Late-Onset Retinal Degeneration Clinical Trials

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

Status: Recruiting

Location: See location...

Intervention Type: Drug

Study Type: Interventional

Study Phase: Phase 3

SUMMARY

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

Eligibility

Participation Requirements

Sex: All

Minimum Age: 50

Healthy Volunteers: f

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⁃ 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)

Locations

Other Locations

Republic of Korea

Yeungnam university medical center

RECRUITING

Daegu

Time Frame

Start Date: 2026-03-01

Estimated Completion Date: 2028-11-30

Participants

Target number of participants: 50

Treatments

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.

Related Therapeutic Areas

Late-Onset Retinal Degeneration

Age-Related Macular Degeneration (ARMD)

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