Clinical trial • Phase IV • Ophthalmology
Adeno-associated virus serotype 2 encoding soluble CD59 for Geographic atrophy secondary to age-related macular degeneration
Phase IV trial of Adeno-associated virus serotype 2 encoding soluble CD59 for Geographic atrophy secondary to age-related macular degeneration.
Overview
- Trial Therapeutic Area
- Ophthalmology
- Trial Disease
- Geographic atrophy secondary to age-related macular degeneration
- Trial Stage
- Phase IV
- Drug Modality
- Gene therapy | Small molecule
Key dates
- Initial CTIS Submission Date
- 23-07-2024
- First CTIS Authorization Date
- 19-11-2024
Trial design
None/Not specified-controlled Phase IV trial across 44 sites in Belgium, Czechia, Spain and others.
- Comparator
- None/Not specified
- Target Sample Size
- 182
- Trial Duration For Participant
- 1642
Eligibility
Recruits 182 isVulnerablePopulationSelected = true. Consent: "Must sign an ICF indicating that participant understands the purpose of, and procedures required for, the study and is willing to participate in the study. The ICF may be signed by an impartial witness and/or legally designated representative depending on national/local regulations." Country-specific ICFs and appendices (including privacy appendix for child and pregnant partner documents) are provided; assent procedures are not explicitly detailed in the provided criteria..
- Vulnerable Population
- isVulnerablePopulationSelected = true. Consent: "Must sign an ICF indicating that participant understands the purpose of, and procedures required for, the study and is willing to participate in the study. The ICF may be signed by an impartial witness and/or legally designated representative depending on national/local regulations." Country-specific ICFs and appendices (including privacy appendix for child and pregnant partner documents) are provided; assent procedures are not explicitly detailed in the provided criteria.
Inclusion criteria
- {"criterion_text":"- 1. Study participants who were enrolled and received treatment with JNJ-81201887 or sham in a parent clinical study.\n- 2. Must sign an ICF indicating that participant understands the purpose of, and procedures required for, the study and is willing to participate in the study. The ICF may be signed by an impartial witness and/or legally designated representative depending on national/local regulations."}
Exclusion criteria
- {"criterion_text":"- NA, LTE study"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Ocular and systemic treatment-emergent adverse events.","definition_or_measurement_approach":""}
- {"endpoint_text":"- Clinical laboratory and safety assessments.","definition_or_measurement_approach":""}
- {"endpoint_text":"- Retinal imaging (FAF, SD-OCT, and CFP) and eye examinations.","definition_or_measurement_approach":"Retinal imaging modalities listed: FAF, SD-OCT, and CFP."}
Recruitment
- Planned Sample Size
- 182
- Recruitment Window Months
- 54
- Consent Approach
- Participants must sign an ICF indicating understanding of study purpose and procedures; the ICF may be signed by an impartial witness and/or legally designated representative depending on national/local regulations. Country-specific ICFs and appendices are provided in multiple languages (examples in submission: Dutch, French, Spanish, Italian, German, Portuguese, Czech, Polish, Swedish, Hungarian, English). Privacy appendices for child and pregnant partner are available in some country documents; assent procedures are not explicitly detailed in the available summary.
Geography
- Total Number Of Sites
- 44
- Total Number Of Participants
- 120
Belgium
- Earliest CTIS Part Ii Submission Date
- 18-10-2024
- Latest Decision Or Authorization Date
- 14-04-2025
- Processing Time Days
- 178
- Number Of Sites
- 3
- Number Of Participants
- 3
Sites
- Site Name
- Universiteit Gent
- Department Name
- Department of Ophthalmology
- Principal Investigator Name
- Julie De Zaeytijd
- Principal Investigator Email
- julie.dezaeytijd@ugent.be
- Contact Person Name
- Julie De Zaeytijd
- Contact Person Email
- julie.dezaeytijd@ugent.be
- Site Name
- UZ Leuven
- Department Name
- Department of Ophthalmology
- 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
- Ziekenhuis Oost Limburg
- Department Name
- Department of Ophthalmology
- Principal Investigator Name
- Catherine Deghislage
- Principal Investigator Email
- catherine.deghislage@zol.be
- Contact Person Name
- Catherine Deghislage
- Contact Person Email
- catherine.deghislage@zol.be
Czechia
- Earliest CTIS Part Ii Submission Date
- 21-08-2024
- Latest Decision Or Authorization Date
- 15-04-2025
- Processing Time Days
- 237
- Number Of Sites
- 2
- Number Of Participants
- 10
Sites
- Site Name
- Axon Clinical s.r.o.
- 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
- Fakultni Nemocnice Kralovske Vinohrady
- Department Name
- Vitreoretinální oddělení a makulární centrum
- Principal Investigator Name
- Miroslav Veith
- Principal Investigator Email
- miroslav.veith@fnkv.cz
- Contact Person Name
- Miroslav Veith
- Contact Person Email
- miroslav.veith@fnkv.cz
Spain
- Earliest CTIS Part Ii Submission Date
- 18-10-2024
- Latest Decision Or Authorization Date
- 14-04-2025
- Processing Time Days
- 178
- Number Of Sites
- 13
- Number Of Participants
- 45
Sites
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Servicio de oftalmologia
- Principal Investigator Name
- Almudena de Pablo
- Principal Investigator Email
- almu.depablo@gmail.com
- Contact Person Name
- Almudena de Pablo
- Contact Person Email
- almu.depablo@gmail.com
- Site Name
- Hospital Universitario Puerta De Hierro De Majadahonda
- Department Name
- Servicio de Oftalmologia
- Principal Investigator Name
- Jose Maria Ruiz
- Principal Investigator Email
- josemaria.ruiz@uclm.es
- Contact Person Name
- Jose Maria Ruiz
- Contact Person Email
- josemaria.ruiz@uclm.es
- Site Name
- Centro Medico Teknon-Grupo Quironsalud
- Principal Investigator Name
- Jordi Mones
- Principal Investigator Email
- jmones@institutmacula.com
- Contact Person Name
- Jordi Mones
- Contact Person Email
- jmones@institutmacula.com
- Site Name
- Clinica De Oftalmologia De Cordoba S.L.
- Principal Investigator Name
- Juan Manuel Cubero
- Principal Investigator Email
- jmcubero@hospitalarruzafa.com
- Contact Person Name
- Juan Manuel Cubero
- Contact Person Email
- jmcubero@hospitalarruzafa.com
- Site Name
- Hospital Clinico Universitario Lozano Blesa
- Department Name
- Servicio de Oftalmologia
- Principal Investigator Name
- Javier Ascaso
- Principal Investigator Email
- jascaso@gmail.com
- Contact Person Name
- Javier Ascaso
- Contact Person Email
- jascaso@gmail.com
- Site Name
- Clinica Baviera S.A.
- Department Name
- Servicio de Oftalmologia
- Principal Investigator Name
- Marta S. Figueroa
- Principal Investigator Email
- figueroa.marta@outlook.es
- Contact Person Name
- Marta S. Figueroa
- Contact Person Email
- figueroa.marta@outlook.es
- Site Name
- Centro De Oftalmologia Barraquer S.A.
- Principal Investigator Name
- Santiago Abengoechea
- Principal Investigator Email
- sah@barraquer.com
- Contact Person Name
- Santiago Abengoechea
- Contact Person Email
- sah@barraquer.com
- Site Name
- Hospital Universitari General De Catalunya
- Department Name
- Servicio de Oftalmologia
- Principal Investigator Name
- Laura Sararols
- Principal Investigator Email
- sararols.laura@hotmail.com
- Contact Person Name
- Laura Sararols
- Contact Person Email
- sararols.laura@hotmail.com
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Servicio de Oftalmologia
- Principal Investigator Name
- Nelida Muñoz Sanz
- Principal Investigator Email
- nelychan27@gmail.com
- Contact Person Name
- Nelida Muñoz Sanz
- Contact Person Email
- nelychan27@gmail.com
- Site Name
- Oftalmologia Vistahermosa S.L.
- Principal Investigator Name
- Roberto Gallego-Pinazo
- Principal Investigator Email
- robertogallegopinazo@gmail.com
- Contact Person Name
- Roberto Gallego-Pinazo
- Contact Person Email
- robertogallegopinazo@gmail.com
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- Servicio de Oftalmologia
- Principal Investigator Name
- Andres Romero
- Principal Investigator Email
- andresromero_martinez@hotmail.es
- Contact Person Name
- Andres Romero
- Contact Person Email
- andresromero_martinez@hotmail.es
- Site Name
- Clinica Universidad De Navarra
- Department Name
- Servicio de Oftalmologia
- Principal Investigator Name
- Alfredo Garcia Ayana
- Principal Investigator Email
- aglayana@unav.es
- Contact Person Name
- Alfredo Garcia Ayana
- Contact Person Email
- aglayana@unav.es
- Site Name
- Institut Catala De Retina S.L.
- Principal Investigator Name
- Ignasi Jurgens
- Principal Investigator Email
- jurgens@comb.cat
- Contact Person Name
- Ignasi Jurgens
- Contact Person Email
- jurgens@comb.cat
Netherlands
- Earliest CTIS Part Ii Submission Date
- 22-10-2024
- Latest Decision Or Authorization Date
- 11-04-2025
- Processing Time Days
- 171
- Number Of Sites
- 2
- Number Of Participants
- 2
Sites
- Site Name
- The Rotterdam Eye Hospital
- Principal Investigator Name
- Ingeborg van den Born
- Principal Investigator Email
- born@oogziekenhuis.nl
- Contact Person Name
- Ingeborg van den Born
- Contact Person Email
- born@oogziekenhuis.nl
- Site Name
- Stichting Radboud universitair medisch centrum
- Department Name
- Department of Ophthalmology
- Principal Investigator Name
- Yara Lechanteur
- Principal Investigator Email
- yara.lechanteur@radboudumc.nl
- Contact Person Name
- Yara Lechanteur
- Contact Person Email
- yara.lechanteur@radboudumc.nl
Germany
- Earliest CTIS Part Ii Submission Date
- 11-10-2024
- Latest Decision Or Authorization Date
- 04-06-2025
- Processing Time Days
- 236
- Number Of Sites
- 8
- Number Of Participants
- 22
Sites
- Site Name
- Universitaetsklinikum Tuebingen AöR
- Principal Investigator Name
- Lisa Strudel
- Principal Investigator Email
- lisa.strudel@med.uni-tuebingen.de
- Contact Person Name
- Lisa Strudel
- Contact Person Email
- lisa.strudel@med.uni-tuebingen.de
- Site Name
- Medizinische Hochschule Hannover
- Principal Investigator Name
- Carsten Framme
- Principal Investigator Email
- Framme.Carsten@mh-hannover.de
- Contact Person Name
- Carsten Framme
- Contact Person Email
- Framme.Carsten@mh-hannover.de
- Site Name
- Klinikum der Stadt Ludwigshafen am Rhein gGmbH
- Principal Investigator Name
- Lars-Olof Hattenbach
- Principal Investigator Email
- Hattenbach.LO@klilu.de
- Contact Person Name
- Lars-Olof Hattenbach
- Contact Person Email
- Hattenbach.LO@klilu.de
- Site Name
- Augenzentrum Am St Franziskus-Hospital Muenster
- Department Name
- Augenzentrum am St Franziskus-Hospital Münster
- Principal Investigator Name
- Georg Spital
- Principal Investigator Email
- georg.spital@augen-franziskus.de
- Contact Person Name
- Georg Spital
- Contact Person Email
- georg.spital@augen-franziskus.de
- Site Name
- Universitaet Leipzig
- Principal Investigator Name
- Focke Ziemssen
- Principal Investigator Email
- Focke.ziemssen@medizin.uni-leipzig.de
- Contact Person Name
- Focke Ziemssen
- Contact Person Email
- Focke.ziemssen@medizin.uni-leipzig.de
- Site Name
- Universitaetsmedizin Goettingen
- Principal Investigator Name
- Sebastian Bemme
- Principal Investigator Email
- Sebastian.bemme@med.uni-goettingen.de
- Contact Person Name
- Sebastian Bemme
- Contact Person Email
- Sebastian.bemme@med.uni-goettingen.de
- Site Name
- Universitätsklinikum Bonn AöR
- Principal Investigator Name
- Kristina Pfau
- Principal Investigator Email
- Gamze.Bildik@ukbonn.de
- Contact Person Name
- Kristina Pfau
- Contact Person Email
- Gamze.Bildik@ukbonn.de
- Site Name
- Universitaetsklinikum Muenster AöR
- Department Name
- Klinik fuer Augenheilkunde
- Principal Investigator Name
- Nicole Eter
- Principal Investigator Email
- eter@uni-muenster.de
- Contact Person Name
- Nicole Eter
- Contact Person Email
- eter@uni-muenster.de
Portugal
- Earliest CTIS Part Ii Submission Date
- 08-10-2024
- Latest Decision Or Authorization Date
- 09-07-2025
- Processing Time Days
- 274
- Number Of Sites
- 3
- Number Of Participants
- 6
Sites
- Site Name
- Unidade Local De Saude De Coimbra E.P.E.
- Department Name
- Oftalmologia
- Principal Investigator Name
- Rufino Silva
- Principal Investigator Email
- rufino.silva@oftalmologia.co.pt
- Contact Person Name
- Rufino Silva
- Contact Person Email
- rufino.silva@oftalmologia.co.pt
- Site Name
- Unidade Local de Saude de Sao Joao E.P.E.
- Department Name
- Oftalmologia
- Principal Investigator Name
- Angela Carneiro
- Principal Investigator Email
- amvgcarneiro@gmail.com
- Contact Person Name
- Angela Carneiro
- Contact Person Email
- amvgcarneiro@gmail.com
- Site Name
- Rufino Silva & Joao Figueira Espaco Medico De Coimbra Lda.
- Department Name
- Oftalmologia
- Principal Investigator Name
- Joao Figueira
- Principal Investigator Email
- joaofigueira@oftalmologia.co.pt
- Contact Person Name
- Joao Figueira
- Contact Person Email
- joaofigueira@oftalmologia.co.pt
Sweden
- Earliest CTIS Part Ii Submission Date
- 21-08-2024
- Latest Decision Or Authorization Date
- 27-06-2025
- Processing Time Days
- 310
- Number Of Sites
- 1
- Number Of Participants
- 1
Sites
- Site Name
- St Erik Eye Hospital
- Department Name
- Retinamottagningen
- Principal Investigator Name
- Anders Kvanta
- Principal Investigator Email
- anders.kvanta@ki.se
- Contact Person Name
- Anders Kvanta
- Contact Person Email
- anders.kvanta@ki.se
Denmark
- Earliest CTIS Part Ii Submission Date
- 30-10-2024
- Latest Decision Or Authorization Date
- 12-06-2025
- Processing Time Days
- 225
- Number Of Sites
- 1
- Number Of Participants
- 6
Sites
- Site Name
- Rigshospitalet
- Department Name
- HovedOrtoCentret – Afdeling for Øjensygdomme, Afsnit 37
- Principal Investigator Name
- Michael Larsen
- Principal Investigator Email
- lars.michael.larsen@regionh.dk
- Contact Person Name
- Michael Larsen
- Contact Person Email
- lars.michael.larsen@regionh.dk
Poland
- Earliest CTIS Part Ii Submission Date
- 18-10-2024
- Latest Decision Or Authorization Date
- 24-07-2025
- Processing Time Days
- 279
- Number Of Sites
- 2
- Number Of Participants
- 9
Sites
- Site Name
- Warszawski Szpital Okulistyczny Sp. z o.o.
- Principal Investigator Name
- Agnieszka Nowosielska
- Principal Investigator Email
- nowosielska.aga@gmail.com
- Contact Person Name
- Agnieszka Nowosielska
- Contact Person Email
- nowosielska.aga@gmail.com
- Site Name
- Oftalmika Sp. z o.o.
- Principal Investigator Name
- Jakub Kaluzny
- Principal Investigator Email
- jjkaluzny@oftalmika.pl
- Contact Person Name
- Jakub Kaluzny
- Contact Person Email
- jjkaluzny@oftalmika.pl
Italy
- Earliest CTIS Part Ii Submission Date
- 21-10-2024
- Latest Decision Or Authorization Date
- 25-08-2025
- Processing Time Days
- 308
- Number Of Sites
- 6
- Number Of Participants
- 10
Sites
- Site Name
- Ospedale San Raffaele S.r.l.
- Department Name
- Unità di Oculistica
- Principal Investigator Name
- Francesco Bandello
- Principal Investigator Email
- bandello.francesco@hsr.it
- Contact Person Name
- Francesco Bandello
- Contact Person Email
- bandello.francesco@hsr.it
- Site Name
- Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
- Department Name
- U.O.C. Clinica Oculistica
- Principal Investigator Name
- Francesca Simonelli
- Principal Investigator Email
- francesca.simonelli@unicampania.it
- Contact Person Name
- Francesca Simonelli
- Contact Person Email
- francesca.simonelli@unicampania.it
- Site Name
- ASST Fatebenefratelli Sacco
- Department Name
- Clinica Oculistica
- Principal Investigator Name
- Giovanni Staurenghi
- Principal Investigator Email
- giovanni.staurenghi@unimi.it
- Contact Person Name
- Giovanni Staurenghi
- Contact Person Email
- giovanni.staurenghi@unimi.it
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- Unità Operativa Complessa Oculistica
- Principal Investigator Name
- Stanislao Rizzo
- Principal Investigator Email
- stanislao.rizzo@policlinicogemelli.it
- Contact Person Name
- Stanislao Rizzo
- Contact Person Email
- stanislao.rizzo@policlinicogemelli.it
- Site Name
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
- Department Name
- Malattie Apparato Visivo
- 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
- University Hospital Of Ferrara
- Department Name
- Unità Operativa Complessa di clinical oculistica
- Principal Investigator Name
- Francesco Parmeggiani
- Principal Investigator Email
- prmfnc@unife.it
- Contact Person Name
- Francesco Parmeggiani
- Contact Person Email
- prmfnc@unife.it
Hungary
- Earliest CTIS Part Ii Submission Date
- 27-09-2024
- Latest Decision Or Authorization Date
- 19-08-2025
- Processing Time Days
- 326
- Number Of Sites
- 3
- Number Of Participants
- 6
Sites
- Site Name
- Central Hospital Of Northern Pest Military Hospital
- Department Name
- Szemészeti Osztály
- Principal Investigator Name
- Gabor Vogt
- Principal Investigator Email
- gabor.vogt@tosho.hu
- Contact Person Name
- Gabor Vogt
- Contact Person Email
- gabor.vogt@tosho.hu
- Site Name
- Zala Varmegyei Szent Rafael Korhaz
- Principal Investigator Name
- Etelka Aradi
- Principal Investigator Email
- etaaradi@gmail.com
- Contact Person Name
- Etelka Aradi
- Contact Person Email
- etaaradi@gmail.com
- Site Name
- Nozologen Kft.
- Principal Investigator Name
- Balazs Varsanyi
- Principal Investigator Email
- varsanyi.balazs@gmail.com
- Contact Person Name
- Balazs Varsanyi
- Contact Person Email
- varsanyi.balazs@gmail.com
Sponsor
Primary sponsor
- Full Name
- Janssen - Cilag International
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Belgium
Third parties
- {"country":"United States","full_name":"Boston Image Reading Center LLC","duties_or_roles":"Providing central Imaging reader services","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Optymedge LLC","duties_or_roles":"BCVA Lane equipment vendor","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Fisher Clinical Services Inc.","duties_or_roles":"Ancillary supply vendor","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Labcorp Drug Development Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Labconnect LLC","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
Investigational products
- Investigational Product Name
- JNJ-81201887
- Active Substance
- Adeno-associated virus serotype 2 encoding soluble CD59
- Modality
- Gene therapy
- Routes Of Administration
- Intravitreal use
- Route
- Intravitreal
- Investigational Product Name
- Prednison acis 20 mg, Tabletten
- Active Substance
- Prednisone
- Modality
- Small molecule
- Routes Of Administration
- Oral use
- Route
- Oral
- Starting Dose
- 20 mg
- Dose Levels
- 20 mg
- Investigational Product Name
- Prednison acis 5 mg, Tabletten
- Active Substance
- Prednisone
- Modality
- Small molecule
- Routes Of Administration
- Oral use
- Route
- Oral
- Starting Dose
- 5 mg
- Dose Levels
- 5 mg
- Investigational Product Name
- Kenacort-A 40, suspensie voor injectie 40 mg/ml
- Active Substance
- Triamcinolone acetonide
- Modality
- Small molecule
- Routes Of Administration
- Ocular use
- Route
- Ocular
- Dose Levels
- 40 mg/ml
- Investigational Product Name
- Placebo to match Prednisone 20mg, 5mg
- Modality
- Other
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