NCT06875245 Comparing Efficacy of 8-Week and 12-Week Faricimab Initial Follow-Up Treatment Intervals
| NCT ID | NCT06875245 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Faculty Hospital Kralovske Vinohrady |
| Condition | Wet Age-related Macular Degeneration |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-03-31 |
| Primary Completion | 2025-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 100 participants in total. It began in 2023-03-31 with a primary completion date of 2025-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Martin Pencak, MD
PRINCIPAL INVESTIGATOR
+420 267 16 3637
Frequently Asked Questions
Who can join the NCT06875245 clinical trial?
This trial is open to participants of all sexes, studying Wet Age-related Macular Degeneration. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06875245 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06875245 currently recruiting?
Yes, NCT06875245 is actively recruiting participants. Contact the research team at martin.pencak@fnkv.cz for enrollment information.
Where is the NCT06875245 trial being conducted?
This trial is being conducted at Prague, Czechia.
Who is sponsoring the NCT06875245 clinical trial?
NCT06875245 is sponsored by Faculty Hospital Kralovske Vinohrady. The principal investigator is Martin Pencak, MD at +420 267 16 3637. The trial plans to enroll 100 participants.