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Comparing Efficacy of 8-Week and 12-Week Faricimab Initial Follow-Up Treatment Intervals

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated March 13, 2025 (before its estimated April 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Minor Study First Submitted
This is a prospective, randomized study that compares 8-week and 12-week follow-up intervals after the 4 monthly injections in the loading phase. Patients with active CNV confirmed on optical coherence tomography (OCT) and OCT angiography (OCTA) will be randomized into two groups and followed for 44 to 56 weeks. Patients in the first group will receive 4 injections of faricimab every 4 weeks, with the next visit and injection after 8 weeks, followed by a treat-and-extend regimen with a minimal interval of 8 weeks and a maximal interval of 16 weeks. Patients in the second group will also receive 4 loading doses with the next visit after an extended 12-week interval. Following treatment, patients in this group will be on the same treat-and-extend regimen as patients in the first group. The study will compare best corrected visual acuity (BCVA), central retinal thickness (CRT) on OCT, and the number of injections between both groups.
Trial Details
NCT Number NCT06875245
Lead Sponsor Faculty Hospital Kralovske Vinohrady
Conditions
(from sponsor)
Wet Age-related Macular Degeneration
Related terms Glycogen Storage Disease Type II
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov