Status:
RECRUITING
Comparing Efficacy of 8-Week and 12-Week Faricimab Initial Follow-Up Treatment Intervals
Lead Sponsor:
Faculty Hospital Kralovske Vinohrady
Conditions:
Wet Age-related Macular Degeneration
Eligibility:
All Genders
Phase:
PHASE4
Brief 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 coherenc...
Detailed Description
Wet age-related macular degeneration (wet AMD) is a progressive eye disease that affects the macula, the part of the retina responsible for sharp central vision. The treatment of wet AMD choroidal neo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 31 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06875245
Start Date
March 31 2023
End Date
April 1 2026
Last Update
March 13 2025
Active Locations (1)
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1
Department of Ophthalmology, Faculty hospital Kralovske Vinohrady
Prague, Czechia, 100 34