Polypoidal Choroidal Vasculopathy (PCV)Phase 3HANGANGNCT07461441
Efficacy and Durability of a Personalized Treat-and-extend Regimen of Faricimab for Treatment-naive Polypoidal Choroidal Vasculopathy
A Phase 3 study testing Faricimab Injection [Vabysmo] in people with Polypoidal Choroidal Vasculopathy (PCV) and Age Related Macular Degeneration, run by Yeungnam University College of Medicine at 1 site in South Korea.
Trial summary
To evaluate the Efficacy of a personalized treat-and-extend regimen of faricimab for treatment-naive polypoidal choroidal vasculopathy Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Polypoidal Choroidal Vasculopathy (PCV), Age Related 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
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Mar 2026to 30 Nov 2028
- Phase
- Phase 3
- 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
- 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]
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- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Yeungnam university medical center
Daegu, Namgu, 42415
Min Sagong, Professor, 82536203215, ey005@ymc.yu.ac.kr
About this study
To evaluate the Efficacy of a personalized treat-and-extend regimen of faricimab for treatment-naive polypoidal choroidal vasculopathy
- Being tested
- Faricimab Injection [Vabysmo]
- Keywords
- Polypoidal Choroidal Vasculopathy (PCV), Faricimab, Age-related macular degeneration
- Medical subject headings
- Polypoidal Choroidal Vasculopathy, 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
After applying topical anesthetic drops, intravitreal injections were delivered with a 30-gauge needle placed 3.5-4.0 mm posterior to the limbus. Patients were treated with faricimab (6 mg/0.05 ml).
| Study group | Role | What they receive |
|---|---|---|
| Faricimab injection | Experimental | Initial Interval - All patients will enter the treat-and-extend (T\&E) phase with an initial injection interval of 8 weeks following the loading phase.
Disease activity is defined as the presence of any of the following:
* Intraretinal fluid (IRF) or subretinal fluid (SRF) on SD-OCT
* Loss of ≥5 ETDRS letters from the previous visit associated with recurrent fluid
* New or increased retinal/subretinal hemorrhage
Injection Interval Adjustment Algorithm
• Extension: If no signs of disease activity are observed, the injection interval may be extended by 4 weeks, up to a maximum of 24 weeks.
• Shortening: If any disease activity is detected, the injection interval should be shortened by 4 weeks, to a minimum of 4 weeks.
• Maintenance: If no disease activity is present but criteria for extension are not met (e.g., residual stable SRF or investigator discretion), the current interval is maintained. Receives: Drug: Faricimab Injection [Vabysmo] |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients who reached a treatment interval of ≥16 weeks at Week 96 (LV)
Measured: Week 96
Secondary outcomes (9)
Central Subfield Thickness (CST) decrease change from baseline at visit Weeks 4, 8, 12, 16, and 96 (LV)
Average retinal thickness at the central 1 mm diameter
Measured: Week 4, week 8, week 12, week 16, week 96
Proportion of patients who gain ≥10 letters and ≥15 letters in best corrected visual acuity (BCVA) from baseline at Week 96.
Measured: Week 96
Proportion of patients who experienced the polypoidal regression (At weeks 12, 48, 96)
Measured: Week 12, week 48, week 96
Choroidal thickness (at fovea center) at Baseline, at Weeks 12 , 48, 96
Choroidal thickness is measured by optical coherence tomography
Measured: Day 1, Week 12, week 48, week 96
Change in the thickness of the largest polyp and irregular pigment epithelial detachment (PED) as measured by spectral-domain OCT (SD-OCT) at Weeks 12 and 96
Measured: Week 12, week 96
Proportion of patients with complete fluid resolution (no IRF or SRF) at Weeks 12 and 96.
Fluid shown on optical coherence tomography images
Measured: Week 12, week 96
Mean number of injections per patient at week 48 and week 96
Measured: Week 48, week 96
Proportion of patients who maintain their last assigned injection interval at Week 96
Measured: Week 96
Number of participants with treatment-related adverse events
Measured: Through study completion, an average of 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start1 Mar 2026 (estimated)
- Primary completion30 Nov 2028 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polypoidal Choroidal Vasculopathy (PCV)Studies 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yeungnam University College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Min Sagong, Yeungnam University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07461441
- Sponsor's protocol ID
- YUMC 2025-12-022
- Acronym
- HANGANG
- Status last verified
- Mar 2026
- First submitted
- 14 Feb 2026
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Durability of a Personalized Treat-and-extend Regimen of Faricimab for Treatment-naive Polypoidal Choroidal Vasculopathy
- ClinicalTrials.gov ID
- NCT07461441
- Acronym / sponsor ID
- HANGANG / YUMC 2025-12-022
- Keywords
- Polypoidal Choroidal Vasculopathy (PCV), Faricimab, Age-related macular degeneration
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Yeungnam University College of MedicineUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 10 Mar 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.
To evaluate the Efficacy of a personalized treat-and-extend regimen of faricimab for treatment-naive polypoidal choroidal vasculopathy
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Faricimab injection | Experimental | Drug: Faricimab Injection [Vabysmo]Initial Interval - All patients will enter the treat-and-extend (T\&E) phase with an initial injection interval of 8 weeks following the loading phase. Disease activity is defined as the presence of any of the following: * Intraretinal fluid (IRF) or subretinal fluid (SRF) on SD-OCT * Loss of ≥5 ETDRS letters from the previous visit associated with recurrent fluid * New or increased retinal/subretinal hemorrhage Injection Interval Adjustment Algorithm • Extension: If no signs of disease activity are observed, the injection interval may be extended by 4 weeks, up to a maximum of 24 weeks. • Shortening: If any disease activity is detected, the injection interval should be shortened by 4 weeks, to a minimum of 4 weeks. • Maintenance: If no disease activity is present but criteria for extension are not met (e.g., residual stable SRF or investigator discretion), the current interval is maintained. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (27 listed)
- 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.
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]After applying topical anesthetic drops, intravitreal injections were delivered with a 30-gauge needle placed 3.5-4.0 mm posterior to the limbus. Patients were treated with faricimab (6 mg/0.05 ml). | Drug | Faricimab injection |
Primary outcome
The proportion of patients who reached a treatment interval of ≥16 weeks at Week 96 (LV)
Time frame: Week 96
9 secondary outcomes
Central Subfield Thickness (CST) decrease change from baseline at visit Weeks 4, 8, 12, 16, and 96 (LV)
Time frame: Week 4, week 8, week 12, week 16, week 96
Proportion of patients who gain ≥10 letters and ≥15 letters in best corrected visual acuity (BCVA) from baseline at Week 96.
Time frame: Week 96
Proportion of patients who experienced the polypoidal regression (At weeks 12, 48, 96)
Time frame: Week 12, week 48, week 96
Choroidal thickness (at fovea center) at Baseline, at Weeks 12 , 48, 96
Time frame: Day 1, Week 12, week 48, week 96
Change in the thickness of the largest polyp and irregular pigment epithelial detachment (PED) as measured by spectral-domain OCT (SD-OCT) at Weeks 12 and 96
Time frame: Week 12, week 96
Proportion of patients with complete fluid resolution (no IRF or SRF) at Weeks 12 and 96.
Time frame: Week 12, week 96
Mean number of injections per patient at week 48 and week 96
Time frame: Week 48, week 96
Proportion of patients who maintain their last assigned injection interval at Week 96
Time frame: Week 96
Number of participants with treatment-related adverse events
Time frame: Through study completion, an average of 96 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 Mar 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Faricimab Injection [Vabysmo] in people with Polypoidal Choroidal Vasculopathy (PCV) and Age Related Macular Degeneration, run by Yeungnam University College of Medicine at 1 site 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 10 inclusion and 27 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 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients who reached a treatment interval of ≥16 weeks at Week 96 (LV) (time frame: Week 96). 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 Mar 2026.