Comparing Efficacy of 8-Week and 12-Week Faricimab Initial Follow-Up Treatment Intervals
NCT06875245 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2025-03-13
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.
Conditions
Interventions
- DRUG
-
Faricimab Injection
Intravitreal Injection
Sponsors & Collaborators
-
Faculty Hospital Kralovske Vinohrady
lead OTHER_GOV
Principal Investigators
-
Martin Pencak, MD · +420 267 16 3637
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-03-31
- Primary Completion
- 2025-04-30
- Completion
- 2026-04-30
Countries
- Czechia
Study Locations
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