A Phase 4 interventional study of Faricimab Injection in Wet Age-related Macular Degeneration, sponsored by Faculty Hospital Kralovske Vinohrady. Recruiting at 1 site in Czechia. Per ClinicalTrials.gov, last updated 2025-03-13.
Sponsored by Faculty Hospital Kralovske Vinohrady · Phase 4, Interventional, and Treatment
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.
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:
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
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This study's planned enrollment of 100 is above the median of 20 across 89 interventional studies indexed under Glycogen Storage Disease Type II.
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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
Exclusion Criteria:
Myocardial Infarction or Stroke in the last 3 months
Previous or current conditions of the study eye:
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 to any component contained in the study drug
r. pregnant or breastfeeding women
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Faricimab Injection
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.
Drug: Faricimab Injection
Intravitreal Injection
Change in CRT
Change in central subfield thickness (CST) over time as measured by SD-OCT
Time frame: 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)
Time frame: From baseline to week 20 (Group 1) or week 24 (Group 2)
Change from baseline in BCVA
Change in best-corrected visual acuity over time as measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters
Time frame: From baseline up to 56 weeks
Presence of fluid
Proportion of patients with presence of central retina intraretinal fluid, subretinal fluid, and both at final study visit
Time frame: From baseline up to 56 weeks
Number of injections
Number of faricimab injections received during the study duration.
Time frame: From baseline up to 56 weeks
Treatment interval
The proportion of patients on a every 4 weeks (Q4w) to every 8 weeks (Q8W), Q8W to every 12 weeks (Q12W), and Q12W to every 16 weeks (Q16W) treatment interval during the study
Time frame: From baseline up to 56 weeks
Plan to share: Undecided
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