Macular DegenerationPhase 4nAMDNCT07367282
Evaluate the Efficacy of Faricimab in Patients With Neovascular Age-related Macular Degeneration
A Phase 4 study testing Faricimab Injection [Vabysmo] in people with Macular Degeneration, run by Junyeop Lee at 5 sites in South Korea.
Trial summary
If the subject who has nAMD voluntarily agrees to participate in this clinical study by signing the informed consent form, screening assessments will be conducted within 4 weeks prior to the first dose of the investigational drug. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Macular Degeneration
- 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
- 64 participants
- Where
- 5 sitesSouth Korea
- Study dates
- 29 Jun 2026to 31 Dec 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals who voluntarily agree to participate in this clinical study and provide written informed consent
- Male or female adults aged 50 years or older at the time of consent
- Individuals who, in the opinion of the investigator, are capable of complying with the requirements of the study protocol
- Ocular Conditions
- Individuals with a BCVA equivalent of ETDRS 24 letters or more, as measured at the time of screening.
- 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.
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- Treatment naïve patients
- For PCV patients, presence of active polypoidal lesions in the macula as shown by Indocyanine green angiography (ICGA) AND presence of serosanguinous maculopathy
- For PCV patients, greatest liner dimension (GLD) of the total lesion area <5400 μm as delineated by ICGA.
Who cannot join
- Any major illness or major surgical procedure within 1 month before screening.
- 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.
- 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.
- 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.
- Immune system abnormalities that may affect inflammatory biomarkers in aqueous humor (AH).
- 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.
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- Systemic treatment for suspected or active systemic infection at screening. Ongoing prophylactic antibiotic use may be acceptable at the investigator's discretion.
- 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.
- Receipt of systemic immunomodulatory therapy or immunosuppressive agents within 6 months prior to screening or within 5 drug half-lives (whichever is longer).
- 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.
- Pregnant or breastfeeding women.
- 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
- 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).
- 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.
- 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.
- Presence of retinal pigment epithelial (RPE) tear involving the macula in the study eye.
- 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.
- Presence of vitreous hemorrhage in the study eye at screening or baseline visits.
- 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).
- History or clinical evidence of proliferative diabetic retinopathy, diabetic macular edema, or other retinal vascular diseases in the study eye, other than AMD.
- 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.
- 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.
- 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.
- Presence of glaucoma in the study eye with uncontrolled intraocular pressure ≥25 mmHg despite pharmacological therapy.
- Presence of active ocular inflammation or suspected or active ocular or periocular infection in either eye at screening.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
South Korea5 sites, 5 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam
Se Joon Woo, PhD
- Recruiting
Asan Medical Center
Seoul
Junyeop LEE, PhD, 82-2-3010-3975, j.lee.amc@gmail.com
- Not yet recruiting
Kyung Hee University Medical Center
Seoul
Kiyoung Kim
- Recruiting
Samsung Medical Center
Seoul
Je Moon Yoon
- Not yet recruiting
Seoul St. Mary's Hospital
Seoul
Young-gun Park
About this study
Official title: A Phase IV, Prospective, Open-label, Single-arm Clinical Trial to Evaluate the Efficacy of Faricimab and Biomarker Assessment in Patients With Neovascular Age-related Macular Degeneration
If the subject who has nAMD voluntarily agrees to participate in this clinical study by signing the informed consent form, screening assessments will be conducted within 4 weeks prior to the first dose of the investigational drug. During the screening visit, the eligibility of the subject will be assessed and one study eye will be selected. If both eyes are eligible, the eye with the worst best-corrected visual acuity (BCVA) at screening will be chosen. However, if the investigator determines that the other eye requires more urgent treatment for clinical reasons, that eye may be selected as the study eye.
After screening assessments and evaluation based on inclusion/exclusion criteria, eligible subjects will be enrolled. Vabysmo® 6 mg (0.05 mL) will be administered via intravitreal injection every 4 weeks (monthly) for a total of 4 doses during the initial loading period. After the loading dose, patients will undergo disease activity assessment based on imaging and visual acuity (VA) outcomes followed by the IP administration at Week 20. The treatment interval will be determined based on disease activity assessed at Week 20, depending on the results, the subsequent administration may be scheduled at Week 28 or Week 32, at the investigator's discretion. Thereafter, the dosing interval may be further adjusted in 4-week increments, either extended or shortened, according to imaging and visual outcomes.
Read more
Throughout the clinical study, patients will need to visit the study site at least 10 times, including the screening visit. The number of intravitreal injections administered will be 4 doses during the initial loading period and up to 5 doses during the treat-and-extend (T\&E) period (Weeks 20, 28, 36, 44, 52). Thus, the total number of injections during the study will range from a minimum of 7 to a maximum of 9 injections.
If the non-study eye also has nAMD, treatment with a locally approved therapy may be administered outside the scope of this study.
- Conditions
- Macular Degeneration
- Being tested
- Faricimab Injection [Vabysmo]
- Keywords
- Neovascular Age-related Macular Degeneration
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Faricimab Injection [Vabysmo]Drug
Faricimab Injection 6mg 0.05 cc
| Study group | Role | What they receive |
|---|---|---|
| Faricimab | Experimental | Faricimab injection Receives: Drug: Faricimab Injection [Vabysmo] |
What is being measured
The primary outcome is the main question the study is designed to answer.
ANG-2 level in aqueous humour (AH)
Measurement of ANG-2 levels in aqueous humor (AH) and the change from baseline to week 20
Measured: at Week 20 from baseline
Secondary outcomes (14)
Endothelial ANG-2 level in aqueous humour (AH)
Changes of endothelial ANG-2 level in aqueous humour (AH) at visits compared from baseline at Weeks 4, 12, 20 and 52
Measured: At weeks 4, 12, 20 and 52 from baseline
BCVA measurement
Best Corrected Visual Acuity (BCVA) change from baseline at Weeks 20 and 52
Measured: At weeks 20 and 52 from baseline
Subfoveal choroidal thickness
Change in subfoveal choroidal thickness at Weeks 20 and 52 compared to baseline (limited to PCV patients)
Measured: At weeks 20 and 52 from baseline
Central subfield thickness (CST)
Central subfield thickness (CST) change from baseline at Weeks 20 and 52
Measured: At weeks 20 and 52 from baseline
Intraretinal microaneurysms and vessel density of the deep capillary plexus
Change in the number of intraretinal microaneurysms and vessel density of the deep capillary plexus at Weeks 20 and 52 compared to baseline
Measured: At weeks 20 and 52 from baseline
Area of peripheral non-perfusion in the retina
Change in the area of peripheral non-perfusion in the retina at Weeks 20 and 52 compared to baseline
Measured: At weeks 20 and 52 from baseline
High improvement in vascular stabilization
Proportion of patients who achieved high improvement in vascular stabilization at Week 20 (defined as 2 or more score in Macular Neovascularization Stabilisation Scoring System Score range 0-4, higher scores mean a better outcome)
Measured: from baseline at Weeks 20
Complete polyp regression
Proportion of subjects who experienced complete polyp regression at least once by Weeks 20 and 52 compared to baseline (limited to PCV patients)
Measured: At weeks 20 and 52 from baseline
Polyp inactivation
Proportion of subjects who experienced polyp inactivation at least once by Weeks 20 and 52 compared to baseline (limited to PCV patients)
Measured: At weeks 20 and 52 from baseline
Resolution of central Intraretinal fluid/Subretinal fluid(IRF/SRF)
Proportion of subjects with resolution of central IRF/SRF at Weeks 20 and 52 compared to baseline
Measured: At weeks 20 and 52 from baseline
Vascular remodeling
Proportion of subjects who experiences vascular remodeling with changes in choroidal angiographic features at Weeks 20 and 52 compared to baseline
Measured: At weeks 20 and 52 from baseline
Number of injections per patient
Mean number of injections per patient
Measured: From baseline to Week 52(EOS)
Treatment interval
Proportion of subjects who achieved a treatment interval of ≥12 or 16 weeks at least once during the Treat \& Extend period
Measured: From baseline to Week 52(EOS)
Maximum treatment interval
Distribution of maximum treatment interval during the Treat \& Extend period
Measured: From baseline to Week 52(EOS)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start29 Jun 2026
- Primary completion30 Apr 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular DegenerationStudies 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
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Junyeop Lee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Junyeop Lee, Asan Medical Center
- Investigators
- Junyeop Lee, PhD, Study director, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07367282
- Sponsor's protocol ID
- AMD_ML46106
- Acronym
- nAMD
- Status last verified
- Jul 2026
- First submitted
- 18 Jan 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV, Prospective, Open-label, Single-arm Clinical Trial to Evaluate the Efficacy of Faricimab and Biomarker Assessment in Patients With Neovascular Age-related Macular Degeneration
- ClinicalTrials.gov ID
- NCT07367282
- Acronym / sponsor ID
- nAMD / AMD_ML46106
- Conditions
- Macular Degeneration
- Keywords
- Neovascular Age-related Macular Degeneration
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Junyeop LeeUniversity, hospital or other
- Study start
- 29 Jun 2026 (actual)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 26 Jan 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.
If the subject who has nAMD voluntarily agrees to participate in this clinical study by signing the informed consent form, screening assessments will be conducted within 4 weeks prior to the first dose of the investigational drug. During the screening visit, the eligibility of the subject will be assessed and one study eye will be selected. If both eyes are eligible, the eye with the worst best-corrected visual acuity (BCVA) at screening will be chosen. However, if the investigator determines that the other eye requires more urgent treatment for clinical reasons, that eye may be selected as the study eye.
After screening assessments and evaluation based on inclusion/exclusion criteria, eligible subjects will be enrolled. Vabysmo® 6 mg (0.05 mL) will be administered via intravitreal injection every 4 weeks (monthly) for a total of 4 doses during the initial loading period. After the loading dose, patients will undergo disease activity assessment based on imaging and visual acuity (VA) outcomes followed by the IP administration at Week 20. The treatment interval will be determined based on disease activity assessed at Week 20, depending on the results, the subsequent administration may be scheduled at Week 28 or Week 32, at the investigator's discretion. Thereafter, the dosing interval may be further adjusted in 4-week increments, either extended or shortened, according to imaging and visual outcomes.
Throughout the clinical study, patients will need to visit the study site at least 10 times, including the screening visit. The number of intravitreal injections administered will be 4 doses during the initial loading period and up to 5 doses during the treat-and-extend (T\&E) period (Weeks 20, 28, 36, 44, 52). Thus, the total number of injections during the study will range from a minimum of 7 to a maximum of 9 injections.
If the non-study eye also has nAMD, treatment with a locally approved therapy may be administered outside the scope of this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Faricimab | Experimental | Drug: Faricimab Injection [Vabysmo]Faricimab injection |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Individuals who voluntarily agree to participate in this clinical study and provide written informed consent
- Male or female adults aged 50 years or older at the time of consent
- Individuals who, in the opinion of the investigator, are capable of complying with the requirements of the study protocol
- Ocular Conditions
- Individuals with a BCVA equivalent of ETDRS 24 letters or more, as measured at the time of screening.
Key exclusion criteria (26 listed)
- Any major illness or major surgical procedure within 1 month before screening.
- 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.
- 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.
- 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.
- Immune system abnormalities that may affect inflammatory biomarkers in aqueous humor (AH).
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]Faricimab Injection 6mg 0.05 cc | Drug | Faricimab |
Primary outcome
ANG-2 level in aqueous humour (AH)
Time frame: at Week 20 from baseline
Measurement of ANG-2 levels in aqueous humor (AH) and the change from baseline to week 20
14 secondary outcomes
Endothelial ANG-2 level in aqueous humour (AH)
Time frame: At weeks 4, 12, 20 and 52 from baseline
BCVA measurement
Time frame: At weeks 20 and 52 from baseline
Subfoveal choroidal thickness
Time frame: At weeks 20 and 52 from baseline
Central subfield thickness (CST)
Time frame: At weeks 20 and 52 from baseline
Intraretinal microaneurysms and vessel density of the deep capillary plexus
Time frame: At weeks 20 and 52 from baseline
Area of peripheral non-perfusion in the retina
Time frame: At weeks 20 and 52 from baseline
High improvement in vascular stabilization
Time frame: from baseline at Weeks 20
Complete polyp regression
Time frame: At weeks 20 and 52 from baseline
Polyp inactivation
Time frame: At weeks 20 and 52 from baseline
Resolution of central Intraretinal fluid/Subretinal fluid(IRF/SRF)
Time frame: At weeks 20 and 52 from baseline
Vascular remodeling
Time frame: At weeks 20 and 52 from baseline
Number of injections per patient
Time frame: From baseline to Week 52(EOS)
Treatment interval
Time frame: From baseline to Week 52(EOS)
Maximum treatment interval
Time frame: From baseline to Week 52(EOS)
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 27 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Junyeop Lee, PhD study director
Asan Medical Center
5 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 Macular Degeneration, run by Junyeop Lee at 5 sites in South Korea.
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 9 inclusion and 26 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 27 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 5 sites in South Korea. 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 Junyeop Lee, PhD (82-2-3010-3975, j.lee.amc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ANG-2 level in aqueous humour (AH) (time frame: at Week 20 from baseline). 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 27 Jul 2026.