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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorFaculty Hospital Kralovske Vinohrady

About this trial

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.

Eligibility criteria

Qualifiers

None

Disqualifiers

subretinal haemorrhage comprising more than 25% of the lesion in the study eye

scar or fibrosis comprising more than 50% of the lesion in the study eye

presence of retinal pigment epithelium (RPE) tears or ruptures in the central 1 mm of the macula in the study eye

total lesion size more than 8 papillary diameters (PD) as per OCT and FP examination

Trial design

Treatments tested in this trial

  • Faricimab Injection

Treatment groups

100 Participants
are divided into 2 treatment groups