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

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

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

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