Comparing Efficacy of 8-Week and 12-Week Faricimab Initial Follow-Up Treatment Intervals

Comparing Efficacy of 8-Week and 12-Week Faricimab Initial Follow-Up Treatment Intervals Following 4 Loading Doses - Prospective Randomised Study

Comparing Efficacy of 8-Week and 12-Week Faricimab Initial Follow-Up Treatment Intervals (NCT06875245) is a Phase 4 interventional studying Wet Age-related Macular Degeneration, sponsored by Faculty Hospital Kralovske Vinohrady. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 4 studies happen after a treatment has been approved by the FDA. They monitor long-term safety, real-world effectiveness, and any rare side effects that only emerge in larger populations over longer periods. Phase 4 results sometimes lead to label changes, additional warnings, or — rarely — withdrawal of approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 100 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Wet Age-related Macular Degeneration subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 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 willing to sign a consent form Who Should NOT Join This Trial: 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 Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

DRUG

Faricimab Injection

Intravitreal Injection

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Department of Ophthalmology, Faculty hospital Kralovske Vinohrady

Prague, Czechia

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06875245), the sponsor (Faculty Hospital Kralovske Vinohrady), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06875245 clinical trial studying?

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 rece… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06875245?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06875245?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06875245. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06875245. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.