Efficacy and Durability of a Personalized Treat-and-extend Regimen of Faricimab for Treatment-naive Polypoidal Choroidal Vasculopathy (HANGANG)

To evaluate the Efficacy of a personalized treat-and-extend regimen of faricimab for treatment-naive polypoidal choroidal vasculopathy

Study Overview

• Status: Recruiting
• Conditions: Age Related Macular Degeneration; Polypoidal Choroidal Vasculopathy (PCV)
• Intervention / Treatment: Drug: Faricimab Injection [Vabysmo]

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 3

Contacts and Locations

Study Locations

• South Korea
  • Namgu
    • Daegu, Namgu, South Korea, 42415
      • Recruiting
      • Yeungnam University Medical Center
      • Contact: Min Sagong, Professor; Phone Number: 82536203215; Email: ey005@ymc.yu.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Faricimab injection; 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.

Drug: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The proportion of patients who reached a treatment interval of ≥16 weeks at Week 96 (LV)	Week 96

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.		Week 96
Proportion of patients who experienced the polypoidal regression (At weeks 12, 48, 96)		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	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		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	Week 12, week 96
Mean number of injections per patient at week 48 and week 96		Week 48, week 96
Proportion of patients who maintain their last assigned injection interval at Week 96		Week 96
Number of participants with treatment-related adverse events		Through study completion, an average of 96 weeks

Collaborators and Investigators

• Sponsor: Yeungnam University College of Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): November 30, 2028
• Study Completion (Estimated): November 30, 2028

Study Registration Dates

• First Submitted: February 14, 2026
• First Submitted That Met QC Criteria: March 5, 2026
• First Posted (Actual): March 10, 2026

Study Record Updates

• Last Update Posted (Actual): March 10, 2026
• Last Update Submitted That Met QC Criteria: March 5, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Age-related macular degeneration; Faricimab; Polypoidal Choroidal Vasculopathy (PCV)
• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Uveal Diseases; Retinal Diseases; Retinal Degeneration; Choroid Diseases; Metaplasia; Choroidal Neovascularization; Neovascularization, Pathologic; Pathological Conditions, Signs and Symptoms; Polypoidal Choroidal Vasculopathy; Macular Degeneration; faricimab
• Other Study ID Numbers: YUMC 2025-12-022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No