 52 weeks
CNV Thickness
Time frame: 52 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Faricimab Injection [Vabysmo] in people with Presumed Ocular Histoplasmosis, run by Cincinnati Eye Institute, Southwest Ohio at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 41 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kelye Conrad, Clinical Research Manager (1+513-569-3688, kconrad@cvphealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CST Value (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.