Clinical trial • Phase III • Ophthalmology
SURABGENE LOMPARVOVEC (AAV8 vector encoding anti-VEGF antigen-binding fragment; synonyms: RGX-314, ABBV-RGX-314) for Neovascular age-related macular degeneration
Phase III trial of SURABGENE LOMPARVOVEC (AAV8 vector encoding anti-VEGF antigen-binding fragment; synonyms: RGX-314, ABBV-RGX-314) for Neovascular age-re…
Overview
- Trial Therapeutic Area
- Ophthalmology
- Trial Disease
- Neovascular age-related macular degeneration
- Trial Stage
- Phase III
- Drug Modality
- Gene therapy | Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 17-07-2025
- First CTIS Authorization Date
- 02-12-2025
Trial design
Randomised, ranibizumab (lucentis 10 mg/ml solution for injection in pre-filled syringe); administered intravitreally on a prn basis per protocol-specified criteria during year 1 and subsequently on a prn schedule that mimics real-world clinical practice after year 1.-controlled Phase III trial in Austria, Belgium, Bulgaria and others.
- Randomised
- Yes
- Comparator
- Ranibizumab (Lucentis 10 mg/ml solution for injection in pre-filled syringe); administered intravitreally on a PRN basis per protocol-specified criteria during Year 1 and subsequently on a PRN schedule that mimics real-world clinical practice after Year 1.
- Real World Control
- Yes
- Target Sample Size
- 289
- Trial Duration For Participant
- 1095
Eligibility
Recruits 289 No vulnerable populations selected. Trial enrols adult participants only (public title and inclusion criteria specify adult participants). Informed consent is obtained from participants; country-specific ICFs (including pregnant partner ICFs) are provided. No paediatric assent procedures are indicated..
- Vulnerable Population
- No vulnerable populations selected. Trial enrols adult participants only (public title and inclusion criteria specify adult participants). Informed consent is obtained from participants; country-specific ICFs (including pregnant partner ICFs) are provided. No paediatric assent procedures are indicated.
Inclusion criteria
- {"criterion_text":"- Pseudophakic (at least 12 weeks post cataract surgery at Screening Visit 1 [Week –6]) in the study eye"}
- {"criterion_text":"- Must have a diagnosis of CNV secondary to AMD in the study eye"}
- {"criterion_text":"- Must have received at least 2 intravitreal anti-VEGF injections in the past 6 months in the study eye prior to Screening Visit 1 (Week –6) and have been responsive (determined by investigator)"}
Exclusion criteria
- {"criterion_text":"- CNV or macular edema in the study eye that is secondary to any causes other than AMD."}
- {"criterion_text":"- Study eye with nAMD diagnosed > 4 years from Screening Visit 1"}
- {"criterion_text":"- Any subretinal hemorrhage in the study eye > 50% of the total lesion area or within the parafovea (3 mm center of the macula), as determined by the central reading center."}
- {"criterion_text":"- History of retinal detachment, retinal tear or macular hole in the study eye that, in the opinion of the investigator, may preclude successful subretinal injection of surabgene lomparvovec."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Annualized intravitreal anti-VEGF injection rate from Week 6 through Week 54.","definition_or_measurement_approach":"Annualized intravitreal anti-VEGF injection rate measured from Week 6 through Week 54 (rate of intravitreal anti-VEGF injections per year calculated over this interval)."}
Secondary endpoints
- {"endpoint_text":"- Change from Baseline in BCVA at Year 3.","definition_or_measurement_approach":"Change from baseline in best-corrected visual acuity (BCVA) measured at Year 3 compared to baseline."}
- {"endpoint_text":"- Annualized intravitreal anti-VEGF injection rate from Week 6 through Year 3.","definition_or_measurement_approach":"Annualized intravitreal anti-VEGF injection rate measured from Week 6 through Year 3 (rate of injections per year over this interval)."}
- {"endpoint_text":"- Incidence and severity of ocular AEs in the study eye and contralateral eye","definition_or_measurement_approach":"Recording and grading of ocular adverse events (incidence and severity) in both study and contralateral eyes per study safety reporting procedures."}
- {"endpoint_text":"- Change from Baseline in area of macular atrophy based on FAF at assessed time points in the study eye","definition_or_measurement_approach":"Change from baseline in macular atrophy area assessed by fundus autofluorescence (FAF) imaging at scheduled time points."}
Recruitment
- Planned Sample Size
- 289
- Recruitment Window Months
- 85
- Consent Approach
- Informed consent obtained from adult participants. Country-specific subject information and informed consent forms (ICFs) are provided (multiple languages / country-specific ICFs available as listed in the application documents). Pregnant-partner ICFs are available where applicable. Consent is provided by the participant; no paediatric assent is indicated.
Geography
- Total Number Of Sites
- 75
- Total Number Of Participants
- 272
Austria
- Earliest CTIS Part Ii Submission Date
- 30-09-2025
- Latest Decision Or Authorization Date
- 08-12-2025
- Processing Time Days
- 69
- Number Of Sites
- 5
- Number Of Participants
- 20
Sites
- Site Name
- Gemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft mbH
- Department Name
- Department of Opthalmology
- Principal Investigator Name
- Herbert Reitsamer
- Principal Investigator Email
- h.reitsamer@salk.at
- Contact Person Name
- Herbert Reitsamer
- Contact Person Email
- h.reitsamer@salk.at
- Site Name
- Medizinische Universitaet Innsbruck
- Department Name
- Department of Ophthalmology and Optometry
- Principal Investigator Name
- Matus Rehak
- Principal Investigator Email
- matus.rehak@i-med.ac.at
- Contact Person Name
- Matus Rehak
- Contact Person Email
- matus.rehak@i-med.ac.at
- Site Name
- NOE Landesgesundheitsagentur
- Department Name
- Department of Opthalmology
- Principal Investigator Name
- Sebastian Waldstein
- Principal Investigator Email
- sebastian.waldstein@mistelbach.lknoe.at
- Contact Person Name
- Sebastian Waldstein
- Contact Person Email
- sebastian.waldstein@mistelbach.lknoe.at
- Site Name
- Medical University Of Graz
- Department Name
- Department of Ophthalmology
- Principal Investigator Name
- Anton Haas
- Principal Investigator Email
- anton.haas@medunigraz.at
- Contact Person Name
- Anton Haas
- Contact Person Email
- anton.haas@medunigraz.at
- Site Name
- Johannes Kepler University Linz
- Department Name
- Department of Ophthalmology and Optometry
- Principal Investigator Name
- Matthias Bolz
- Principal Investigator Email
- matthias.bolz@kepleruniklinikum.at
- Contact Person Name
- Matthias Bolz
- Contact Person Email
- matthias.bolz@kepleruniklinikum.at
Belgium
- Earliest CTIS Part Ii Submission Date
- 06-10-2025
- Latest Decision Or Authorization Date
- 03-12-2025
- Processing Time Days
- 58
- Number Of Sites
- 2
- Number Of Participants
- 8
Sites
- Site Name
- UZ Leuven
- Department Name
- Oogheelkunde
- Principal Investigator Name
- Julie Jacob
- Principal Investigator Email
- julie.jacob@uzleuven.be
- Contact Person Name
- Julie Jacob
- Contact Person Email
- julie.jacob@uzleuven.be
- Site Name
- Universitair Ziekenhuis Gent
- Department Name
- Oogheelkunde
- Principal Investigator Name
- Julie De Zaeytijd
- Principal Investigator Email
- julie.dezaeytijd@uzgent.be
- Contact Person Name
- Julie De Zaeytijd
- Contact Person Email
- julie.dezaeytijd@uzgent.be
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 13-10-2025
- Latest Decision Or Authorization Date
- 08-12-2025
- Processing Time Days
- 56
- Number Of Sites
- 4
- Number Of Participants
- 16
Sites
- Site Name
- Assoc. Prof. Dr. Desislava Koleva Outpatient clinic for individual practice for specialized medical assistance in eye diseases "St. Luka" EOOD
- Principal Investigator Name
- Desislava Koleva-Georgieva
- Principal Investigator Email
- dr_desikoleva@yahoo.com
- Contact Person Name
- Desislava Koleva-Georgieva
- Contact Person Email
- dr_desikoleva@yahoo.com
- Site Name
- Specialized Eye Hospital For Active Treatment Burgas OOD
- Department Name
- Department - Eye Diseases
- Principal Investigator Name
- Dimitar Grupchev
- Principal Investigator Email
- dgrupchev@gmail.com
- Contact Person Name
- Dimitar Grupchev
- Contact Person Email
- dgrupchev@gmail.com
- Site Name
- Medical Center Vereya EOOD
- Principal Investigator Name
- Dimitar Dzhelebov
- Principal Investigator Email
- dzhelebov@gmail.com
- Contact Person Name
- Dimitar Dzhelebov
- Contact Person Email
- dzhelebov@gmail.com
- Site Name
- Specialized Hospital For Active Treatment Of Eye Diseases Zora OOD
- Department Name
- Department - Eye Diseases
- Principal Investigator Name
- Iva Petkova
- Principal Investigator Email
- ivapetkova@abv.bg
- Contact Person Name
- Iva Petkova
- Contact Person Email
- ivapetkova@abv.bg
Croatia
- Earliest CTIS Part Ii Submission Date
- 17-09-2025
- Latest Decision Or Authorization Date
- 08-12-2025
- Processing Time Days
- 82
- Number Of Sites
- 3
- Number Of Participants
- 12
Sites
- Site Name
- University Hospital Sveti Duh
- Department Name
- Ophthalmology
- Principal Investigator Name
- Damir Bosnar
- Principal Investigator Email
- ocna@kbsd.hr
- Contact Person Name
- Damir Bosnar
- Contact Person Email
- ocna@kbsd.hr
- Site Name
- Specijalna bolnica Svjetlost
- Department Name
- Ophthalmology
- Principal Investigator Name
- Ratimir Lazić
- Principal Investigator Email
- tajnica@svjetlost.hr
- Contact Person Name
- Ratimir Lazić
- Contact Person Email
- tajnica@svjetlost.hr
- Site Name
- University Hospital Centre Zagreb
- Department Name
- Ophthalmology
- Principal Investigator Name
- Tomislav Jukić
- Principal Investigator Email
- predstojnik.oci@kbc-zagreb.hr
- Contact Person Name
- Tomislav Jukić
- Contact Person Email
- predstojnik.oci@kbc-zagreb.hr
Czechia
- Earliest CTIS Part Ii Submission Date
- 10-10-2025
- Latest Decision Or Authorization Date
- 04-12-2025
- Processing Time Days
- 55
- Number Of Sites
- 5
- Number Of Participants
- 20
Sites
- Site Name
- Fakultni Nemocnice Kralovske Vinohrady
- Department Name
- Oftalmologická klinika
- Principal Investigator Name
- Miroslav Veith
- Principal Investigator Email
- miroslav.veith@fnkv.cz
- Contact Person Name
- Miroslav Veith
- Contact Person Email
- miroslav.veith@fnkv.cz
- Site Name
- Fakultni Nemocnice Ostrava
- Department Name
- Ocni klinika FNO
- Principal Investigator Name
- Jan Nemcansky
- Principal Investigator Email
- jan.nemcansky@fno.cz
- Contact Person Name
- Jan Nemcansky
- Contact Person Email
- jan.nemcansky@fno.cz
- Site Name
- Vseobecna Fakultni Nemocnice V Praze
- Department Name
- Ocni klinika VFN
- Principal Investigator Name
- Bohdan Kousal
- Principal Investigator Email
- bohdan.kousal@vfn.cz
- Contact Person Name
- Bohdan Kousal
- Contact Person Email
- bohdan.kousal@vfn.cz
- Site Name
- Axon Clinical s.r.o.
- Department Name
- Ocni oddeleni
- Principal Investigator Name
- Jan Ernest
- Principal Investigator Email
- jan.ernest@axon-clinical.com
- Contact Person Name
- Jan Ernest
- Contact Person Email
- jan.ernest@axon-clinical.com
- Site Name
- Ustredni Vojenska Nemocnice Vojenska Fakultni Nemocnice Praha
- Department Name
- Ocni klinika UVN
- Principal Investigator Name
- Martin Šín
- Principal Investigator Email
- sin.martin@uvn.cz
- Contact Person Name
- Martin Šín
- Contact Person Email
- sin.martin@uvn.cz
France
- Earliest CTIS Part Ii Submission Date
- 22-10-2025
- Latest Decision Or Authorization Date
- 11-05-2026
- Processing Time Days
- 201
- Number Of Sites
- 13
- Number Of Participants
- 40
Sites
- Site Name
- Pole Vision Val D'Ouest
- Department Name
- Ophthalmology
- Principal Investigator Name
- Pierre Loic CORNUT
- Principal Investigator Email
- direction@polevision.fr
- Contact Person Name
- Pierre Loic CORNUT
- Contact Person Email
- direction@polevision.fr
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- Ophthalmology
- Principal Investigator Name
- Olivier LEBRETON
- Principal Investigator Email
- olivier.lebreton@chu-nantes.fr
- Contact Person Name
- Olivier LEBRETON
- Contact Person Email
- olivier.lebreton@chu-nantes.fr
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- Ophthalmology
- Principal Investigator Name
- Marie-Noelle DELYFER
- Principal Investigator Email
- marie-noelle.delyfer@chu-bordeaux.fr
- Contact Person Name
- Marie-Noelle DELYFER
- Contact Person Email
- marie-noelle.delyfer@chu-bordeaux.fr
- Site Name
- Clinique Juge
- Department Name
- Ophtalmology
- Principal Investigator Name
- François Devin
- Principal Investigator Email
- fdbm.retine@gmail.com
- Contact Person Name
- François Devin
- Contact Person Email
- fdbm.retine@gmail.com
- Site Name
- Centre Hospitalier Universitaire De Nice
- Department Name
- Ophthalmology
- Principal Investigator Name
- Stéphanie Baillif
- Principal Investigator Email
- baillif.s@chu-nice.fr
- Contact Person Name
- Stéphanie Baillif
- Contact Person Email
- baillif.s@chu-nice.fr
- Site Name
- Institut Ophtalmologique De l'Ouest Jules Verne
- Department Name
- Clinique Jules Verne
- Principal Investigator Name
- Frank BECQUET
- Principal Investigator Email
- frankbecquet@yahoo.fr
- Contact Person Name
- Frank BECQUET
- Contact Person Email
- frankbecquet@yahoo.fr
- Site Name
- Hospital Edouard Herriot
- Department Name
- Ophthalmology
- Principal Investigator Name
- Corinne DOT
- Principal Investigator Email
- corinne.dot@chu-lyon.fr
- Contact Person Name
- Corinne DOT
- Contact Person Email
- corinne.dot@chu-lyon.fr
- Site Name
- Centre Monticelli Paradis D Ophtalmologie
- Department Name
- Ophtalmology
- Principal Investigator Name
- François DEVIN
- Principal Investigator Email
- fdbm.retine@gmail.com
- Contact Person Name
- François DEVIN
- Contact Person Email
- fdbm.retine@gmail.com
- Site Name
- Selarl Retine Tourny
- Department Name
- Centre Rétine Galien
- Principal Investigator Name
- Laurence Rosier
- Principal Investigator Email
- Laurence.rosier@retinegallien.com
- Contact Person Name
- Laurence Rosier
- Contact Person Email
- Laurence.rosier@retinegallien.com
- Site Name
- Centre Hospitalier Intercommunal Creteil
- Department Name
- Ophthalmology
- Principal Investigator Name
- Eric SOUEID
- Principal Investigator Email
- eric.soueid@chicreteil.fr
- Contact Person Name
- Eric SOUEID
- Contact Person Email
- eric.soueid@chicreteil.fr
- Site Name
- Centre Hospitalier National d'Ophtalmologie des Quize-Vingts
- Department Name
- Ophthalmology
- Principal Investigator Name
- Jean-François GIRMENS
- Principal Investigator Email
- nbrouk@15-20.fr
- Contact Person Name
- Jean-François GIRMENS
- Contact Person Email
- nbrouk@15-20.fr
- Site Name
- Fondation A De Rothschild
- Department Name
- Ophthalmology
- Principal Investigator Name
- Sébastien Bruneau
- Principal Investigator Email
- sbruneau@for.paris
- Contact Person Name
- Sébastien Bruneau
- Contact Person Email
- sbruneau@for.paris
Germany
- Earliest CTIS Part Ii Submission Date
- 24-10-2025
- Latest Decision Or Authorization Date
- 22-04-2026
- Processing Time Days
- 180
- Number Of Sites
- 12
- Number Of Participants
- 40
Sites
- Site Name
- Universitaetsklinikum Ulm AöR
- Department Name
- Klinik fuer Augenheilkunde
- Principal Investigator Name
- Armin Wolf
- Principal Investigator Email
- studienzentrale.augenklinik@uniklinik-ulm.de
- Contact Person Name
- Armin Wolf
- Contact Person Email
- studienzentrale.augenklinik@uniklinik-ulm.de
- Site Name
- LMU Klinikum Muenchen AöR
- Department Name
- Augenklinik und Poliklinik
- Principal Investigator Name
- Siegfried Priglinger
- Principal Investigator Email
- Maximilian.gerhardt@med.uni-muenchen.de
- Contact Person Name
- Siegfried Priglinger
- Contact Person Email
- Maximilian.gerhardt@med.uni-muenchen.de
- Site Name
- Medizinische Hochschule Hannover
- Department Name
- Universitaetsklinik fuer Augenheilkunde
- Principal Investigator Name
- Ekaterina Sokolenko
- Principal Investigator Email
- Augenklinik.Studien@mh-hannover.de
- Contact Person Name
- Ekaterina Sokolenko
- Contact Person Email
- Augenklinik.Studien@mh-hannover.de
- Site Name
- Universitaetsklinikum Bonn AöR
- Department Name
- Klinik fuer Augenheilkunde
- Principal Investigator Name
- Frank G Holz
- Principal Investigator Email
- Gamze.Bildik@ukbonn.de
- Contact Person Name
- Frank G Holz
- Contact Person Email
- Gamze.Bildik@ukbonn.de
- Site Name
- Universitaet Muenster
- Department Name
- Klinik fuer Augenheilkunde
- Principal Investigator Name
- Nicole Eter
- Principal Investigator Email
- Augenklinik-studien@ukmuenster.de
- Contact Person Name
- Nicole Eter
- Contact Person Email
- Augenklinik-studien@ukmuenster.de
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- Klinik fuer Augenheilkunde
- Principal Investigator Name
- Antonia Joussen
- Principal Investigator Email
- studien-augenklinik-cbf@charite.de
- Contact Person Name
- Antonia Joussen
- Contact Person Email
- studien-augenklinik-cbf@charite.de
- Site Name
- Klinikum der Stadt Ludwigshafen am Rhein gGmbH
- Department Name
- Augenklinik
- Principal Investigator Name
- Lars-Olof Hattenbach
- Principal Investigator Email
- Studien_augenklinik@klilu.de
- Contact Person Name
- Lars-Olof Hattenbach
- Contact Person Email
- Studien_augenklinik@klilu.de
- Site Name
- Medical Center - University Of Freiburg
- Department Name
- Klinik fuer Augenheilkunde
- Principal Investigator Name
- Hansjürgen Agostini
- Principal Investigator Email
- hansjuergen.agostini@uniklinik-freiburg.de
- Contact Person Name
- Hansjürgen Agostini
- Contact Person Email
- hansjuergen.agostini@uniklinik-freiburg.de
- Site Name
- Universitaetsklinikum Tuebingen AöR
- Department Name
- Universitaets-Augenklinik
- Principal Investigator Name
- Karl Ulrich Bartz-Schmidt
- Principal Investigator Email
- studien.augenklinik@med.uni-tuebingen.de
- Contact Person Name
- Karl Ulrich Bartz-Schmidt
- Contact Person Email
- studien.augenklinik@med.uni-tuebingen.de
- Site Name
- Universitaetsmedizin Goettingen
- Department Name
- Klinik fuer Augenheilkunde
- Principal Investigator Name
- Sebastian Bemme
- Principal Investigator Email
- Augenklinik.studiensekretariat@med.uni-goettingen.de
- Contact Person Name
- Sebastian Bemme
- Contact Person Email
- Augenklinik.studiensekretariat@med.uni-goettingen.de
- Site Name
- University Medical Center Hamburg-Eppendorf
- Department Name
- Augenheilkunde
- Principal Investigator Name
- Martin Spitzer
- Principal Investigator Email
- Studien-Augenklinik@uke.de
- Contact Person Name
- Martin Spitzer
- Contact Person Email
- Studien-Augenklinik@uke.de
- Site Name
- Universitaetsklinikum Schleswig-Holstein AöR
- Department Name
- Klinik fuer Augenheilkunde
- Principal Investigator Name
- Salvatore Grisanti
- Principal Investigator Email
- Studien.augenklinik.luebeck@uksh.de
- Contact Person Name
- Salvatore Grisanti
- Contact Person Email
- Studien.augenklinik.luebeck@uksh.de
Greece
- Earliest CTIS Part Ii Submission Date
- 31-10-2025
- Latest Decision Or Authorization Date
- 02-12-2025
- Processing Time Days
- 32
- Number Of Sites
- 4
- Number Of Participants
- 16
Sites
- Site Name
- General Hospital Of Athens G Gennimatas
- Department Name
- First University Ophthalmology Department
- Principal Investigator Name
- Ilias Georgalas
- Principal Investigator Email
- igeorgalas@yahoo.com
- Contact Person Name
- Ilias Georgalas
- Contact Person Email
- igeorgalas@yahoo.com
- Site Name
- University General Hospital Of Heraklion
- Department Name
- Ophthalmology Department
- Principal Investigator Name
- Miltiadis Tsilimbaris
- Principal Investigator Email
- tsilimb@med.uoc.gr
- Contact Person Name
- Miltiadis Tsilimbaris
- Contact Person Email
- tsilimb@med.uoc.gr
- Site Name
- University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
- Department Name
- 2nd University Department of Ophthalmology
- Principal Investigator Name
- Eirini Chatziralli
- Principal Investigator Email
- eirchat@med.uoa.gr
- Contact Person Name
- Eirini Chatziralli
- Contact Person Email
- eirchat@med.uoa.gr
- Site Name
- General University Hospital Of Larissa
- Department Name
- University Eye Clinic
- Principal Investigator Name
- Sofia Androudi
- Principal Investigator Email
- androudi@otenet.gr
- Contact Person Name
- Sofia Androudi
- Contact Person Email
- androudi@otenet.gr
Hungary
- Earliest CTIS Part Ii Submission Date
- 08-10-2025
- Latest Decision Or Authorization Date
- 08-12-2025
- Processing Time Days
- 61
- Number Of Sites
- 4
- Number Of Participants
- 16
Sites
- Site Name
- Budapest Retina Associates Kft.
- Department Name
- Budapest Retina Associates
- Principal Investigator Name
- Andras Seres
- Principal Investigator Email
- seres@budapestretina.hu
- Contact Person Name
- Andras Seres
- Contact Person Email
- seres@budapestretina.hu
- Site Name
- Semmelweis University
- Department Name
- Szemeszeti Klinika, Szemeszeti Klinikai Kutato Kozpont
- Principal Investigator Name
- Andras Papp
- Principal Investigator Email
- papp.andras1@semmelweis.hu
- Contact Person Name
- Andras Papp
- Contact Person Email
- papp.andras1@semmelweis.hu
- Site Name
- University Of Debrecen
- Department Name
- Szemklinika
- Principal Investigator Name
- Attila Vajas
- Principal Investigator Email
- vajasa@gmail.com
- Contact Person Name
- Attila Vajas
- Contact Person Email
- vajasa@gmail.com
- Site Name
- Nozologen Kft.
- Department Name
- Ganglion Orvosi Kozpont
- Principal Investigator Name
- Balazs Varsanyi
- Principal Investigator Email
- info@ganglion.hu
- Contact Person Name
- Balazs Varsanyi
- Contact Person Email
- info@ganglion.hu
Portugal
- Earliest CTIS Part Ii Submission Date
- 19-09-2025
- Latest Decision Or Authorization Date
- 02-12-2025
- Processing Time Days
- 74
- Number Of Sites
- 3
- Number Of Participants
- 12
Sites
- Site Name
- Unidade Local De Saude De Sao Jose E.P.E.
- Department Name
- Opthalmic Service
- Principal Investigator Name
- Rita Flores
- Principal Investigator Email
- ritamariaflores@gmail.com
- Contact Person Name
- Rita Flores
- Contact Person Email
- ritamariaflores@gmail.com
- Site Name
- Unidade Local De Saude De Coimbra E.P.E.
- Department Name
- Opthalmic Service
- Principal Investigator Name
- João Marques
- Principal Investigator Email
- marquesjoaopedro@gmail.com
- Contact Person Name
- João Marques
- Contact Person Email
- marquesjoaopedro@gmail.com
- Site Name
- Unidade Local De Saude De Santo Antonio E.P.E.
- Department Name
- Opthalmic Service
- Principal Investigator Name
- Miguel Lume
- Principal Investigator Email
- miguelribeirolume@gmail.com
- Contact Person Name
- Miguel Lume
- Contact Person Email
- miguelribeirolume@gmail.com
Slovakia
- Earliest CTIS Part Ii Submission Date
- 02-10-2025
- Latest Decision Or Authorization Date
- 02-12-2025
- Processing Time Days
- 61
- Number Of Sites
- 3
- Number Of Participants
- 12
Sites
- Site Name
- University Hospital Bratislava
- Department Name
- Ophtalmology
- Principal Investigator Name
- Petr Kolar
- Principal Investigator Email
- ocne.sekretariat@pe.unb.sk
- Contact Person Name
- Petr Kolar
- Contact Person Email
- ocne.sekretariat@pe.unb.sk
- Site Name
- Fakultna Nemocnica Trencín
- Department Name
- Ophtalmology
- Principal Investigator Name
- Marek Kacerik
- Principal Investigator Email
- marek.kacerik@fntn.sk
- Contact Person Name
- Marek Kacerik
- Contact Person Email
- marek.kacerik@fntn.sk
- Site Name
- Fakultna Nemocnica S Poliklinikou Zilina
- Department Name
- Ophtalmology
- Principal Investigator Name
- Milan Veselovsky
- Principal Investigator Email
- lubica.libicova@fnspza.sk
- Contact Person Name
- Milan Veselovsky
- Contact Person Email
- lubica.libicova@fnspza.sk
Spain
- Earliest CTIS Part Ii Submission Date
- 08-10-2025
- Latest Decision Or Authorization Date
- 23-02-2026
- Processing Time Days
- 138
- Number Of Sites
- 11
- Number Of Participants
- 40
Sites
- Site Name
- Metavision Arruzafa S.L.
- Department Name
- Ophthalmology
- Principal Investigator Name
- Juan Manuel Cubero Parra
- Principal Investigator Email
- jmcp@hospitalarruzafa.com
- Contact Person Name
- Juan Manuel Cubero Parra
- Contact Person Email
- jmcp@hospitalarruzafa.com
- Site Name
- Hospital Universitario Virgen De La Macarena
- Department Name
- Ophthalmology
- Principal Investigator Name
- Enrique Rodríguez de la Rua Franch
- Principal Investigator Email
- erdelarua@gmail.com
- Contact Person Name
- Enrique Rodríguez de la Rua Franch
- Contact Person Email
- erdelarua@gmail.com
- Site Name
- Instituto Clinic De Oftalmologia
- Department Name
- Ophthalmology
- Principal Investigator Name
- Anna Sala Puigdollers
- Principal Investigator Email
- ansala@clinic.cat
- Contact Person Name
- Anna Sala Puigdollers
- Contact Person Email
- ansala@clinic.cat
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Ophthalmology
- Principal Investigator Name
- Miguel Ángel Zapata Victori
- Principal Investigator Email
- miguelangel.zapata@vallhebron.cat
- Contact Person Name
- Miguel Ángel Zapata Victori
- Contact Person Email
- miguelangel.zapata@vallhebron.cat
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Ophthalmology
- Principal Investigator Name
- Patricia Udaondo Mirete
- Principal Investigator Email
- draudaondo@gmail.com
- Contact Person Name
- Patricia Udaondo Mirete
- Contact Person Email
- draudaondo@gmail.com
- Site Name
- Hospital Universitario Donostia
- Department Name
- Ophthalmology
- Principal Investigator Name
- Cristina Irigoyen Laborra
- Principal Investigator Email
- cristina.irigoyenlaborra@osakidetza.eus
- Contact Person Name
- Cristina Irigoyen Laborra
- Contact Person Email
- cristina.irigoyenlaborra@osakidetza.eus
- Site Name
- Hospital Clinico Universitario Lozano Blesa
- Department Name
- Ophthalmology
- Principal Investigator Name
- Francisco Javier Ascaso Puyuelo
- Principal Investigator Email
- jascaso@gmail.com
- Contact Person Name
- Francisco Javier Ascaso Puyuelo
- Contact Person Email
- jascaso@gmail.com
- Site Name
- Centro De Oftalmologia Barraquer S.A.
- Department Name
- Ophthalmology
- Principal Investigator Name
- Santiago Abengoechea Hernández
- Principal Investigator Email
- sah@barraquer.com
- Contact Person Name
- Santiago Abengoechea Hernández
- Contact Person Email
- sah@barraquer.com
- Site Name
- Hospital Universitario Puerta De Hierro De Majadahonda
- Department Name
- Ophthalmology
- Principal Investigator Name
- Jose María Ruiz Moreno
- Principal Investigator Email
- josemaria.ruiz@uclm.es
- Contact Person Name
- Jose María Ruiz Moreno
- Contact Person Email
- josemaria.ruiz@uclm.es
- Site Name
- Instituto Oftalmologico Fernandez-Vega S.L.
- Department Name
- Ophthalmology
- Principal Investigator Name
- Álvaro Fernández-Vega Sanz
- Principal Investigator Email
- investigacion@fernandez-vega.com
- Contact Person Name
- Álvaro Fernández-Vega Sanz
- Contact Person Email
- investigacion@fernandez-vega.com
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Ophthalmology
- Principal Investigator Name
- Luis Francisco Moreno García
- Principal Investigator Email
- Luisfco.moreno@salud.madrid.org
- Contact Person Name
- Luis Francisco Moreno García
- Contact Person Email
- Luisfco.moreno@salud.madrid.org
Italy
- Earliest CTIS Part Ii Submission Date
- 07-10-2025
- Latest Decision Or Authorization Date
- 24-03-2026
- Processing Time Days
- 168
- Number Of Sites
- 6
- Number Of Participants
- 20
Sites
- Site Name
- Azienda USL IRCCS Di Reggio Emilia
- Department Name
- Ocular Immunology Unit
- Principal Investigator Name
- Luca Cimino
- Principal Investigator Email
- luca.cimino@ausl.re.it
- Contact Person Name
- Luca Cimino
- Contact Person Email
- luca.cimino@ausl.re.it
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- UOC Oculistica
- Principal Investigator Name
- Angelo Maria Minnella
- Principal Investigator Email
- angelomaria.minnella@policlinicogemelli.it
- Contact Person Name
- Angelo Maria Minnella
- Contact Person Email
- angelomaria.minnella@policlinicogemelli.it
- Site Name
- Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
- Department Name
- Oculistica
- Principal Investigator Name
- Michele Reibaldi
- Principal Investigator Email
- michele.reibaldi@unito.it
- Contact Person Name
- Michele Reibaldi
- Contact Person Email
- michele.reibaldi@unito.it
- Site Name
- Azienda Ospedaliero Universitaria Careggi
- Department Name
- SOD Ottica Fisiopatologica
- Principal Investigator Name
- Fabrizio Giansanti
- Principal Investigator Email
- fabrizio.giansanti@unifi.it
- Contact Person Name
- Fabrizio Giansanti
- Contact Person Email
- fabrizio.giansanti@unifi.it
- Site Name
- University Hospital Of Ferrara
- Department Name
- Dipartimento di Medicina Traslazionale e per la Romagna
- Principal Investigator Name
- Marco Mura
- Principal Investigator Email
- dmtr@unife.it
- Contact Person Name
- Marco Mura
- Contact Person Email
- dmtr@unife.it
- Site Name
- Azienda Ospedaliero Universitaria Delle Marche
- Department Name
- Clinica Oculistica
- Principal Investigator Name
- Cesare Mariotti
- Principal Investigator Email
- cesare.mariotti@ospedaliriuniti.marche.it
- Contact Person Name
- Cesare Mariotti
- Contact Person Email
- cesare.mariotti@ospedaliriuniti.marche.it
Sponsor
Primary sponsor
- Full Name
- AbbVie Deutschland GmbH & Co. KG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Germany
Contract research organisations
- Name
- Merit CRO Inc.
- Responsibilities
- Central reading center
- Name
- Iqvia Rds Inc.
- Responsibilities
- IRT-global.helpdesk (operational support) (code: 3)
- Name
- WCG Clinical Inc.
- Responsibilities
- Patient Recruitment
- Name
- Veranex Inc.
- Responsibilities
- Investigator training
Third parties
- {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"codes: 6,7","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Merit CRO Inc.","duties_or_roles":"Central reading center","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Azenta US Inc.","duties_or_roles":"code: 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Optymedge LLC","duties_or_roles":"Visual function exam certification","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Avantor Inc.","duties_or_roles":"Study equipment rental","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Patient transportation","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"code: 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"Patient Recruitment","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Iqvia Rds Inc.","duties_or_roles":"code: 3","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Veranex Inc.","duties_or_roles":"Investigator training","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Cytel Inc.","duties_or_roles":"Data monitoring committee","organisation_type":"Non-Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Surabgene Lomparvovec (ABBV-RGX-314)
- Active Substance
- SURABGENE LOMPARVOVEC (AAV8 vector encoding anti-VEGF antigen-binding fragment; synonyms: RGX-314, ABBV-RGX-314)
- Modality
- Gene therapy
- Routes Of Administration
- SUBRETINAL USE
- Route
- Subretinal
- Authorisation Status
- Not authorised
- Investigational Product Name
- Lucentis 10 mg/ml solution for injection in pre-filled syringe (ranibizumab)
- Active Substance
- RANIBIZUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVITREAL USE
- Route
- Intravitreal
- Authorisation Status
- Authorised
- Frequency
- PRN per protocol (Year 1) then PRN real-world schedule after Year 1
Related trials
Other published trials that may interest you.