Actively Recruiting

Phase 3
Age: 50Years +
All Genders
NCT07461441

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

Led by Yeungnam University College of Medicine · Updated on 2026-03-10

50

Participants Needed

1

Research Sites

143 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 50Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Presence of active polypoidal lesions in the macula confirmed by indocyanine green angiography (ICGA) and exudative or hemorrhagic features involving the macula seen on color fundus photography, fluorescein angiography, and spectral domain optical coherence tomography (SD-OCT) with intraretinal or subretinal fluid affecting the central subfield
  • Best corrected visual acuity (BCVA) score between 24 and 78 letters at 4 meters using ETDRS charts at screening and baseline
  • Greatest linear dimension of the total lesion area less than 5400 micrometers as measured by ICGA
  • Signed informed consent form
  • Age 50 years or older at the time of consent
  • Ability to comply with study protocol as judged by investigator
  • For women of childbearing potential: agreement to abstain from heterosexual intercourse or use contraception as specified in protocol
Not Eligible

You will not qualify if you...

  • Previous treatment with anti-VEGF drugs, faricimab, or investigational drugs before baseline
  • Use of intraocular or periocular steroids within 6 months prior to baseline
  • Prior macular laser photocoagulation or photodynamic therapy before baseline, or peripheral laser photocoagulation within 3 months prior to baseline
  • Treatment with investigational therapies within 3 months before study day 1
  • Ocular disorders or conditions that could affect treatment response or study results, or require planned intervention during the first 12 months
  • Presence of subfoveal geographic atrophy, extensive retinal pigment epithelial atrophy, subfoveal fibrosis or scarring involving central subfield
  • Subretinal or sub-retinal pigment epithelial hemorrhage involving 50% or more of lesion area or hemorrhage obscuring fovea
  • Active intraocular or periocular infection or inflammation in either eye at screening or baseline
  • Uncontrolled glaucoma in study eye with intraocular pressure above 25 mmHg
  • Conditions mimicking polypoidal choroidal vasculopathy such as macular aneurysms or telangiectasia
  • History of idiopathic or autoimmune-associated uveitis in either eye
  • Systemic anti-VEGF therapy before baseline
  • Major illness or surgery within 1 month before screening
  • Active cancer within 12 months prior to study day 1 except certain treated cancers
  • Continuous use of prohibited medications or treatments
  • Systemic treatment for active or suspected infection on study day 1
  • Uncontrolled blood pressure above 180/100 mmHg at rest on study day 1
  • Stroke or heart attack within 6 months prior to study day 1
  • History of severe allergic or anaphylactic reaction to biologic agents or any study drug components
  • Pregnancy, breastfeeding, or intention to become pregnant during study or within 28 days after last dose

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Yeungnam university medical center

Daegu, Namgu, South Korea, 42415

Actively Recruiting

Loading map...

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here