Clinical trial • Phase III | Phase IV • Ophthalmology
FARICIMAB for Neovascular age-related macular degeneration
Phase III | Phase IV trial of FARICIMAB for Neovascular age-related macular degeneration.
Overview
- Trial Therapeutic Area
- Ophthalmology
- Trial Disease
- Neovascular age-related macular degeneration
- Trial Stage
- Phase III | Phase IV
- Drug Modality
- Bispecific antibody
Key dates
- Initial CTIS Submission Date
- 12-02-2025
- First CTIS Authorization Date
- 02-06-2025
Trial design
Randomised, open-label, faricimab regimens in two arms: arm a (regimen exploring potential to reduce treatment burden associated with the initial loading period) vs arm b (treatment regimen based on the design of the lucerne and tenaya studies). specific doses and schedules not specified in the provided record.-controlled Phase III | Phase IV trial across 24 sites in France, Germany, Italy and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Faricimab regimens in two arms: Arm A (regimen exploring potential to reduce treatment burden associated with the initial loading period) vs Arm B (treatment regimen based on the design of the Lucerne and Tenaya studies). Specific doses and schedules not specified in the provided record.
- Target Sample Size
- 185
Eligibility
Recruits 185 Vulnerable population selected. Subject information and informed consent documents listed include 'L1_SIS and IAF infant authorization' and 'L1_SIS and ICF Infant Health' (infant authorization documents) and multiple ICF/SIS documents for adults, indicating specific consent/authorization materials for infants and other subjects are provided..
- Vulnerable Population
- Vulnerable population selected. Subject information and informed consent documents listed include 'L1_SIS and IAF infant authorization' and 'L1_SIS and ICF Infant Health' (infant authorization documents) and multiple ICF/SIS documents for adults, indicating specific consent/authorization materials for infants and other subjects are provided.
Inclusion criteria
- {"criterion_text":"- Age ≥50 years at the time of signing Informed Consent Form"}
- {"criterion_text":"- Overtly healthy as determined by medical evaluation that includes medical history and physical examination."}
- {"criterion_text":"- Agreement to adhere to the contraception requirements described"}
- {"criterion_text":"- Ocular Inclusion Criteria for Study Eye: Active treatment-naïve macular neovascularization (MNV) secondary to age-related macular degeneration (AMD), confirmed by the Investigator based on the presence of intraretinal fluid (IRF) or subretinal fluid (SRF) affecting the central subfield on OCT."}
- {"criterion_text":"- Ocular Inclusion Criteria for Study Eye: BCVA of 83 to 24 letters, inclusive (20/25 to 20/320 approximate Snellen equivalent, using the early treatment diabetic retinopathy study (ETDRS) protocol and addressed at the initial testing distance of 4 meters on Day 1)."}
- {"criterion_text":"- Ocular Inclusion Criteria for Study Eye:Sufficiently clear ocular media and adequate pupillary dilation to allow acquisition of good quality retinal images to confirm diagnosis."}
Exclusion criteria
- {"criterion_text":"- Macular neovascularization due to causes other than AMD, such as ocular histoplasmosis, trauma, pathological myopia, angioid streaks, choroidal rupture, or uveitis."}
- {"criterion_text":"- Retinal pigment epithelial tear involving the macula on Day 1"}
- {"criterion_text":"- Current vitreous hemorrhage on Day 1"}
- {"criterion_text":"- Prior periocular pharmacological or IVT treatment (including faricimab, anti-vascular endothelial growth factor (VEGF), or complement inhibitor medication) for other retinal diseases"}
- {"criterion_text":"- Ocular Exclusion Criteria for Fellow (Non-Study) Eye Participants who have a nonfunctioning fellow (non-study) eye, defined as either BCVA of hand motion or worse, or no physical presence of non-study eye (i.e., monocular), at both the screening and study Day 1 visits will be excluded from study entry"}
- {"criterion_text":"- Ocular Exclusion for Both Eyes Potential participants are excluded from the study if any of the following criteria apply: – History of idiopathic or autoimmune associated uveitis in either eye – Active ocular inflammation or suspected or active ocular or periocular infection in either eye on study Day 1"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Change from baseline in BCVA score as measured using the ETDRS VA chart at a starting distance of 4 meters","definition_or_measurement_approach":"BCVA measured using the ETDRS VA chart at a starting distance of 4 meters; endpoint is change from baseline averaged over specified weeks per protocol."}
Secondary endpoints
- {"endpoint_text":"- Change from baseline in BCVA averaged over Weeks 92, 96, and 100","definition_or_measurement_approach":"BCVA change from baseline averaged over Weeks 92, 96 and 100 (BCVA measurement per ETDRS protocol as used for primary endpoint)."}
- {"endpoint_text":"- Change from baseline in BCVA over time","definition_or_measurement_approach":"BCVA change from baseline measured over time (ETDRS VA chart protocol)."}
- {"endpoint_text":"- Change from baseline in central subfield thickness (CST) averaged over Weeks 44, 48, and 52","definition_or_measurement_approach":"Central subfield thickness (CST) change from baseline averaged over Weeks 44, 48 and 52; anatomical assessments are specified in protocol (e.g., OCT)."}
- {"endpoint_text":"- Change from baseline in CST averaged over Weeks 92, 96, and 100","definition_or_measurement_approach":"CST change from baseline averaged over Weeks 92, 96 and 100 (anatomic measurement using OCT per protocol)."}
- {"endpoint_text":"- Change from baseline in CST over time","definition_or_measurement_approach":"CST change from baseline measured over time (anatomical measurement, e.g., OCT)."}
- {"endpoint_text":"- Proportion of participants on a Q4W, Q8W, Q12W, Q16W, Q20W, and Q24W treatment interval at Weeks 52 and 100","definition_or_measurement_approach":"Proportion of participants assigned/maintaining specified dosing intervals (every 4, 8, 12, 16, 20, 24 weeks) at Weeks 52 and 100 as recorded in treatment schedule."}
- {"endpoint_text":"- Incidence and severity of ocular adverse events","definition_or_measurement_approach":"Recorded incidence and severity of ocular adverse events per safety reporting procedures in protocol."}
- {"endpoint_text":"- Incidence and severity of non-ocular adverse events","definition_or_measurement_approach":"Recorded incidence and severity of non-ocular adverse events per safety reporting procedures in protocol."}
Recruitment
- Planned Sample Size
- 185
- Recruitment Window Months
- 30
- Consent Approach
- Informed consent obtained using subject information sheets and informed consent forms (multiple ICF/SIS documents listed). Documents include main ICFs and infant authorization forms (e.g., 'L1_SIS and IAF infant authorization', 'L1_SIS and ICF Infant Health') and patient-facing study brochures in multiple languages (English, Spanish, French, Italian, German). Infant authorization/authorization forms are listed where applicable.
Methods
- K1_Recruitment arrangement (documented recruitment arrangements)
- K2_Recruitment material Advert
- K2_Recruitment material Clinical Trials Brochure (graphics and photos)
- K2_Recruitment material Flyer Light Creative 1
- K2_Recruitment material Flyer Light Creative 2
- K2_Recruitment material Poster 1
- K2_Recruitment material Poster 2
- K2_Recruitment material Study Brochure
- Flyers, posters and study brochures available in multiple languages (as per listed documents)
Geography
- Total Number Of Sites
- 24
- Total Number Of Participants
- 89
France
- Earliest CTIS Part Ii Submission Date
- 12-03-2025
- Latest Decision Or Authorization Date
- 14-07-2025
- Processing Time Days
- 124
- Number Of Sites
- 6
- Number Of Participants
- 22
Sites
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Ophtalmology
- Principal Investigator Name
- Aude Couturier
- Principal Investigator Email
- aude.couturier@aphp.fr
- Contact Person Name
- Aude Couturier
- Contact Person Email
- aude.couturier@aphp.fr
- Site Name
- Clinique De L'Union
- Department Name
- Ophtalmology
- Principal Investigator Name
- Xavier Benouaich
- Principal Investigator Email
- benouaich_xavier@yahoo.fr
- Contact Person Name
- Xavier Benouaich
- Contact Person Email
- benouaich_xavier@yahoo.fr
- Site Name
- Retina
- Department Name
- Ophtalmology
- Principal Investigator Name
- Hessam Razavi
- Principal Investigator Email
- centrestexupery37@gmail.com
- Contact Person Name
- Hessam Razavi
- Contact Person Email
- centrestexupery37@gmail.com
- Site Name
- Societe Civile De Moyens Des Docteurs Maury-Francais-Coscas-Favard-Krivosic
- Department Name
- Ophtalmology
- Principal Investigator Name
- Elise Philippakis
- Principal Investigator Email
- elise.philippakis@gmail.com
- Contact Person Name
- Elise Philippakis
- Contact Person Email
- elise.philippakis@gmail.com
- Site Name
- Selarl Retine Tourny
- Department Name
- Ophtalmology
- Principal Investigator Name
- Eric Fourmaux
- Principal Investigator Email
- arc@retinegallien.com
- Contact Person Name
- Eric Fourmaux
- Contact Person Email
- arc@retinegallien.com
- Site Name
- Hospices Civils De Lyon
- Department Name
- Ophtalmology
- Principal Investigator Name
- Corinne Dot
- Principal Investigator Email
- corinnedot.pro@hotmail.fr
- Contact Person Name
- Corinne Dot
- Contact Person Email
- corinnedot.pro@hotmail.fr
Germany
- Earliest CTIS Part Ii Submission Date
- 12-03-2025
- Latest Decision Or Authorization Date
- 21-01-2026
- Processing Time Days
- 315
- Number Of Sites
- 6
- Number Of Participants
- 22
Sites
- Site Name
- Universitaetsklinikum Wuerzburg AöR
- Department Name
- Augenklinik und Poliklinik
- Principal Investigator Name
- Andreas Berlin
- Principal Investigator Email
- augenklinik@ukw.de
- Contact Person Name
- Andreas Berlin
- Contact Person Email
- augenklinik@ukw.de
- Site Name
- Augenzentrum Am St Franziskus-Hospital Muenster
- Department Name
- Augenzentrum
- Principal Investigator Name
- Albrecht Lommatzsch
- Principal Investigator Email
- info@augen-franziskus.de
- Contact Person Name
- Albrecht Lommatzsch
- Contact Person Email
- info@augen-franziskus.de
- Site Name
- Universitaetsklinikum Ulm AöR
- Department Name
- Klinik für Augenheilkunde
- Principal Investigator Name
- Armin Wolf
- Principal Investigator Email
- sekretariat.augenklinik@uniklinik-ulm.de
- Contact Person Name
- Armin Wolf
- Contact Person Email
- sekretariat.augenklinik@uniklinik-ulm.de
- Site Name
- Rostock University Medical Center
- Department Name
- Klinik und Poliklinik für Augenheilkunde
- Principal Investigator Name
- Friederike Schaub
- Principal Investigator Email
- Friederike.Schaub@med.uni-rostock.de
- Contact Person Name
- Friederike Schaub
- Contact Person Email
- Friederike.Schaub@med.uni-rostock.de
- Site Name
- Augenzentrum Prof. Dr. Koch GmbH
- Department Name
- Augenzentrum
- Principal Investigator Name
- Svenja Deuchler
- Principal Investigator Email
- info@augenzentrumfrankfurt.de
- Contact Person Name
- Svenja Deuchler
- Contact Person Email
- info@augenzentrumfrankfurt.de
- Site Name
- Medizinische Hochschule Hannover
- Department Name
- Klinik für Augenheilkunde
- Principal Investigator Name
- Ekaterina Sokolenko
- Principal Investigator Email
- augenklinik.sekretariat@mh-hannover.de
- Contact Person Name
- Ekaterina Sokolenko
- Contact Person Email
- augenklinik.sekretariat@mh-hannover.de
Italy
- Earliest CTIS Part Ii Submission Date
- 14-04-2025
- Latest Decision Or Authorization Date
- 03-06-2025
- Processing Time Days
- 50
- Number Of Sites
- 6
- Number Of Participants
- 23
Sites
- Site Name
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
- Department Name
- Scienze Cliniche e di Comunità
- Principal Investigator Name
- Francesco Viola
- Principal Investigator Email
- francesco.viola@unimi.it
- Contact Person Name
- Francesco Viola
- Contact Person Email
- francesco.viola@unimi.it
- Site Name
- Azienda Ospedaliero-Universitaria Sant Andre
- Department Name
- UOD Oculistica
- Principal Investigator Name
- Gianluca Scuderi
- Principal Investigator Email
- gianluca.scuderi@uniroma1.it
- Contact Person Name
- Gianluca Scuderi
- Contact Person Email
- gianluca.scuderi@uniroma1.it
- Site Name
- Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I G M Lancisi G Salesi
- Department Name
- Medicina sperimentale e clinica, clinica oculistica
- Principal Investigator Name
- Marco Lupidi
- Principal Investigator Email
- marco.lupidi@ospedaliriuniti.marche.it
- Contact Person Name
- Marco Lupidi
- Contact Person Email
- marco.lupidi@ospedaliriuniti.marche.it
- Site Name
- Azienda Ospedaliero Universitaria Ospedali Riuniti
- Department Name
- Scienze Mediche e Chirurgiche
- Principal Investigator Name
- Cristiana Iaculli
- Principal Investigator Email
- cristiana.iaculli@unifg.it
- Contact Person Name
- Cristiana Iaculli
- Contact Person Email
- cristiana.iaculli@unifg.it
- Site Name
- Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
- Department Name
- Dipartimento Multidisciplinare di Specialità Medico-Chirurgiche e Odontoiatriche
- Principal Investigator Name
- Settimio Rossi
- Principal Investigator Email
- settimio.rossi@unicampania.it
- Contact Person Name
- Settimio Rossi
- Contact Person Email
- settimio.rossi@unicampania.it
- Site Name
- Multimedica S.p.A.
- Department Name
- Clinica Oculistica Universitaria
- Principal Investigator Name
- Stela Vujosevic
- Principal Investigator Email
- stela.vujosevic@unimi.it
- Contact Person Name
- Stela Vujosevic
- Contact Person Email
- stela.vujosevic@unimi.it
Spain
- Earliest CTIS Part Ii Submission Date
- 28-05-2025
- Latest Decision Or Authorization Date
- 04-06-2025
- Processing Time Days
- 7
- Number Of Sites
- 6
- Number Of Participants
- 22
Sites
- Site Name
- Oftalmologia Vistahermosa S.L.
- Department Name
- Ophthalmology
- Principal Investigator Name
- Rosa Dolz Marco
- Principal Investigator Email
- rosadolzmarco@gmail.com
- Contact Person Name
- Rosa Dolz Marco
- Contact Person Email
- rosadolzmarco@gmail.com
- Site Name
- Hospital Universitario Puerta De Hierro De Majadahonda
- Department Name
- Ophthalmology
- Principal Investigator Name
- Jose Maria Ruiz Moreno
- Principal Investigator Email
- josemaria.ruiz@uclm.es
- Contact Person Name
- Jose Maria Ruiz Moreno
- Contact Person Email
- josemaria.ruiz@uclm.es
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Ophthalmology
- Principal Investigator Name
- Maria Socorro Alforja Castiella
- Principal Investigator Email
- ALFORJA@clinic.cat
- Contact Person Name
- Maria Socorro Alforja Castiella
- Contact Person Email
- ALFORJA@clinic.cat
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- Ophthalmology
- Principal Investigator Name
- Andres Romero Martinez
- Principal Investigator Email
- romeroverte@gmail.com
- Contact Person Name
- Andres Romero Martinez
- Contact Person Email
- romeroverte@gmail.com
- Site Name
- Clinica Baviera S.A.
- Department Name
- Ophthalmology
- Principal Investigator Name
- Marta Sanchez Figueroa
- Principal Investigator Email
- figueroa.marta@outlook.es
- Contact Person Name
- Marta Sanchez Figueroa
- Contact Person Email
- figueroa.marta@outlook.es
- Site Name
- Hospital Universitari General De Catalunya
- Department Name
- Ophthalmology
- Principal Investigator Name
- Laura Sararols Ramsay
- Principal Investigator Email
- lsararols@omiq.es
- Contact Person Name
- Laura Sararols Ramsay
- Contact Person Email
- lsararols@omiq.es
Sponsor
Primary sponsor
- Full Name
- F. Hoffmann-La Roche AG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Contract research organisations
- Name
- IQVIA Limited
- Responsibilities
- Monitoring
- Name
- Drugdev Inc.
- Responsibilities
- Site portal
- Name
- Perceptive Informatics Inc.
- Responsibilities
- IxRS Provider
Third parties
- {"country":"United States","full_name":"Prime Realty Holdings LLC","duties_or_roles":"Patient Transportation","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Perceptive Informatics Inc.","duties_or_roles":"IxRS Provider","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Optymedge LLC","duties_or_roles":"Central Visual Acuity Provider","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United Kingdom","full_name":"Q2q Communications Limited","duties_or_roles":"Investigator Meeting","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Patient Reimbursement Provider","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Drugdev Inc.","duties_or_roles":"Site portal","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Monitoring","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Duke University","duties_or_roles":"Vendor Imaging","organisation_type":"Educational Institution"}
- {"country":"United Kingdom","full_name":"Ashfield Healthcare Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Vabysmo 120 mg/mL solution for injection
- Active Substance
- FARICIMAB
- Modality
- Bispecific antibody
- Routes Of Administration
- Intravitreal use
- Route
- Intravitreal
- Authorisation Status
- Authorised (marketing authorisation EU/1/22/1683/001)
- Maximum Dose
- 6 mg (maxDailyDoseAmount: 6 mg) as recorded in product entry
Related trials
Other published trials that may interest you.
- Aflibercept for Neovascular age-related macular degeneration
- Aflibercept for Neovascular age-related macular degeneration
- Aflibercept for Neovascular age-related macular degeneration
- ranibizumab for Neovascular age-related macular degeneration
- RANIBIZUMAB for Neovascular age-related macular degeneration