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New eye drug faricimab aims to control wet AMD with fewer shots

NCT ID NCT07367282

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 28, 2026 · Updated 4 times

Summary

This phase 4 trial will test the drug faricimab (Vabysmo) in 64 people with wet age-related macular degeneration (AMD). Participants will receive eye injections every 4 weeks for 4 doses, then a treat-and-extend schedule based on disease activity. The study also measures biomarkers in eye fluid to understand treatment response.

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) injection
What this could lead to
If successful, this could confirm faricimab as an effective treatment for wet AMD, potentially improving vision and reducing injection frequency.
What could go wrong
This is a small, single-arm, open-label trial with no placebo group, so results may be less reliable. Risks include eye infection, inflammation, and increased eye pressure from injections.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 64 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

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

50 years and older

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Individuals who voluntarily agree to participate in this clinical study and provide written informed consent 2. Male or female adults aged 50 years or older at the time of consent 3. Individuals who, in the opinion of the investigator, are capable of complying with the requirements of the study protocol Ocular Conditions 1. Individuals with a BCVA equivalent of ETDRS 24 letters or more, as measured at the time of screening. 2. Confirmed diagnosis, by the investigator, of active nAMD based on sufficiently clear ocular media and adequate pupillary dilation allowing acquisition of good quality retinal images for confirmation. 3. Treatment naïve patients 4. For PCV patients, presence of active polypoidal lesions in the macula as shown by Indocyanine green angiography (ICGA) AND presence of serosanguinous maculopathy 5. For PCV patients, greatest liner dimension (GLD) of the total lesion area \<5400 μm as delineated by ICGA. Exclusion Criteria: 1. Any major illness or major surgical procedure within 1 month before screening. 2. Any condition that, in the opinion of the investigator, constitutes a contraindication to the use of faricimab, may affect interpretation of study results, or places the participant at high risk for treatment-related complications, based on medical history, non-diabetic metabolic abnormalities, physical examination findings, or past/current clinical laboratory results. 3. History of active cancer within 12 months prior to screening, except for adequately treated carcinoma in situ of the cervix, non-melanoma skin cancer, or prostate cancer with a Gleason score ≤6 (Grade Group 1) and stable PSA levels for \>12 months. 4. Uncontrolled blood pressure, defined as systolic \>180 mmHg and/or diastolic \>100 mmHg while at rest at baseline. A repeat reading within the screening window may be taken to confirm eligibility. 5. Immune system abnormalities that may affect inflammatory biomarkers in aqueous humor (AH). 6. History of severe allergic or anaphylactic reaction to biologic agents, or known hypersensitivity to any component of the faricimab injection, study-related procedures (including fluorescein and indocyanine green dyes), dilating drops, or any anesthetic/antimicrobial eye drops used during the study. 7. Systemic treatment for suspected or active systemic infection at screening. Ongoing prophylactic antibiotic use may be acceptable at the investigator's discretion. 8. Use of systemic medications known to have toxic effects on the lens, retina, or optic nerve within 6 months prior to screening or within 5 drug half-lives (whichever is longer), or expected future use of such medications. 9. Receipt of systemic immunomodulatory therapy or immunosuppressive agents within 6 months prior to screening or within 5 drug half-lives (whichever is longer). 10. Participation in another clinical study involving an investigational drug, investigational device, or other medical research within 3 months prior to screening, or concurrent participation in such a study. 11. Pregnant or breastfeeding women. 12. Women of childbearing potential planning to become pregnant during the study or within 3 months after the last dose of study treatment, or unwilling to use highly effective contraception methods\* throughout the study period and for 3 months following the last dose. Ocular Conditions 1. Any ocular condition in the study eye that may interfere with the assessment of visual acuity, safety evaluation, or fundus imaging (e.g., advanced cataract). 2. Any current ocular disease in the study eye that, in the opinion of the investigator, increases the procedural risk of intravitreal injection beyond standard expectations or may interfere with injection, efficacy, or safety evaluations. 3. Presence of fibrosis or atrophy involving ≥50% of the total lesion area and/or the fovea in the study eye, as determined by the investigator. 4. Presence of retinal pigment epithelial (RPE) tear involving the macula in the study eye. 5. High myopia with spherical equivalent refractive error \>6 diopters in the study eye. For participants with a history of refractive or cataract surgery, pre-surgical refractive error must not have exceeded -6 diopters. 6. Presence of vitreous hemorrhage in the study eye at screening or baseline visits. 7. History of other macular diseases in the study eye that are unrelated to nAMD but may lead to visual loss or cause intraretinal fluid (IRF) or subretinal fluid (SRF). 8. History or clinical evidence of proliferative diabetic retinopathy, diabetic macular edema, or other retinal vascular diseases in the study eye, other than AMD. 9. Any current ocular condition in the study eye (e.g., cataract) that, in the opinion of the investigator, may require medical or surgical intervention during the study period. 10. History of prior intraocular surgery in the study eye, including but not limited to vitrectomy, glaucoma surgery, corneal transplant, radiation therapy, retinal detachment repair (e.g., scleral buckle or pneumatic retinopexy), trabeculectomy, or other filtration surgeries. 11. History of prior or ongoing treatment for macular neovascularization (MNV) or vitreomacular interface abnormalities in the study eye, including but not limited to intravitreal therapy (faricimab, other anti-VEGF agents, corticosteroids, tissue plasminogen activator, ocriplasmin, C3F8 gas, air), periocular pharmacological interventions, argon laser photocoagulation, verteporfin photodynamic therapy, diode laser, transpupillary thermotherapy, or ocular surgical procedures. 12. Presence of glaucoma in the study eye with uncontrolled intraocular pressure ≥25 mmHg despite pharmacological therapy. 13. Presence of active ocular inflammation or suspected or active ocular or periocular infection in either eye at screening.

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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.

  1. The places running it

    5 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Asan Medical Center

    RECRUITING

    Seoul, South Korea

  • Kyung Hee University Medical Center

    NOT_YET_RECRUITING

    Seoul, South Korea

  • Samsung Medical Center

    RECRUITING

    Seoul, South Korea

  • Seoul National University Bundang Hospital

    RECRUITING

    Seongnam, South Korea

  • Seoul St. Mary's Hospital

    NOT_YET_RECRUITING

    Seoul, South Korea

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