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

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06875245 on ClinicalTrials.gov