Clinical trial • Phase III • Ophthalmology
SURABGENE LOMPARVOVEC for Neovascular age-related macular degeneration
Phase III trial of SURABGENE LOMPARVOVEC for Neovascular age-related macular degeneration.
Overview
- Trial Therapeutic Area
- Ophthalmology
- Trial Disease
- Neovascular age-related macular degeneration
- Trial Stage
- Phase III
- Drug Modality
- Gene therapy | Peptide/protein/enzyme | Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 04-10-2023
- First CTIS Authorization Date
- 15-02-2024
Trial design
Randomised, aflibercept (eylea 40 mg/ml solution for injection in pre-filled syringe) — comparator specified; dosing schedule not specified in the provided record.-controlled Phase III trial in France, Germany, Italy and others.
- Randomised
- Yes
- Comparator
- Aflibercept (Eylea 40 mg/mL solution for injection in pre-filled syringe) — comparator specified; dosing schedule not specified in the provided record.
- Target Sample Size
- 444
- Trial Duration For Participant
- 378
Eligibility
Recruits 444 Participants must be willing and able to provide written, signed informed consent and must not be incarcerated. The protocol explicitly excludes "adults under legal protection measure [eg, under guardianship/curatorship] and adults unable to express their consent" from participation. No paediatric or other vulnerable populations were selected in the trial population settings..
- Vulnerable Population
- Participants must be willing and able to provide written, signed informed consent and must not be incarcerated. The protocol explicitly excludes "adults under legal protection measure [eg, under guardianship/curatorship] and adults unable to express their consent" from participation. No paediatric or other vulnerable populations were selected in the trial population settings.
Inclusion criteria
- {"criterion_text":"- 1-Age ≥ 50 years and ≤ 89 years\n- 2-An ETDRS BCVA letter score between ≤ 78 and ≥ 40 in the study eye\n- 3-Diagnosis of CNV secondary to AMD in the study eye. Since nAMD diagnosis, must have received a minimum of 1 anti-VEGF injection in the study eye prior to Screening Visit 1 and been responsive.\n- 4-Must be pseudophakic (at least 12 weeks postcataract surgery) in the study eye.\n- 5-Willing and able to provide written, signed informed consent for this study and must not be incarcerated. (Note: adults under legal protection measure [eg, under guardianship/curatorship] and adults unable to express their consent are not able to participate). Investigator's discretion should be applied.\n- 6-Participants must have demonstrated a meaningful response to anti-VEGF therapy at study entry"}
Exclusion criteria
- {"criterion_text":"- 1-CNV or macular edema in the study eye secondary to any causes other than AMD\n- 10-Prior treatment with gene therapy\n- 2-Subfoveal fibrosis or atrophy in the study eye\n- 3-Any condition in the investigator's opinion that could limit VA improvement in the study eye\n- 4-Active or history of retinal detachment or current retinal tear in the study eye\n- 5-Advanced glaucoma or history of secondary glaucoma in the study eye\n- 6-Myocardial infarction, cerebrovascular accident, or transient ischemic attach within the past 6 months\n- 7-Other clinically significant, active systemic or localized infections at any screening visit that may compromise the participant's safety or interpretation of results such as: mycobacterial, fungal, or viral infections (eg, HIV, hepatitis B or C, SARS-CoV-2 2019 [COVID-19], Epstein-Barr virus, syphilis, HSV, varicella-zoster virus, CMV).\n- 8-History of intraocular surgery in the study eye within 12 weeks prior to Screening Visit 1\n- 9-History of intravitreal therapy in the study eye, such as intravitreal steroid injection or investigational product, other than anti-VEGF therapy, in the 6 months prior to Screening Visit 1."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Mean change from baseline in BCVA to Week 54 based on the ETDRS score (noninferiority to the active control).","definition_or_measurement_approach":"Change from baseline in best-corrected visual acuity (BCVA) measured by ETDRS letter score at Week 54; analysis assesses noninferiority to the active control."}
Secondary endpoints
- {"endpoint_text":"- Proportion of participants with ≤2 supplemental anti-VEGF injections through Week 54 (ABBV-RGX-314 randomized participants)","definition_or_measurement_approach":"Proportion of randomized ABBV-RGX-314 participants receiving ≤2 supplemental anti-VEGF injections through Week 54."}
- {"endpoint_text":"- Proportion of participants with no supplemental anti-VEGF injections through Week 54 (ABBV-RGX-314 randomized participants)","definition_or_measurement_approach":"Proportion of randomized ABBV-RGX-314 participants receiving zero supplemental anti-VEGF injections through Week 54."}
- {"endpoint_text":"- Percent reduction in anti-VEGF injection annualized rate through Week 54 compared with the prior yeara (ABBV-RGX-314 randomized participants)","definition_or_measurement_approach":"Percent reduction in the annualized rate of anti-VEGF injections through Week 54 compared with the prior year for randomized ABBV-RGX-314 participants."}
- {"endpoint_text":"- Mean change from baseline in BCVA to Week 54 based on the ETDRS score (superiority to the active control)","definition_or_measurement_approach":"Change from baseline in BCVA (ETDRS) at Week 54 evaluated for superiority comparison against the active control."}
Recruitment
- Planned Sample Size
- 444
- Recruitment Window Months
- 33
- Consent Approach
- Participants must provide written, signed informed consent; adults under legal protection (eg, under guardianship/curatorship) and adults unable to express consent are not eligible. Country-specific ICF and participant information documents are provided (country-specific ICFs listed for France, Germany, Italy, Hungary, Spain and other public-language documents), and there are specific ICF documents addressing pregnant partners and data protection. No assent procedures for minors are provided because eligibility requires adult ages (≥50 to ≤89).
Geography
- Total Number Of Sites
- 41
- Total Number Of Participants
- 216
France
- Earliest CTIS Part Ii Submission Date
- 16-01-2024
- Latest Decision Or Authorization Date
- 17-04-2024
- Processing Time Days
- 92
- Number Of Sites
- 11
- Number Of Participants
- 84
Sites
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Service Ophtalmologie
- Contact Person Name
- Aude Couturier
- Contact Person Email
- aude.couturier@aphp.fr
- Site Name
- Clinique Juge
- Department Name
- Ophtalmologie
- Contact Person Name
- François Devin
- Contact Person Email
- fdbm.retine@gmail.com
- Site Name
- Centre Hospitalier Intercommunal Creteil
- Department Name
- Service Ophtalmologie
- Contact Person Name
- Eric Souied
- Contact Person Email
- eric.souied@chicreteil.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Ophtalmologie
- Contact Person Name
- Francine BEHAR-COHEN
- Contact Person Email
- francine.behar@gmail.com
- Site Name
- Centre Hospitalier Universitaire De Nice
- Department Name
- Ophthalmology
- Contact Person Name
- Stéphanie Baillif-Gostoli
- Contact Person Email
- baillif.s@chu-nice.fr
- Site Name
- Hospital Hotel Dieu
- Department Name
- Ophtalmologie
- Contact Person Name
- Olivier Lebreton
- Contact Person Email
- olivier.lebreton@chu-nantes.fr
- Site Name
- Centre Hospitalier Universitaire De Toulouse
- Department Name
- Service d'ophtalmologie
- Contact Person Name
- Vincent SOLER
- Contact Person Email
- soler.v@chu-toulouse.fr
- Site Name
- Hopital De La Croix Rousse
- Department Name
- Ophtalmologie
- Contact Person Name
- Laurent Kodjikian
- Contact Person Email
- laurent.kodjikian@chu-lyon.fr
- Site Name
- Centre Hospitalier Universitaire De Dijon
- Department Name
- Service d’Ophtalmologie
- Contact Person Name
- Catherine Creuzot-Garcher
- Contact Person Email
- catherine.creuzot-garcher@chu-dijon.fr
- Site Name
- Clinique Honore Cave
- Department Name
- Ophtalmologie
- Contact Person Name
- Vincent GUALINO
- Contact Person Email
- vincent.gualino@gmail.com
- Site Name
- Centre Monticelli Paradis D Ophtalmologie
- Department Name
- Ophtalmologie
- Contact Person Name
- François Devin
- Contact Person Email
- fdbm.retine@gmail.com
Germany
- Earliest CTIS Part Ii Submission Date
- 08-01-2024
- Latest Decision Or Authorization Date
- 20-02-2024
- Processing Time Days
- 43
- Number Of Sites
- 7
- Number Of Participants
- 37
Sites
- Site Name
- University Medical Center Hamburg-Eppendorf
- Department Name
- Augenheilkunde
- Contact Person Name
- Martin Spitzer
- Contact Person Email
- m.spitzer@uke.de
- Site Name
- Universitaetsklinikum Bonn AöR
- Department Name
- Augenklinik
- Contact Person Name
- Kristina Pfau
- Contact Person Email
- Kristina.Pfau@ukbonn.de
- Site Name
- Medical Center - University Of Freiburg
- Department Name
- Augenklinik
- Contact Person Name
- Hansjuergen Agostini
- Contact Person Email
- hansjuergen.agostini@uniklinik-freiburg.de
- Site Name
- Universitaetsklinikum Ulm AöR
- Department Name
- Augenklinik
- Contact Person Name
- Armin Wolf
- Contact Person Email
- Armin.Wolf@uniklinik-ulm.de
- Site Name
- Knappschaftsklinikum Saar GmbH
- Department Name
- Augenklinik Sulzbach
- Contact Person Name
- Boris Stanzel
- Contact Person Email
- boris.stanzel@kksaar.de
- Site Name
- Klinikum der Stadt Ludwigshafen am Rhein gGmbH
- Department Name
- Augenklinik
- Contact Person Name
- Lars-Olof Hattenbach
- Contact Person Email
- hattenbl@klilu.de
- Site Name
- Universitaetsklinikum Muenster AöR
- Department Name
- Department Ophthalmology
- Contact Person Name
- Nicole Eter
- Contact Person Email
- nicole.eter@ukmuenster.de
Italy
- Earliest CTIS Part Ii Submission Date
- 07-09-2023
- Latest Decision Or Authorization Date
- 20-02-2024
- Processing Time Days
- 166
- Number Of Sites
- 10
- Number Of Participants
- 45
Sites
- Site Name
- Azienda Sanitaria Locale 2 Lanciano Vasto Chieti
- Department Name
- UOC di Riabilitazione Visiva Chirurgica
- Contact Person Name
- Rodolfo Mastropasqua
- Contact Person Email
- rodolfo.mastropasqua@unich.it
- Site Name
- Azienda Sanitaria Universitaria Friuli Centrale
- Department Name
- Clinica Oculistica
- Contact Person Name
- Paolo Lanzetta
- Contact Person Email
- paolo.lanzetta@uniud.it
- Site Name
- University Hospital Of Ferrara
- Department Name
- Clinica Oculistica
- Contact Person Name
- Marco Mura
- Contact Person Email
- marco.mura@ospfe.it
- Site Name
- Fondazione G.B.Bietti Per Lo Studio E La Ricerca In Oftalmologia
- Department Name
- Oftalmologia
- Contact Person Name
- Tommaso Rossi
- Contact Person Email
- tommaso.rossi@fondazionebietti.it
- Site Name
- IRCCS Ospedale Sacro Cuore Don Calabria
- Department Name
- Oculistica
- Contact Person Name
- Grazia Pertile
- Contact Person Email
- grazia.pertile@gmail.com
- Site Name
- ASST Fatebenefratelli Sacco
- Department Name
- U.O. Clinica Oculistica
- Contact Person Name
- Matteo Cereda
- Contact Person Email
- matteo.cereda@unimi.it
- Site Name
- University Hospital Consorziale Policlinico
- Department Name
- UOC Oftalmologia Universitaria
- Contact Person Name
- Francesco Boscia
- Contact Person Email
- francescoboscia@hotmail.com
- Site Name
- Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
- Department Name
- UOC Clinica Oculistica
- Contact Person Name
- Michele Della Corte
- Contact Person Email
- michele.dellacorte@unicampania.it
- Site Name
- Ospedale San Raffaele S.r.l.
- Department Name
- UOC di Oculistica
- Contact Person Name
- Francesco Bandello
- Contact Person Email
- bandello.francesco@hsr.it
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- UOC Oculistica
- Contact Person Name
- Angelo Maria Minnella
- Contact Person Email
- AngeloMaria.Minnella@unicatt.it
Hungary
- Earliest CTIS Part Ii Submission Date
- 29-01-2024
- Latest Decision Or Authorization Date
- 19-02-2024
- Processing Time Days
- 21
- Number Of Sites
- 3
- Number Of Participants
- 20
Sites
- Site Name
- Nozologen Kft.
- Department Name
- 353
- Contact Person Name
- Balázs Varsányi
- Contact Person Email
- varsanyi.balazs@ganglion.hu
- Site Name
- Budapest Retina Associates Kft.
- Department Name
- 352
- Contact Person Name
- András Seres
- Contact Person Email
- seres@budapestretina.hu
- Site Name
- University Of Debrecen
- Department Name
- 351: Szemklinika
- Contact Person Name
- Attila Vajas
- Contact Person Email
- vajasa@gmail.com
Spain
- Earliest CTIS Part Ii Submission Date
- 07-09-2023
- Latest Decision Or Authorization Date
- 05-03-2024
- Processing Time Days
- 180
- Number Of Sites
- 10
- Number Of Participants
- 30
Sites
- Site Name
- Hospital Universitario Puerta De Hierro De Majadahonda
- Department Name
- Oftalmología
- Contact Person Name
- Jose María Ruiz Moreno
- Contact Person Email
- josemaria.ruiz@uclm.es
- Site Name
- Complejo Hospitalario Universitario Insular Materno Infantil
- Department Name
- Oftalmología
- Contact Person Name
- Francisco Antonio Cabrera López
- Contact Person Email
- fcablop@gobiernodecanarias.org
- Site Name
- Bellvitge University Hospital
- Department Name
- Oftalmología
- Contact Person Name
- Luis Arias Barquet
- Contact Person Email
- larias@bellvitgehospital.cat
- Site Name
- Clinica De Oftalmologia De Cordoba S.L.
- Department Name
- Oftalmología
- Contact Person Name
- Juan Manuel Cubero Parra
- Contact Person Email
- info@hospitalarruzafa.com
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Oftalmología
- Contact Person Name
- Luis Francisco Moreno García
- Contact Person Email
- luisfco.moreno@salud.madrid.org
- Site Name
- Clinica Baviera S.A.
- Department Name
- Oftalmología
- Contact Person Name
- Marta Suarez de Figueroa Díaz
- Contact Person Email
- Figueroa.Marta@outlook.es
- Site Name
- Hospital Provincial De Conxo
- Department Name
- Oftalmología
- Contact Person Name
- Maximino José Abraldes
- Contact Person Email
- maximino.abraldes.lopez-veiga@sergas.es
- Site Name
- Hospital De La Santa Creu I Sant Pau
- Department Name
- Oftalmología
- Contact Person Name
- José Ignacio Vela Segarra
- Contact Person Email
- ivela@santpau.cat
- Site Name
- Instituto De Microcirugia Ocular Dos S.L.
- Department Name
- Oftalmología
- Contact Person Name
- Rafael Navarro Alemany
- Contact Person Email
- navarro@imo.es
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Oftalmología
- Contact Person Name
- Joan Giralt
- Contact Person Email
- JGIRALT@clinic.cat
Sponsor
Primary sponsor
- Full Name
- Abbvie Deutschland GmbH & Co. KG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Germany
Contract research organisations
- Name
- Parexel International (IRL) Limited
- Responsibilities
- sponsorDuties codes: 1, 2, 5
- Name
- 4g Clinical LLC
- Responsibilities
- sponsorDuties codes: 3
- Name
- Merit CRO Inc.
- Responsibilities
- Imaging Center
- Name
- Medidata Solutions Inc.
- Responsibilities
- sponsorDuties codes: 6, 7
- Name
- Labcorp Central Laboratory Services S.a.r.l.
- Responsibilities
- Laboratory services (sponsorDuties code: 4)
- Name
- Statistics & Data Corp.
- Responsibilities
- sponsorDuties code: 10
Third parties
- {"country":"United States","full_name":"4g Clinical LLC","duties_or_roles":"sponsorDuties codes: 3","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Merit CRO Inc.","duties_or_roles":"Imaging Center","organisation_type":"Pharmaceutical company"}
- {"country":"Canada","full_name":"Axiom Real-Time Metrics Inc.","duties_or_roles":"PRO vendor","organisation_type":"Pharmaceutical company"}
- {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services S.a.r.l.","duties_or_roles":"Laboratory services (sponsorDuties code: 4)","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Pci Pharma Services","duties_or_roles":"Contract Packaging Organization","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties codes: 6, 7","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Statistics & Data Corp.","duties_or_roles":"Biostatistics / data (sponsorDuties code: 10)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Elligo Health Research Inc.","duties_or_roles":"Patient transportation","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Arup Laboratories Inc.","duties_or_roles":"Laboratory services (sponsorDuties code: 4)","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Optymedge LLC","duties_or_roles":"Visual acuity examiner and lane certification","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"sponsorDuties codes: 1, 2, 5","organisation_type":"Pharmaceutical company"}
- {"country":"France","full_name":"Biofortis","duties_or_roles":"Laboratory services (sponsorDuties code: 4)","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Surabgene Lomparvovec (ABBV-RGX-314)
- Active Substance
- SURABGENE LOMPARVOVEC
- Modality
- Gene therapy
- Routes Of Administration
- SUBRETINAL USE
- Route
- Subretinal
- Authorisation Status
- Investigational (prodAuthStatus: 1)
- Investigational Product Name
- Lucentis 10 mg/ml solution for injection in pre-filled syringe
- Active Substance
- RANIBIZUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVITREAL USE
- Route
- Intravitreal
- Authorisation Status
- Authorised (marketing authorisation present, prodAuthStatus: 2)
- Maximum Dose
- 0.5 mg
- Investigational Product Name
- Eylea 40 mg/mL solution for injection in pre-filled syringe
- Active Substance
- AFLIBERCEPT
- Modality
- Peptide/protein/enzyme (fusion protein)
- Routes Of Administration
- INTRAVITREAL USE
- Route
- Intravitreal
- Authorisation Status
- Authorised (marketing authorisation present, prodAuthStatus: 2)
- Maximum Dose
- 20 mg
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