Efficacy and Durability of a Personalized Treat-and-extend Regimen of Faricimab for Treatment-nai… (NCT07461441) | Clinical Trial Compass
RecruitingPhase 3
Efficacy and Durability of a Personalized Treat-and-extend Regimen of Faricimab for Treatment-naive Polypoidal Choroidal Vasculopathy
South Korea50 participantsStarted 2026-03-01
Plain-language summary
To evaluate the Efficacy of a personalized treat-and-extend regimen of faricimab for treatment-naive polypoidal choroidal vasculopathy
Who can participate
Age range50 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
What they're measuring
1
The proportion of patients who reached a treatment interval of ≥16 weeks at Week 96 (LV)