Clinical trial • Phase III • Ophthalmology
FARICIMAB for Myopic choroidal neovascularization
Phase III trial of FARICIMAB for Myopic choroidal neovascularization.
Overview
- Trial Therapeutic Area
- Ophthalmology
- Trial Disease
- Myopic choroidal neovascularization
- Trial Stage
- Phase III
- Drug Modality
- Bispecific antibody|Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 17-11-2023
- First CTIS Authorization Date
- 26-03-2024
Trial design
Randomised, faricimab (intravitreal injection; dose/schedule not specified in the application)|ranibizumab (lucentis) (intravitreal injection; dose/schedule not specified in the application; product: lucentis 10 mg/ml solution for injection, marketing authorisation eu/1/06/374/004)-controlled Phase III trial across 40 sites in France, Germany, Italy and others.
- Randomised
- Yes
- Comparator
- FARICIMAB (intravitreal injection; dose/schedule not specified in the application)|RANIBIZUMAB (Lucentis) (intravitreal injection; dose/schedule not specified in the application; product: Lucentis 10 mg/ml solution for injection, marketing authorisation EU/1/06/374/004)
- Target Sample Size
- 190
- Trial Duration For Participant
- 336
Eligibility
Recruits 190 adults.
Inclusion criteria
- {"criterion_text":"- 1. Overtly healthy as determined by medical evaluation that includes medical history, physical examination, and laboratory tests"}
- {"criterion_text":"- 2. Treatment-naïve choroidal neovascularization (CNV) secondary to myopia"}
- {"criterion_text":"- 3. Diagnosis of active myopic CNV in the study eye confirmed by ocular examination and CRC review"}
- {"criterion_text":"- 4. BCVA of 78 to 24 letters, inclusive (20/32 to 20/320 approximate Snellen equivalent), using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol and assessed at the initial testing distance of 4 meters (see the BCVA manual for additional details) on Day 1"}
- {"criterion_text":"- 5. Presence of at least 1 of the following lesion types (determined by CRC): Subfoveal (presence of abnormal neovasculature in the avascular central fovea) Juxtafoveal (presence of abnormal neovasculature not under the center of the fovea but ≤ 200 um from the center) with involvement of the central macular area Extrafoveal (presence of abnormal neovasculature > 200 um from the center of the fovea) with involvement of the central macular area Margin of the optic disc (presence of abnormal neovasculature at peripapillary area) with involvement of the central macular area"}
- {"criterion_text":"- 6. Sufficiently clear ocular media and adequate pupillary dilatation to allow acquisition of good quality retinal images to confirm diagnosis"}
Exclusion criteria
- {"criterion_text":"- 1. CNV due to causes other than pathologic myopia, such as neovascular age-related macular degeneration, ocular histoplasmosis, trauma, angioid streaks, choroidal rupture, or uveitis, etc"}
- {"criterion_text":"- 2. Any history of macular pathology unrelated to pathologic myopia affecting vision or contributing to the presence of intraretinal or subretinal fluid"}
- {"criterion_text":"- 3. Presence at screening of central serous chorioretinopathy or myopic tractional maculopathy. Retinal pigment epithelial tear involving the macula on Day 1"}
- {"criterion_text":"- 4. Non-functioning non-study eye, defined as either: BCVA Snellen equivalent of 20/200 or worse No physical presence of non-study eye (i.e., monocular)"}
- {"criterion_text":"- 5. Prior IVT administration of faricimab in either eye"}
- {"criterion_text":"- 6. History of idiopathic or autoimmune-associated uveitis in either eye. Active ocular inflammation (anterior, intermediate or posterior uveitis, grade trace or above) or suspected or active ocular or periocular infection in either eye on Day 1"}
Endpoints
Primary endpoints
- {"endpoint_text":"- 1. Change from baseline in BCVA averaged over Weeks 4, 8, and 12","definition_or_measurement_approach":"BCVA measured using the ETDRS protocol at Weeks 4, 8 and 12; primary endpoint is change from baseline averaged over those weeks."}
Secondary endpoints
- {"endpoint_text":"- 1. Change from baseline in BCVA over time","definition_or_measurement_approach":"BCVA measured over study visits (ETDRS) to assess change from baseline over time."}
- {"endpoint_text":"- 2. Proportion of patients gaining ≥15 letters averaged over Weeks 4, 8, and 12","definition_or_measurement_approach":"Proportion based on ETDRS letter gain averaged across Weeks 4, 8 and 12."}
- {"endpoint_text":"- 3. Proportion of patients gaining ≥15 letters in BCVA from baseline over time","definition_or_measurement_approach":"Proportion of subjects achieving ≥15-letter BCVA gain at scheduled timepoints."}
- {"endpoint_text":"- 4. Proportion of patients avoiding loss of ≥15 letters in BCVA from baseline over time","definition_or_measurement_approach":"Proportion of subjects not losing ≥15 ETDRS letters at scheduled timepoints."}
- {"endpoint_text":"- 5. Proportion of patients gaining ≥15 letters or achieving BCVA of ≥84 letters over time","definition_or_measurement_approach":"Composite endpoint using ETDRS letter thresholds over time."}
- {"endpoint_text":"- 6. Proportion of patients with BCVA Snellen equivalent of 20/40 or better over time","definition_or_measurement_approach":"Proportion determined from ETDRS-to-Snellen-equivalent conversions at visits."}
- {"endpoint_text":"- 7. Proportion of patients with BCVA Snellen equivalent of 20/200 or worse over time","definition_or_measurement_approach":"Proportion determined from ETDRS-to-Snellen-equivalent conversions at visits."}
- {"endpoint_text":"- 8. Proportion of patients only receiving one injection from baseline to Week 12","definition_or_measurement_approach":"Count of IVT injections administered up to Week 12; proportion with only one injection."}
- {"endpoint_text":"- 9. Proportion of patients only receiving one injection from baseline to Week 24","definition_or_measurement_approach":"Count of IVT injections administered up to Week 24; proportion with only one injection."}
- {"endpoint_text":"- 10. Proportion of patients only receiving one injection from baseline to Week 48","definition_or_measurement_approach":"Count of IVT injections administered up to Week 48; proportion with only one injection."}
- {"endpoint_text":"- 11. Number of IVT injections received by Week 12","definition_or_measurement_approach":"Total number of intravitreal injections received by each patient by Week 12."}
- {"endpoint_text":"- 12. Number of IVT injections received by Week 24","definition_or_measurement_approach":"Total number of intravitreal injections received by each patient by Week 24."}
- {"endpoint_text":"- 13. Number of IVT injections received by Week 48","definition_or_measurement_approach":"Total number of intravitreal injections received by each patient by Week 48."}
- {"endpoint_text":"- 14. Change from baseline in central subfield thickness (CST) of the study eye averaged over Weeks 4, 8, and 12","definition_or_measurement_approach":"CST measured by OCT; change from baseline averaged over Weeks 4, 8 and 12."}
- {"endpoint_text":"- 15. Change from baseline in CST of the study eye over time","definition_or_measurement_approach":"CST measured by OCT over scheduled visits to assess change from baseline."}
- {"endpoint_text":"- 16. Change from baseline in total area of CNV lesion at Week 12 and Week 48","definition_or_measurement_approach":"Total lesion area measured (imaging assessment) at Weeks 12 and 48 compared to baseline."}
- {"endpoint_text":"- 17. Change from baseline in total area of CNV leakage at Week 12 and Week 48","definition_or_measurement_approach":"Total leakage area measured (imaging/FFA) at Weeks 12 and 48 compared to baseline."}
- {"endpoint_text":"- 18. Proportion of patients with absence of macular leakage at Week 12 and Week 48","definition_or_measurement_approach":"Determined by imaging (FFA/CFP/OCT) at Weeks 12 and 48."}
- {"endpoint_text":"- 19. Incidence and severity of ocular adverse events","definition_or_measurement_approach":"Standard AE reporting and grading for ocular adverse events."}
- {"endpoint_text":"- 20. Incidence and severity of non-ocular adverse events","definition_or_measurement_approach":"Standard AE reporting and grading for non-ocular adverse events."}
- {"endpoint_text":"- 21. Prevalence of ADAs at baseline and incidence of ADA during the study","definition_or_measurement_approach":"Antidrug antibodies measured at baseline and during study visits using immunogenicity assays."}
- {"endpoint_text":"- 22. Relationship between ADA status and efficacy or safety endpoints","definition_or_measurement_approach":"Exploratory analyses correlating ADA presence/status with efficacy (e.g., BCVA) and safety outcomes."}
Recruitment
- Planned Sample Size
- 190
- Recruitment Window Months
- 34
- Consent Approach
- Subject information sheets and informed consent forms are provided (documents listed: L1_SIS and ICF-Volunteer; L1_SIS and ICF-IAF; L1_SIS and ICF-Main; L1_SIS and ICF Infant Authorization). Multiple language materials/synopses are present (English, French, Spanish, Polish, Italian). Specific consent/assent text and age-specific consent handling are not extractable from the provided data.
Geography
- Total Number Of Sites
- 40
- Total Number Of Participants
- 90
France
- Earliest CTIS Part Ii Submission Date
- 15-02-2024
- Latest Decision Or Authorization Date
- 21-10-2025
- Processing Time Days
- 614
- Number Of Sites
- 11
- Number Of Participants
- 27
Sites
- Site Name
- Pole Vision Val D'Ouest
- Department Name
- Ophtalmology
- Contact Person Name
- Pierre-Loïc Cornut
- Contact Person Email
- direction@polevision.fr
- Site Name
- Centre Monticelli Paradis D Ophtalmologie
- Department Name
- Ophtalmology
- Contact Person Name
- Frederic Matonti
- Contact Person Email
- fdbm.retine@gmail.com
- Site Name
- Quinze-Vingts National Ophthalmology Hospital
- Department Name
- Ophtalmology
- Contact Person Name
- Jean-François Girmens
- Contact Person Email
- jfgirmens@15-20.fr
- Site Name
- Hospital Hotel Dieu
- Department Name
- Ophtalmology
- Contact Person Name
- Hélène Massé
- Contact Person Email
- catherine.ivan@chu-nantes.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Ophtalmology
- Contact Person Name
- Aude Couturier
- Contact Person Email
- anfel.lemiti@aphp.fr
- Site Name
- Theorie Etudes Organisation Recherche En Retine Medicale S.A.R.L.
- Department Name
- Ophtalmology
- Contact Person Name
- Salomon Yves Cohen
- Contact Person Email
- b.maloberti@gmail.com
- Site Name
- Ophtalmologie Maison Rouge S.C.M.
- Department Name
- Ophtalmology
- Contact Person Name
- Benjamin Wolff
- Contact Person Email
- v.vasseur@comr.fr
- Site Name
- Centre Hospitalier Intercommunal Creteil
- Department Name
- Ophtalmology
- Contact Person Name
- Eric Souied
- Contact Person Email
- eva.guetta@chicreteil.fr
- Site Name
- Hopital Fondation Adolphe De Rothschild
- Department Name
- Ophtalmology
- Contact Person Name
- Sophie Bonnin
- Contact Person Email
- sbonnin@for.paris
- Site Name
- Hopital De La Croix Rousse
- Department Name
- Ophtalmology
- Contact Person Name
- Laurent Kodjikian
- Contact Person Email
- amelie.bouilloux@chu-lyon.fr
- Site Name
- Retina
- Department Name
- Ophtalmology
- Contact Person Name
- Hessam Razavi
- Contact Person Email
- centrestexupery37@gmail.com
Germany
- Earliest CTIS Part Ii Submission Date
- 26-02-2024
- Latest Decision Or Authorization Date
- 31-07-2024
- Processing Time Days
- 156
- Number Of Sites
- 6
- Number Of Participants
- 10
Sites
- Site Name
- Universitaetsmedizin Goettingen
- Department Name
- Klinik für Augenheilkunde
- Contact Person Name
- Sebastian Bemme
- Contact Person Email
- sebastian.bemme@med.uni-goettingen.de
- Site Name
- University Hospital Cologne AöR
- Department Name
- Augenklinik
- Contact Person Name
- Tim Krohne
- Contact Person Email
- tim.krohne@uk-koeln.de
- Site Name
- Medical Center - University Of Freiburg
- Department Name
- Klinik für Augenheilkunde
- Contact Person Name
- Hansjürgen Agostini
- Contact Person Email
- hansjuergen.agostini@uniklinik-freiburg.de
- Site Name
- Universitaet Muenster
- Department Name
- Augenheilkunde
- Contact Person Name
- Nicole Eter
- Contact Person Email
- Direktorin.Augenklinik@ukmuenster.de
- Site Name
- Klinikum rechts der Isar der TU Muenchen AöR
- Department Name
- Augenklinik
- Contact Person Name
- Mathias Maier
- Contact Person Email
- mathias.maier@mri.tum.de
- Site Name
- Knappschaftsklinikum Saar GmbH
- Department Name
- Augenklinik Sulzbach
- Contact Person Name
- Boris Stanzel
- Contact Person Email
- boris.stanzel@kksaar.de
Italy
- Earliest CTIS Part Ii Submission Date
- 01-12-2023
- Latest Decision Or Authorization Date
- 01-08-2024
- Processing Time Days
- 244
- Number Of Sites
- 6
- Number Of Participants
- 18
Sites
- Site Name
- Fondazione G.B.Bietti Per Lo Studio E La Ricerca In Oftalmologia
- Department Name
- UOC Oculistica Fondazione G.B.Bietti-IRCCS presso Ospedale Britannico
- Contact Person Name
- Mariacristina Parravano
- Contact Person Email
- mariacristina.parravano@fondazionebietti.it
- Site Name
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
- Department Name
- SSD Oftalmologia
- Contact Person Name
- Francesco Viola
- Contact Person Email
- francesco.viola@unimi.it
- Site Name
- Universita' Degli Studi G. D'annunzio Di Chieti
- Department Name
- UOC Riabilitazione Visiva Chirurgica
- Contact Person Name
- Rodolfo Mastropasqua
- Contact Person Email
- rodolfo.mastropasqua@unich.it
- Site Name
- Azienda Sanitaria Universitaria Friuli Centrale
- Department Name
- Oftalmologia
- Contact Person Name
- Paolo Lanzetta
- Contact Person Email
- paolo.lanzetta@uniud.it
- Site Name
- University Hospital Consorziale Policlinico
- Department Name
- UO Oftalmologia Universitaria
- Contact Person Name
- Francesco Boscia
- Contact Person Email
- oftalmologiauniv@policlinico.ba.it
- Site Name
- Azienda Ospedaliera Dei Colli
- Department Name
- Oftalmologia
- Contact Person Name
- Flavia Chiosi
- Contact Person Email
- flavia.chiosi@ospedalideicolli.it
Poland
- Earliest CTIS Part Ii Submission Date
- 22-02-2024
- Latest Decision Or Authorization Date
- 04-08-2024
- Processing Time Days
- 164
- Number Of Sites
- 11
- Number Of Participants
- 19
Sites
- Site Name
- Pryzmat Sp. z o.o.
- Department Name
- not applicable
- Contact Person Name
- Karolina Żaczek-Zakrzewska
- Contact Person Email
- biuro@pryzmat-okulistyka.pl
- Site Name
- Gabinet Okulistyczny Prof Edward Wylegala
- Department Name
- not applicable
- Contact Person Name
- Adam Wylęgała
- Contact Person Email
- cmwylegala@gmail.com
- Site Name
- Lensclinic Sp. z o.o.
- Department Name
- not applicable
- Contact Person Name
- Katarzyna Michalska-Małecka
- Contact Person Email
- biuro@lensclinic.pl
- Site Name
- Lensclinic Sp. z o.o.
- Department Name
- not applicable
- Contact Person Name
- Katarzyna Michalska-Małecka
- Contact Person Email
- biuro@lensclinic.pl
- Site Name
- Gabinet Okulistyczny Jerzy Mackiewicz
- Department Name
- not applicable
- Contact Person Name
- Jerzy Mackiewicz
- Contact Person Email
- badania@mackiewicz-okulistyka.pl
- Site Name
- Oftalmika Sp. z o.o.
- Department Name
- not applicable
- Contact Person Name
- Jakub Kałużny
- Contact Person Email
- magda.d.marzec@oftalmika.pl
- Site Name
- Pryzmat Sp. z o.o.
- Department Name
- not applicable
- Contact Person Name
- Karolina Żaczek-Zakrzewska
- Contact Person Email
- biuro@pryzmat-okulistyka.pl
- Site Name
- Centrum Diagnostyki I Mikrochirurgii Oka Lens Sp. z o.o.
- Department Name
- not applicable
- Contact Person Name
- Dominik Zalewski
- Contact Person Email
- badaniaklinicznelens@gmail.com
- Site Name
- Klinika Okulistyczna Jasne Blonia Sp. z o.o.
- Department Name
- not applicable
- Contact Person Name
- Zofia Nawrocka
- Contact Person Email
- jasneblonia@interia.pl
- Site Name
- Reoptis Sp. z o.o.
- Department Name
- not applicable
- Contact Person Name
- Andrzej Dmitriew
- Contact Person Email
- malwina.czekalska@reoptis.pl
- Site Name
- Centrum Medyczne Dietla 19 Sp. z o.o.
- Department Name
- not applicable
- Contact Person Name
- Piotr Oleksy
- Contact Person Email
- rejestracja@dietla19.pl
Spain
- Earliest CTIS Part Ii Submission Date
- 01-12-2023
- Latest Decision Or Authorization Date
- 09-02-2026
- Processing Time Days
- 801
- Number Of Sites
- 6
- Number Of Participants
- 16
Sites
- Site Name
- Clinica Universidad De Navarra
- Department Name
- Ophtalmology
- Contact Person Name
- Alfredo García Layana
- Contact Person Email
- aglayana@unav.es
- Site Name
- Clinica De Oftalmologia De Cordoba S.L.
- Department Name
- Ophtalmology
- Contact Person Name
- Juan Manuel Cubero Parra
- Contact Person Email
- jmcubero@hospitalarruzafa.com
- Site Name
- Bellvitge University Hospital
- Department Name
- Ophtalmology
- Contact Person Name
- Luis Arias Barquet
- Contact Person Email
- luisariasbarquet@gmail.com
- Site Name
- Oftalmologia Vistahermosa S.L.
- Department Name
- Ophtalmology
- Contact Person Name
- Roberto Gallego Pinazo
- Contact Person Email
- robertogallegopinazo@gmail.com
- Site Name
- Complexo Hospitalario Universitario De Santiago
- Department Name
- Medical Retina and Ocular Diabetes Unit
- Contact Person Name
- Maximino Abraldes López-Veiga
- Contact Person Email
- maxiabraldes@gmail.com
- Site Name
- Hospital Universitario Puerta De Hierro De Majadahonda
- Department Name
- Ophthalmology
- Contact Person Name
- José María Ruiz Moreno
- Contact Person Email
- josemaria.ruiz@uclm.es
Sponsor
Primary sponsor
- Full Name
- F. Hoffmann-La Roche AG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Contract research organisations
- Name
- Drugdev Inc.
- Responsibilities
- Global CRO
Third parties
- {"country":"United States","full_name":"Optymedge LLC","duties_or_roles":"Other Third Party Duty","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"1","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"6","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Other Third Party Duty","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Germany","full_name":"Steinbeis Forschungszentrum Grade Reading Center","duties_or_roles":"Other Third Party Duty","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services S.a.r.l.","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Drugdev Inc.","duties_or_roles":"Global CRO","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- FARICIMAB
- Active Substance
- FARICIMAB
- Modality
- Bispecific antibody
- Routes Of Administration
- Intravitreal
- Route
- Intravitreal
- Authorisation Status
- Not authorised/Investigational (no marketing authorisation number provided)
- Maximum Dose
- 0.5 mg (max daily as per product entry); max total amount listed 6 mg
- Investigational Product Name
- Lucentis 10 mg/ml solution for injection
- Active Substance
- RANIBIZUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- Intravitreal
- Route
- Intravitreal
- Authorisation Status
- Marketing authorisation: EU/1/06/374/004
- Maximum Dose
- 6 mg (max daily amount as listed in product entry)
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