RecruitingPhase 4NCT06875245

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

Comparing Efficacy of 8-Week and 12-Week Faricimab Initial Follow-Up Treatment Intervals Following 4 Loading Doses - Prospective Randomised Study

Sponsor

Faculty Hospital Kralovske Vinohrady

Enrollment

100 participants

Start Date

Mar 31, 2023

Study Type

INTERVENTIONAL

Conditions

wet age related macular degeneration

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.

Eligibility

Inclusion Criteria4

Active treatment naïve CNV (Type 1, Type 2, or Type 3) in the macula including fovea diagnosed on OCT and OCTA
BCVA between 70 to 35 ETDRS letters (approx. 20/40 to 20/200 Snellen equivalent) decrease in BCVA caused primarily by the CNV in the study eye
presence of intra- or subretinal fluid or PED in the central 1 mm of the macula on the OCT
patient capable of signing the informed consent

Exclusion Criteria15

Myocardial Infarction or Stroke in the last 3 months
Previous or current conditions of the study eye:
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
uncontrolled glaucoma in the study eye defined as IOP of more than 25 mmHg despite the antiglaucoma treatment
idiopathic or autoimmune uveitis in the study eye
other pathologies in the macula of the study eye unrelated to AMD which can be expected to influence the BCVA (e.g. macular hole, epiretinal membrane, etc.)
k. significant opacities of the ocular media in the study eye including cataract, which can interfere with BCVA assessment or OCT examination
n. diabetic retinopathy, diabetic macular edema or any other retinal vascular disease in the study eye
o. extraocular or periocular infection or inflammation (e.g. blepharitis, keratitis, conjunctivitis, scleritis, etc.) in any eye at the time of screening or baseline visit
p. any intraocular infection or inflammation in any eye during 12 weeks (84 days) before the screening visit
q. allergy or hypersensitivity to any component contained in the study drug
r. pregnant or breastfeeding women