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

NCT07461441 | Recruiting Phase 3

• 1 other identifier: YUMC 2025-12-022
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Polypoidal Choroidal Vasculopathy (PCV); Age Related Macular Degeneration

Keywords

Polypoidal Choroidal Vasculopathy (PCV); Faricimab; Age-related macular degeneration

Outcome Measures

Primary Outcomes (1)

• The proportion of patients who reached a treatment interval of ≥16 weeks at Week 96 (LV)

  Week 96

Secondary Outcomes (9)

• Central Subfield Thickness (CST) decrease change from baseline at visit Weeks 4, 8, 12, 16, and 96 (LV)

  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

  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

Study Arms (1)

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.

Drug: Faricimab Injection [Vabysmo]

Interventions

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).

Faricimab injection

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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:

Sponsors & Collaborators

• Yeungnam University College of Medicine: lead

Study Sites (1)

Yeungnam university medical center

Daegu, Namgu, 42415, South Korea

RECRUITING

MeSH Terms

Conditions

Polypoidal Choroidal Vasculopathy; Macular Degeneration

Interventions

faricimab

Condition Hierarchy (Ancestors)

Choroidal Neovascularization; Choroid Diseases; Uveal Diseases; Eye Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Retinal Degeneration; Retinal Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 14, 2026
• First Posted: March 10, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): November 30, 2028
• Study Completion (Estimated): November 30, 2028
• Last Updated: March 10, 2026

Record last verified: 2026-03

Locations

KR (1)