Comparing Efficacy of 8-Week and 12-Week Faricimab Initial Follow-Up Treatment Intervals
1 other identifier
interventional
100
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Mar 2023
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 31, 2023
CompletedFirst Submitted
Initial submission to the registry
October 30, 2023
CompletedFirst Posted
Study publicly available on registry
March 13, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2026
CompletedMarch 13, 2025
March 1, 2025
2 years
October 30, 2023
March 10, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in CRT
Change in central subfield thickness (CST) over time as measured by SD-OCT
from baseline up to 56 weeks
Patients with intraretinal or subretinal fluid or serous pigment epithelium detachment after loading
Number of patients with subretinal, intraretinal fluid or pigment epithelium detachment (PED) at week 20 (Group 1) or week 24 (Group 2)
From baseline to week 20 (Group 1) or week 24 (Group 2)
Secondary Outcomes (4)
Change from baseline in BCVA
From baseline up to 56 weeks
Presence of fluid
From baseline up to 56 weeks
Number of injections
From baseline up to 56 weeks
Treatment interval
From baseline up to 56 weeks
Study Arms (2)
Group 1, 8-Week
EXPERIMENTALPatients in the first group will receive 4 injections of faricimab every 4 weeks, with the next visit and injection after 8 weeks (Week 20 Visit), followed by a treat-and-extend regimen with a minimal interval of 8 weeks and a maximal interval of 16 weeks.
Group 2, 12-Week
EXPERIMENTALPatients in the second group will also receive 4 loading doses with the next visit after an extended 12-week interval (Week 24 Visit). Following treatment, patients in this group will be on the same treat-and-extend regimen as patients in the first group.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Ophthalmology, Faculty hospital Kralovske Vinohrady
Prague, 100 34, Czechia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Martin Pencak, MD
+420 267 16 3637
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Investigator
Study Record Dates
First Submitted
October 30, 2023
First Posted
March 13, 2025
Study Start
March 31, 2023
Primary Completion
April 1, 2025
Study Completion
April 1, 2026
Last Updated
March 13, 2025
Record last verified: 2025-03