Actively Recruiting
Comparing Efficacy of 8-Week and 12-Week Faricimab Initial Follow-Up Treatment Intervals Following 4 Loading Doses - Prospective Randomised Study
Led by Faculty Hospital Kralovske Vinohrady · Updated on 2025-03-13
100
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to compare two different follow-up schedules after initial treatment for wet age-related macular degeneration (wet AMD) involving choroidal neovascularization (CNV). The study evaluates the effects of 8-week versus 12-week intervals following four monthly injections of faricimab, a medication targeting both VEGF-A and Ang-2 receptors. It includes patients with active CNV types diagnosed by optical coherence tomography (OCT) and OCT angiography (OCTA), focusing on visual acuity and retinal thickness outcomes. Participants are randomly assigned to one of two groups. The first group receives four injections of faricimab every four weeks, followed by an 8-week interval before the next injection, then a treat-and-extend regimen with intervals ranging from 8 to 16 weeks. The second group also receives four monthly injections but waits 12 weeks before the next visit and injection, then follows the same treat-and-extend approach. The study includes a screening visit, baseline assessments, loading doses at weeks 4, 8, and 12, extension visits at weeks 20 or 24, ongoing treat-and-extend visits up to week 56, and a final visit between weeks 44 and 56. Throughout the study, participants undergo regular eye exams including visual acuity testing, intraocular pressure measurement, slit lamp and fundus examinations, OCT and OCTA scans, and safety assessments. Researchers monitor changes in best corrected visual acuity (BCVA), central retinal thickness (CRT), presence of retinal fluid, and number of injections. Treatment intervals are adjusted based on disease activity and visual outcomes. The study also allows rescue therapy with aflibercept if necessary due to adverse effects or worsening symptoms.
CONDITIONS
Brief 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 naive choroidal neovascularization (Type 1, Type 2, or Type 3) in the macula including fovea diagnosed by OCT and OCTA
- Best corrected visual acuity between 70 to 35 ETDRS letters (approx. 20/40 to 20/200 Snellen equivalent) decreased primarily due to CNV in the study eye
- Presence of intra- or subretinal fluid or pigment epithelial detachment in the central 1 mm of the macula on OCT
- Patient capable of signing 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 tears or ruptures in the central 1 mm of the macula in the study eye
- Total lesion size more than 8 papillary diameters by OCT and fundus photography
- Uncontrolled glaucoma with intraocular pressure over 25 mmHg despite treatment
- Idiopathic or autoimmune uveitis in the study eye
- Other macular diseases unrelated to AMD affecting vision (e.g., macular hole, epiretinal membrane)
- Significant opacities like cataract interfering with vision or OCT
- Diabetic retinopathy, diabetic macular edema, or other retinal vascular diseases in the study eye
- Extraocular or periocular eye infections or inflammation at screening or baseline
- Any intraocular infection or inflammation within 12 weeks before screening
- Allergy or hypersensitivity to any component of the study drug
- Pregnant or breastfeeding women
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 56 weeks
Participants receive 4 monthly injections of faricimab followed by either an 8-week or 12-week follow-up interval, then continue treatment with a treat-and-extend regimen where dosing intervals range between 8 to 16 weeks based on disease activity and visual acuity.
Visits at baseline, Weeks 4, 8, 12, Week 20 (Group 1) or Week 24 (Group 2), then treat-and-extend visits every 8 to 16 weeks
Duration - From Week 20 or 24 up to Week 56
Participants continue on a treat-and-extend regimen with dosing intervals adjusted based on visual acuity and disease activity, with monitoring of adverse events and ocular assessments.
Multiple follow-up visits scheduled every 8 to 16 weeks during treat-and-extend phase
Duration - 1 day
Final assessments including visual acuity, eye examinations, OCT, and OCTA imaging are performed to evaluate treatment outcomes.
1 visit (in-person) between Week 44 and Week 56
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
P
Patrik Rajs, MD
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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