Actively Recruiting
Comparing Efficacy of 8-Week and 12-Week Faricimab Initial Follow-Up Treatment Intervals
Led by Faculty Hospital Kralovske Vinohrady · Updated on 2025-03-13
100
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Comparing Efficacy of 8-Week and 12-Week Faricimab Initial Follow-Up Treatment Intervals
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Active treatment-nafve choroidal neovascularization (CNV) of Type 1, 2, or 3 in the macula including the fovea confirmed by OCT and OCT angiography
- Best corrected visual acuity (BCVA) between 70 and 35 ETDRS letters (approximate 20/40 to 20/200 Snellen equivalent) primarily caused by CNV in the study eye
- Presence of intra- or subretinal fluid or pigment epithelial detachment (PED) in the central 1 mm of the macula on OCT
- Patient is able to provide informed consent
You will not qualify if you...
- Myocardial infarction or stroke within the last 3 months
- Subretinal hemorrhage covering more than 25% of the lesion in the study eye
- Scar or fibrosis covering more than 50% of the lesion in the study eye
- Retinal pigment epithelium (RPE) tears or ruptures in the central 1 mm of the macula in the study eye
- Total lesion size greater than 8 papillary diameters as per OCT and fundus photography
- Uncontrolled glaucoma in the study eye with intraocular pressure above 25 mmHg despite treatment
- Idiopathic or autoimmune uveitis in the study eye
- Other macular pathologies unrelated to AMD that may affect vision (e.g., macular hole, epiretinal membrane)
- Significant opacities in the ocular media including cataract that interfere with vision or OCT assessment
- Diabetic retinopathy, diabetic macular edema, or other retinal vascular diseases in the study eye
- Extraocular or periocular infection or inflammation in any eye at screening or baseline
- Any intraocular infection or inflammation in any eye within 12 weeks before screening
- Allergy or hypersensitivity to any component of the study drug
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Department of Ophthalmology, Faculty hospital Kralovske Vinohrady
Prague, Czechia, 100 34
Actively Recruiting
Research Team
M
Martin Pencak, MD
CONTACT
P
Patrik Rajs, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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