New eye drug faricimab aims to control wet AMD with fewer shots
NCT ID NCT07367282
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 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: 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Macular degeneration are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The places running it
5 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
RECRUITINGSeoul, South Korea
-
Kyung Hee University Medical Center
NOT_YET_RECRUITINGSeoul, South Korea
-
Samsung Medical Center
RECRUITINGSeoul, South Korea
-
Seoul National University Bundang Hospital
RECRUITINGSeongnam, South Korea
-
Seoul St. Mary's Hospital
NOT_YET_RECRUITINGSeoul, South Korea
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can fewer eye injections dry the retina in wet AMD?
- The 20-Minute squeeze: how eye injections push pressure up
- Could years of eye injections weigh down the upper eyelid?
- One shot in the eye: gene therapy aims to replace repeated injections for wet AMD
- A clogged artery behind dry macular degeneration? a new scan puts it to the test
- Can a One-Time gene injection ease the burden of wet AMD?