drugset / Trial / NCT06875245

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

NCT06875245

Phase 4 Recruiting 100 enrolled Faculty Hospital Kralovske Vinohrady
RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2023-03-31
Primary completion
2025-04
Completion
2026-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Faricimab Monoclonal antibody 6 mg Intravitreal