[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100583355":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":25,"centralContacts":30,"locations":37,"responsibleParty":54,"collaborators":24,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":24,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":24,"maxAge":24,"enrollmentInfo":65,"targetDuration":24,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":74,"overallStatus":40,"whyStopped":24,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Faculty Hospital Kralovske Vinohrady","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1, 8-Week","EXPERIMENTAL","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.",[13],"Drug: Faricimab Injection",{"label":15,"type":10,"description":16,"interventionNames":17},"Group 2, 12-Week","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.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Faricimab Injection","Intravitreal Injection",[9,15],null,[26],{"name":27,"affiliation":28,"role":29},"Martin Pencak, MD","+420 267 16 3637","PRINCIPAL_INVESTIGATOR",[31,34],{"name":27,"role":32,"phone":28,"phoneExt":24,"email":33},"CONTACT","martin.pencak@fnkv.cz",{"name":35,"role":32,"phone":28,"phoneExt":24,"email":36},"Patrik Rajs, MD","patrik.rajs@fnkv.cz",[38],{"facility":39,"status":40,"city":41,"state":24,"zip":42,"country":43,"countryCode":24,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Department of Ophthalmology, Faculty hospital Kralovske Vinohrady","RECRUITING","Prague","100 34","Czechia",{"type":45,"coordinates":46},"Point",[47,48],14.42076,50.08804,{"lat":48,"lon":47},[51],{"name":52,"role":32,"phone":28,"phoneExt":24,"email":53},"Martin Pencak, M.D.","pencak@volny.cz",{"type":29,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Martin Pencak","Investigator","100583355","phase-4-comparing-efficacy-of-8-week-and-12-week-faricimab-initial-follow-up-treatment-intervals-100583355",false,"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","Inclusion Criteria:\n\nActive treatment naïve CNV (Type 1, Type 2, or Type 3) in the macula including fovea diagnosed on OCT and OCTA\n\nBCVA between 70 to 35 ETDRS letters (approx. 20\u002F40 to 20\u002F200 Snellen equivalent) decrease in BCVA caused primarily by the CNV in the study eye\n\npresence of intra- or subretinal fluid or PED in the central 1 mm of the macula on the OCT\n\npatient capable of signing the informed consent\n\nExclusion Criteria:\n\nMyocardial Infarction or Stroke in the last 3 months\n\nPrevious or current conditions of the study eye:\n\n1. subretinal haemorrhage comprising more than 25% of the lesion in the study eye\n2. scar or fibrosis comprising more than 50% of the lesion in the study eye\n3. presence of retinal pigment epithelium (RPE) tears or ruptures in the central 1 mm of the macula in the study eye\n4. total lesion size more than 8 papillary diameters (PD) as per OCT and FP examination\n5. uncontrolled glaucoma in the study eye defined as IOP of more than 25 mmHg despite the antiglaucoma treatment\n6. idiopathic or autoimmune uveitis in the study eye\n7. 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.)\n\nk. significant opacities of the ocular media in the study eye including cataract, which can interfere with BCVA assessment or OCT examination\n\nn. diabetic retinopathy, diabetic macular edema or any other retinal vascular disease in the study eye\n\no. extraocular or periocular infection or inflammation (e.g. blepharitis, keratitis, conjunctivitis, scleritis, etc.) in any eye at the time of screening or baseline visit\n\np. any intraocular infection or inflammation in any eye during 12 weeks (84 days) before the screening visit\n\nq. allergy or hypersensitivity to any component contained in the study drug\n\nr. pregnant or breastfeeding women","ALL",{"count":66,"type":67},100,"ESTIMATED","INTERVENTIONAL",[70],"PHASE4","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.\n\nPatients 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.\n\nPatients 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.",[73],"Wet Age-related Macular Degeneration",[75,76,77,78],"retina","amd","faricimab","macula","2025-03-10",{"date":81,"type":82},"2025-03-13","ACTUAL",{"date":84,"type":82},"2023-03-31",{"date":86,"type":67},"2026-04",{"name":5,"class":6},1]