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Recruiting Phase 4

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

NCT06875245 · tracked via the Priya Life Science Czechia tracker
Phase
Phase 4
Started
2023-03-31
Last updated
2025-03-13

Condition(s) studied

Wet Age-related Macular Degeneration

Investigational drug(s) / intervention(s)

Faricimab Injection →

Faricimab Injection: Intravitreal Injection

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.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria: 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 Criteria: Myocardial Infarction or Stroke in the last 3 months Previous or current conditions of the study eye: 1. subretinal haemorrhage comprising more than 25% of the lesion in the study eye 2. scar or fibrosis comprising more than 50% of the lesion in the study eye 3. presence of retinal pigment epithelium (RPE) tears or ruptures in the central 1 mm of the macula in the study eye 4. total lesion size more than 8 papillary diameters (PD) as per OCT and FP examination 5. uncontrolled glaucoma in the study eye defined as IOP of more than 25 mmHg despite the antiglaucoma treatment 6. idiopathic or autoimmune uveitis in the study eye 7. 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

Primary outcome measure(s)

  • Change in CRT — from baseline up to 56 weeks
    Change in central subfield thickness (CST) over time as measured by SD-OCT
  • Patients with intraretinal or subretinal fluid or serous pigment epithelium detachment after loading — From baseline to week 20 (Group 1) or week 24 (Group 2)
    Number of patients with subretinal, intraretinal fluid or pigment epithelium detachment (PED) at week 20 (Group 1) or week 24 (Group 2)

Trial sites (1)

FacilityCityRegionStatus
Department of Ophthalmology, Faculty hospital Kralovske Vinohrady Prague Czechia Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06875245 on ClinicalTrials.gov ↗ ← All trials in Czechia