Clinical trial • Phase II|Phase IV • Ophthalmology
SURABGENE LOMPARVOVEC for Neovascular age-related macular degeneration
Phase II|Phase IV trial of SURABGENE LOMPARVOVEC for Neovascular age-related macular degeneration. None/Not specified-controlled. 1301 participants.
Overview
- Trial Therapeutic Area
- Ophthalmology
- Trial Disease
- Neovascular age-related macular degeneration
- Trial Stage
- Phase II|Phase IV
- Drug Modality
- Gene therapy
Key dates
- Initial CTIS Submission Date
- 28-03-2025
- First CTIS Authorization Date
- 14-07-2025
Trial design
None/Not specified-controlled Phase II|Phase IV trial in France, Hungary, Italy and others.
- Comparator
- None/Not specified
- Target Sample Size
- 1301
- Trial Duration For Participant
- 1831
Eligibility
Recruits 1301 No vulnerable population selected; participants must be able and willing to provide written, signed informed consent for this study..
- Vulnerable Population
- No vulnerable population selected; participants must be able and willing to provide written, signed informed consent for this study.
Inclusion criteria
- {"criterion_text":"- Able and willing to provide written, signed informed consent for this study"}
- {"criterion_text":"- Previously enrolled in a clinical study of ABBV-RGX-314 subretinal administration for the treatment of nAMD and must have received treatment in that study"}
- {"criterion_text":"- Must be willing and able to comply with all study procedures"}
Exclusion criteria
- {"criterion_text":"- Not Applicable"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Incidence of ocular adverse events (AEs) and any serious adverse events (SAEs)","definition_or_measurement_approach":"Incidence (count/rate) of ocular AEs and any SAEs as reported in study follow-up (no further definition provided in source JSON)"}
Secondary endpoints
- {"endpoint_text":"- Incidence of non-ocular AEs and any adverse events of special interest (AESIs)","definition_or_measurement_approach":"Incidence (count/rate) of non-ocular AEs and AESIs as reported in study follow-up"}
- {"endpoint_text":"- Mean change from baseline (ie, prior to ABBV-RGX-314 administration in the parent study) in BCVA","definition_or_measurement_approach":"Mean change in BCVA from baseline (prior to ABBV-RGX-314 in parent study); BCVA measured (translations reference ETDRS scoring in related translation)"}
- {"endpoint_text":"- Proportion of participants losing letters in BCVA compared with baseline (ie, prior to ABBV-RGX 314 administration in the parent study) in the study eye at assessed timepoints","definition_or_measurement_approach":"Proportion losing ≥5, 10 and 15 letters in BCVA compared with baseline at assessed timepoints (BCVA/ETDRS)"}
- {"endpoint_text":"- Mean change from baseline (ie, prior to ABBV-RGX-314 administration in the parent study) in CRT as measured by SD-OCT in the study eye at assessed timepoints","definition_or_measurement_approach":"Mean change in central retinal thickness (CRT) measured by spectral domain optical coherence tomography (SD-OCT) from baseline"}
- {"endpoint_text":"- Mean supplemental anti-VEGF injection annualized rate through years 2, 3, 4, and 5 based on ongoing chart review in the study eye","definition_or_measurement_approach":"Annualized rate of supplemental anti-VEGF injections through years 2–5 based on ongoing chart review"}
- {"endpoint_text":"- Mean supplemental anti-VEGF injection annualized rate in years 2, 3, 4, and 5 based on ongoing chart review in the study eye","definition_or_measurement_approach":"Annualized rate of supplemental anti-VEGF injections in years 2–5 based on ongoing chart review"}
- {"endpoint_text":"- Mean number of supplemental anti-VEGF injections through years 2, 3, 4, and 5 based on ongoing chart review in the study eye","definition_or_measurement_approach":"Mean number of supplemental anti-VEGF injections through years 2–5 based on chart review"}
- {"endpoint_text":"- Mean number of supplemental anti-VEGF injections in years 2, 3, 4, and 5 based on ongoing chart review in the study eye","definition_or_measurement_approach":"Mean number of supplemental anti-VEGF injections in years 2–5 based on chart review"}
- {"endpoint_text":"- Mean number of retina specialist visits attended for nAMD through years 2, 3, 4, and 5 based on ongoing chart review","definition_or_measurement_approach":"Mean number of retina specialist visits for nAMD through years 2–5 based on chart review"}
- {"endpoint_text":"- Mean number of retina specialist visits attended for nAMD in years 2, 3, 4, and 5 based on ongoing chart review","definition_or_measurement_approach":"Mean number of retina specialist visits for nAMD in years 2–5 based on chart review"}
Recruitment
- Planned Sample Size
- 1301
- Recruitment Window Months
- 60
- Consent Approach
- Participants must be able and willing to provide written, signed informed consent for this study. Subject information and informed consent documents are provided (country-specific versions listed for FR, HU, IT, ES, DE). No assent/parental consent procedures listed (no paediatric population selected).
Geography
- Total Number Of Sites
- 39
- Total Number Of Participants
- 84
France
- Earliest CTIS Part Ii Submission Date
- 03-07-2025
- Latest Decision Or Authorization Date
- 16-07-2025
- Processing Time Days
- 13
- Number Of Sites
- 10
- Number Of Participants
- 19
Sites
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Ophtalmopole de Paris
- Contact Person Name
- Francine Behar-Cohen
- Contact Person Email
- Francine.behar@gmail.com
- Site Name
- Hospices Civils De Lyon
- Department Name
- Ophthalmology
- Contact Person Name
- Laurent Kodjikian
- Contact Person Email
- Laurent.kodjikian@chu-lyon.fr
- Site Name
- Centre Monticelli Paradis D Ophtalmologie
- Department Name
- Ophthalmology
- Contact Person Name
- Francois Devin
- Contact Person Email
- Fdbm.retine@gmail.com
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Ophthalmology
- Contact Person Name
- Aude Couturier
- Contact Person Email
- Aude.couturier@aphp.fr
- Site Name
- Centre Hospitalier Intercommunal Creteil
- Department Name
- Ophthalmology
- Contact Person Name
- Eric Souied
- Contact Person Email
- Eric.souied@chicreteil.fr
- Site Name
- Clinique Honore Cave
- Department Name
- Ophthalmology
- Contact Person Name
- Vincent Gualiano
- Contact Person Email
- Recherche-chc@hotmail.com
- Site Name
- Centre Hospitalier Universitaire De Nice
- Department Name
- Ophthalmology
- Contact Person Name
- Stephanie Baillif
- Contact Person Email
- Baillif.s@chu-nice.fr
- Site Name
- Centre Hospitalier Universitaire De Toulouse
- Department Name
- Ophthalmology Department
- Contact Person Name
- Vincent Soler
- Contact Person Email
- Soler.v@chu-toulouse.fr
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- Ophthalmology Department
- Contact Person Name
- Olivier Lebreton
- Contact Person Email
- Olivier.lebreton@chu-nantes.fr
- Site Name
- Centre Hospitalier Universitaire De Dijon
- Department Name
- Ophthalmology
- Contact Person Name
- Catherine Creuzot-Garcher
- Contact Person Email
- Catherine.creuzot-garcher@chu-dijon.fr
Hungary
- Earliest CTIS Part Ii Submission Date
- 15-05-2025
- Latest Decision Or Authorization Date
- 18-07-2025
- Processing Time Days
- 64
- Number Of Sites
- 3
- Number Of Participants
- 7
Sites
- Site Name
- Nozologen Kft.
- Contact Person Name
- Balazs Varsanyi
- Contact Person Email
- varsanyi.balazs@gmail.com
- Site Name
- Budapest Retina Associates Kft.
- Contact Person Name
- András Seres
- Contact Person Email
- seres@budapestretina.hu
- Site Name
- University Of Debrecen
- Contact Person Name
- Attila Vajas
- Contact Person Email
- vajasa@gmail.com
Italy
- Earliest CTIS Part Ii Submission Date
- 08-07-2025
- Latest Decision Or Authorization Date
- 06-02-2026
- Processing Time Days
- 213
- Number Of Sites
- 10
- Number Of Participants
- 24
Sites
- Site Name
- University Hospital Of Ferrara
- Department Name
- Unità Operativa di Clinica Oculistica
- Contact Person Name
- Marco Mura
- Contact Person Email
- mrumrc@unife.it
- Site Name
- Azienda Universitaria Ospedaliera Consorziale Policlinico Bari
- Department Name
- UO 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
- D.A.I. Medico-Chirurgico ad Alta Specialità — Clinica Oculistica
- Contact Person Name
- Michele Della Corte
- Contact Person Email
- michele.dellacorte@unicampania.it
- Site Name
- Azienda Sanitaria Universitaria Friuli Centrale
- Department Name
- SOC Clinica oculistica
- Contact Person Name
- Paolo Lanzetta
- Contact Person Email
- paolo.lanzetta@uniud.it
- Site Name
- Azienda Sanitaria Locale 2 Lanciano Vasto Chieti
- Department Name
- U.O.C. Riabilitazione Visiva Chirurgica
- Contact Person Name
- Rodolfo Mastropasqua
- Contact Person Email
- rodolfo.mastropasqua@unich.it
- Site Name
- ASST Fatebenefratelli Sacco
- Department Name
- Eye Clinic
- Contact Person Name
- Matteo Giuseppe Cereda
- Contact Person Email
- cereda.matteo@asst-fbf-sacco.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
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- UOC Oculistica
- Contact Person Name
- Angelo Maria Minnella
- Contact Person Email
- angelomaria.minnella@unicatt.it
- Site Name
- Ospedale San Raffaele S.r.l.
- Department Name
- Unità di Oculistica
- Contact Person Name
- Francesco Bandello
- Contact Person Email
- bandello.francesco@hsr.it
- Site Name
- Fondazione G.B.Bietti Per Lo Studio E La Ricerca In Oftalmologia
- Department Name
- UOC di Oftalmologia
- Contact Person Name
- Tommaso Rossi
- Contact Person Email
- tommaso.rossi@fondazionebietti.it
Spain
- Earliest CTIS Part Ii Submission Date
- 12-06-2025
- Latest Decision Or Authorization Date
- 16-07-2025
- Processing Time Days
- 34
- Number Of Sites
- 10
- Number Of Participants
- 22
Sites
- Site Name
- Clinica Baviera S.A.
- Department Name
- Ophthalmology
- Contact Person Name
- Marta Suárez de Figueroa
- Contact Person Email
- figueroa.marta@outlook.es
- Site Name
- Metavision Arruzafa S.L.
- Department Name
- Ophthalmology
- Contact Person Name
- Juan Manuel Cubero Parra
- Contact Person Email
- jmcubero@hospitalarruzafa.com
- Site Name
- Bellvitge University Hospital
- Department Name
- Ophthalmology
- Contact Person Name
- Luis Arias Barquet
- Contact Person Email
- luisariasbarquet@gmail.com
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Ophthalmology
- Contact Person Name
- Anna Sala Puigdollers
- Contact Person Email
- ansala@clinic.cat
- Site Name
- Hospital Universitario Puerta De Hierro De Majadahonda
- Department Name
- Ophthalmology
- Contact Person Name
- Jose María Ruíz Moreno
- Contact Person Email
- josemaria.ruiz@uclm.es
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Ophthalmology
- Contact Person Name
- Luis Francisco Moreno García
- Contact Person Email
- luisfco.moreno@salud.madrid.org
- Site Name
- Hospital Provincial De Conxo
- Department Name
- Ophthalmology
- Contact Person Name
- Maximino José Abraldes López-Veiga
- Contact Person Email
- maxiabraldes@gmail.com
- Site Name
- Complejo Hospitalario Universitario Insular Materno Infantil
- Department Name
- Ophthalmology
- Contact Person Name
- Francisco Cabrera López
- Contact Person Email
- pacooft@gmail.com
- Site Name
- Instituto De Microcirugia Ocular Dos S.L.
- Department Name
- Ophthalmology
- Contact Person Name
- Rafael Navarro Alemany
- Contact Person Email
- rafael.navarro@imo.es
- Site Name
- Hospital De La Santa Creu I Sant Pau
- Department Name
- Ophthalmology
- Contact Person Name
- José Ignacio Vela Segarra
- Contact Person Email
- ivela@santpau.cat
Germany
- Earliest CTIS Part Ii Submission Date
- 26-06-2025
- Latest Decision Or Authorization Date
- 23-01-2026
- Processing Time Days
- 211
- Number Of Sites
- 6
- Number Of Participants
- 12
Sites
- Site Name
- Medical Center - University Of Freiburg
- Contact Person Name
- Hansjuergen Agostini
- Contact Person Email
- Hansjuergen.agostini@uniklinik-freiburg.de
- Site Name
- Klinikum der Stadt Ludwigshafen am Rhein gGmbH
- Contact Person Name
- Lars-Olof Hattenbach
- Contact Person Email
- Hattenbach.studien@klilu.de
- Site Name
- Universitaetsklinikum Ulm AöR
- Department Name
- Abteilung für Augenheilkunde
- Contact Person Name
- Armin Wolf
- Contact Person Email
- Armin.wolf@uniklinikum-ulm.de
- Site Name
- Universitaet Muenster
- Department Name
- Klinik fuer Augenheilkunde
- Contact Person Name
- Nicole Eter
- Contact Person Email
- Direktorin.augenklinik@ukmuenster.de
- Site Name
- Universitaetsklinikum Bonn AöR
- Department Name
- Department Ophthalmology
- Contact Person Name
- Kristina Pfau
- Contact Person Email
- kristina.pfau@ukbonn.de
- Site Name
- University Medical Center Hamburg-Eppendorf
- Department Name
- Klinik und Poliklinik für Augenheilkunde
- Contact Person Name
- Martin Spitzer
- Contact Person Email
- m.spitzer@uke.de
Sponsor
Primary sponsor
- Full Name
- AbbVie Deutschland GmbH & Co. KG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Germany
Contract research organisations
- Name
- Syneos Health Netherlands B.V.
- Name
- Merit CRO Inc.
- Responsibilities
- Imaging center
Third parties
- {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Patient compensation","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Transperfect Translations International Inc.","duties_or_roles":"Translation services","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Optymedge LLC","duties_or_roles":"Visual acuity examiner and lane certification","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Netherlands","full_name":"Syneos Health Netherlands B.V.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Merit CRO Inc.","duties_or_roles":"Imaging center","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
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