ClinicalTrials.gov record NCT06875245
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
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This randomized study compares two schedules for the first follow-up after four monthly faricimab eye injections for wet AMD. It enrolls people with active, treatment‑naïve choroidal neovascularization confirmed by OCT/OCTA and follows them about 44–56 weeks. The study measures vision (BCVA), retinal thickness on OCT, and how many injections patients receive.
What it is studying. The study tests whether scheduling the first follow-up visit and injection at 8 weeks versus 12 weeks after four monthly faricimab loading doses leads to differences in best-corrected visual acuity, central retinal thickness on OCT, and the total number of injections over the study period.
What the researchers hope to learn. To compare changes in central retinal thickness and the presence of retinal fluid after the two initial follow-up intervals; to compare changes in best-corrected visual acuity, the presence of fluid at study end, the number of faricimab injections given, and the distribution of treatment intervals during the study.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Drug
- Faricimab Injection
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
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:
- 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
Study description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Show the detailed description from the registry
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 neovascularization (CNV) with intravitreal antiVEGF drugs is highly effective. In our study, we aim to compare the efficacy of standard (8 weeks) versus extended follow-up dosing interval (12 weeks) following 4 monthly loading injections of the new combined-mechanism medication, faricimab (6 mg intravitreal dose), which targets both VEGF-A and Ang-2 receptors, in the treatment of wet AMD. We will include all types of CNVs in our study, including Type 1 (occult), Type 2 (classic), Type 3 CNV (Retinal Angiomatous Proliferation = RAP) and mixed CNV. This is a prospective, randomised, comparative study comparing the best corrected visual acuity (BCVA) and central retinal thickness (CRT) on optical coherence tomography (OCT) in the 20th, 24th week of the study between both groups. The total number of injections between both groups will be also compared at the final visit, which will take place between the 44th and 56th week of the study based on the dosing interval. Patients 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. Patients 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. The study will compare best corrected visual acuity (BCVA), central retinal thickness (CRT) on OCT, and the number of injections between both groups. Visit plan: Screening visit - 14 to 0 day prior to baseline. Informed consent will be signed prior to any other study procedures. Ocular and medical history will be written down. BCVA of both eyes will be tested on ETDRS charts. Non-contact intraocular pressure (IOP) will be measured. Slit lamp anterior segment examination and fundus biomicroscopy of both eyes will be performed in artificial mydriasis. The OCT scan of both eyes will be performed, and OCTA will be performed in the treatment naïve eyes. Based on the examination results, patients' eligibility for the study will be assessed. Baseline - day 1 - BCVA of both eyes will be tested on ETDRS charts. Non-contact IOP will be measured. Slit lamp anterior segment examination and fundus biomicroscopy of both eyes will be performed with artificial mydriasis. OCT of both eyes will be performed. Based on the examination results, patients' eligibility for the study will be assessed. Eligible patients will be randomised, and study medication will be given. Week 4, Week 8, and Week 12 - adverse events connected to study drugs or study procedures will be assessed and study medication will be given. Extension Visit Week 20 (group 1) or Week 24 (group 2) - After an initial loading phase of four monthly doses, the two groups differ in the length of the extended dosing intervals. Adverse events connected to study drugs or study procedures will be assessed. BCVA of both eyes will be tested on ETDRS charts. Slit lamp anterior segment examination and fundus biomicroscopy of both eyes will be performed in artificial mydriasis. OCT of both eyes will be performed. Study medication will be given. Next treatment visit will be scheduled based on the disease activity on the OCT, the ocular examination findings and the BCVA in treat-and-extend regimen with minimal interval of 8 weeks and maximal interval of 16 weeks. The therapeutic interval in both groups may be extended or shortened in up to 4-week increments based on the patient's visual acuity and disease activity, as assessed by OCT evaluating the presence or absence of subretinal or intraretinal fluid or pigment epithelial detachment (PED) and on the presence of other signs of disease activity on the fundus examination (haemorrhage, hard exudates, etc.). It is up to the investigator to make the final decision on the treatment interval. Follow-up Visits Week 20 to Week 56 - Treat-and-extend regimen. Adverse events connected to study drugs or study procedures will be assessed. BCVA of both eyes will be tested on ETDRS charts. Non-contact IOP will be measured. Slit lamp anterior segment examination and fundus biomicroscopy of both eyes will be performed in artificial mydriasis. OCT of both eyes will be performed. Study medication will be given. Next treatment visit will be scheduled based on the disease activity as described above (treat-and-extend regimen with possible up to 4-week adjustments). End of Study Visit Week 44-56 - Adverse events assessment. BCVA of both eyes will be tested on ETDRS charts. Slit lamp anterior segment examination and fundus biomicroscopy of both eyes will be performed in artificial mydriasis. OCT of both eyes will be performed. OCTA of the study eye (SE) will be performed. Study procedures: OCT - performed on Spectralis OCT (Heidelberg Engineering GmbH, Heidelberg, Germany). CRT will be assessed from automatic retinal thickness analysis in 9 ETDRS subfields including the central subfield. 49 horizontal scans in the angle of 20x20° 123 um apart in High resolution mode with noise reduction set to ART=4 will be performed. OCTA - performed on Spectralis OCT (Heidelberg Engineering GmbH, Heidelberg, Germany). 512 horizontal scans in the angle of 20x20° 11 um apart in High-speed mode with noise reduction set to ART=5 will be performed. Disease activity assessment: Based on the decision of the investigator. Shortening of the treatment interval is recommended when the BCVA decrease of more than 5 ETDRS letters is observed, in case of intra- or subretinal fluid or PED reappearance or increase on the OCT or when new haemorrhage or hard exudates are observed in the macula. Extension of the treatment interval is recommended in the absence of intra- and subretinal fluid and PED on the OCT with better or stable BCVA, or in case the BCVA and OCT findings are stable after 3 injections in the shortest possible interval. Rescue therapy: Aflibercept may be given as a rescue therapy in case of patients with study drug related sight threatening adverse events or with worsening of BCVA and OCT findings even on the shortest treatment interval when resistance to study drug is suspected. Switch to rescue therapy must be consulted with and approved by principal investigator. Eligibility 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:
- 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
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
After giving informed consent, participants receive four monthly intravitreal faricimab injections (baseline, weeks 4, 8, 12) and are randomized to either an 8‑week or 12‑week initial extension visit. Visits include vision testing (ETDRS BCVA), eye exam (slit lamp and dilated fundus exam), intraocular pressure checks, OCT at most visits, OCT angiography at screening (in treatment‑naïve eye) and at the end of study, and assessment of adverse events. After the initial extension visit (week 20 or 24), participants follow a treat‑and‑extend schedule with injections and visits adjusted between 8 and 16 weeks based on OCT and vision; total follow‑up occurs through weeks 44–56. Rescue treatment with aflibercept is possible if sight‑threatening adverse events or worsening despite the shortest interval occur (requires principal investigator approval).
How the study is structured. Interventional, randomized, open-label (no masking), parallel-group study. All participants receive four monthly intravitreal faricimab injections (6 mg). After the loading doses they are randomized to an initial follow-up at either 8 weeks or 12 weeks, then managed with a treat‑and‑extend schedule with intervals adjusted in 4‑week steps (minimum 8 weeks, maximum 16 weeks). Participants have regular eye exams, OCT (and OCTA at specified visits), and vision testing over about 44–56 weeks.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- The registry lists this study under Wet Age-related Macular Degeneration. Does it apply to my diagnosis?
- The listed sites are in Czechia. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on Pompe disease
Important dates
- Study start
- Mar 31, 2023
- Primary completion
- April 2025 (estimated)
- Study completion
- April 2026 (estimated)
- Target enrollment
- 100 participants (estimated)
- Last updated on registry
- Mar 13, 2025
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Faculty Hospital Kralovske Vinohrady
- Principal investigator
- Martin Pencak, Investigator
Faculty Hospital Kralovske Vinohrady
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Martin Pencak, MD 📞 +420 267 16 3637 ✉ martin.pencak@fnkv.cz
- Patrik Rajs, MD 📞 +420 267 16 3637 ✉ patrik.rajs@fnkv.cz
Participating sites (1)
- Department of Ophthalmology, Faculty hospital Kralovske VinohradyRecruiting
Prague, 100 34 · Czechia
- Martin Pencak, M.D. · +420 267 16 3637 · pencak@volny.cz
Terms used on this page · explanations by MedicalUpdates.ai
- randomized
- Participants are assigned to the study groups by chance, like a coin toss, rather than chosen by the doctor or the participant. This is done so the groups are comparable.
- follow-up
- The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
- informed consent
- The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
- baseline
- Measurements taken at the start of the study, before any study treatment, so that later results can be compared with them.
- screening visit
- The checks done before enrolment to see whether a person qualifies, such as tests, scans or a review of medical history.
- study drug
- A treatment that is being tested and has not been approved for this use. It may be approved for a different condition. Being studied does not mean it works or is available outside the study.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
- adverse events
- Any unwanted medical problem that happens during a study, whether or not it was caused by the treatment. A 'serious' adverse event is one that meets specific criteria, such as causing death, being life-threatening, requiring or prolonging hospital admission, causing significant disability, or another medically important outcome.
- principal investigator
- The doctor or scientist responsible for running the study at a site or overall.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
← Back to clinical trials