New eye drug could mean fewer shots for PCV patients
NCT ID NCT07461441
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This Phase 3 trial tests faricimab (Vabysmo) in 50 people with a type of age-related macular degeneration called polypoidal choroidal vasculopathy (PCV). The goal is to see if a personalized treat-and-extend schedule can keep the eye healthy while allowing longer breaks between injections—up to 16 weeks or more. Participants receive the drug as an eye injection, and the study tracks vision and retinal thickness over 96 weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- faricimab (Vabysmo)
- What this could lead to
- If successful, this could allow people with PCV to receive eye injections less often (every 16 weeks or more) while maintaining vision.
- What could go wrong
- This is a small Phase 3 trial (50 people) and results may not apply to all patients. Faricimab injections carry risks like eye infection or inflammation.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Mar 2026
An estimate. Start dates often move.
- Expected to finish
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Nov 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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50 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Potential participants are eligible to be included in the study only if all of the following criteria apply: \[Ocular Conditions\] * Presence of active polypoidal lesions in the macula as shown by Indocyanine green angiography (ICGA) AND presence of serosanguinous maculopathy, i.e., exudative or hemorrhagic features involving the macula on color fundus photography (CFP), FA and spectral domain optical coherence tomography (SD-OCT) AND presence of IRF or SRF that affects the central subfield as seen by SD-OCT. * BCVA score must be ≤ 78 and ≥ 24 letters at 4 meters starting distance using early treatment diabetic retinopathy study (ETDRS) visual acuity charts at both Screening and Baseline. * Greatest liner dimension (GLD) of the total lesion area (branching vascular network \[BVN\] + polypoidal lesion) \< 5400 μm (equivalent to 9 macular photocoagulation study \[MPS\] Disc Area) as delineated by ICGA. \[Systemic Conditions\] * Signed Informed Consent Form * Age ≥ 50 years at the time of signing Informed Consent Form * Participants who are able to comply with the study protocol, in the investigator's judgment * For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception (will be defined in details in protocol) Exclusion Criteria: Potential participants are excluded from the study if any of the following criteria apply: \[Ocular Conditions\] in the Study Eye * Previous treatment with any anti-VEGF drugs or faricimab or investigational drugs at any time prior to Baseline. * Previous use of intraocular or periocular steroids within the 6-month period prior to Baseline. * Macular laser photocoagulation (focal/grid) or PDT at any time prior to Baseline and peripheral laser photocoagulation within 3 months prior to Baseline. * Treatment with investigational therapy (device, drug, or traditional medicine with the exception of vitamins and minerals) within 3 months prior to initiation of study treatment on study Day 1 * Concomitant conditions or ocular disorders in the study eye at Screening or Baseline which could, in the opinion of the Investigator, prevent response to study treatment or may confound interpretation of study results, compromise visual acuity or require planned medical or surgical intervention during the first 12-month study period. * Presence of subfoveal geographic atrophy or extensive retinal pigment epithelial atrophy involving the central subfield that, in the opinion of the investigator, may limit visual potential. * Presence of subfoveal fibrosis or scarring involving the central subfield as identified on color fundus photography or OCT. * Presence of subretinal or sub-RPE hemorrhage involving ≥50% of the total lesion area, or any hemorrhage obscuring the fovea. * Any active intraocular or periocular infection or active intraocular inflammation (IOI) in study eye or fellow eye at Screening or Baseline. * Uncontrolled glaucoma in the study eye defined as intraocular pressure (IOP) \> 25 mmHg on medication, or according to Investigator's judgment, at Screening or Baseline. * Any PCV masquerades like macular aneurysms, macular telangiectasia, etc. in study eye. Add these EC fro both eyes Potential participants are excluded from the study if any of the following criteria apply: * History of idiopathic or autoimmune-associated uveitis in either eye * Active ocular inflammation or suspected or active ocular or periocular infection in either eye on study Day 1 \[Systemic Conditions\] * Systemic anti-VEGF therapy any time prior to Baseline. * Any major illness or major surgical procedure within 1 month before screening * Active cancer within the 12 months prior to study Day 1 except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, and prostate cancer with a Gleason score of \< 6 (Grade Group of 1) and a stable prostate-specific antigen for \>12 months * Continuous use of any medications and treatments (which will be indicated in the Prohibited Therapy section in protocol) * Systemic treatment for suspected or active systemic infection on study Day 1 * Uncontrolled blood pressure, defined as systolic blood pressure \> 180 mmHg and/or diastolic blood pressure \> 100 mmHg while the participant is at rest on study Day 1 * History of stroke (cerebral vascular accident) or myocardial infarction within 6 months prior to study Day 1 * History of other disease, metabolic dysfunction, physical examination finding, or historical or current clinical laboratory findings giving reasonable suspicion of a condition that contraindicates the use of the investigational drug or that might affect interpretation of the results of the study or renders the participant at high risk for treatment complications in the opinion of the investigator * History of severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the faricimab injection, study-related procedure preparations (including fluorescein and indocyanine green dyes), dilating drops, or any of the anesthetic and antimicrobial preparations used by a participant during the study * Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 28 days after the final dose of faricimab
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Yeungnam university medical center
RECRUITINGDaegu, Namgu, 42415, South Korea
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