A Long-term Extension Study of JNJ-81201887 (AAVCAGsCD59) Parent Studies in Participants With Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD)
NCT ID: NCT06635148
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
311 participants
INTERVENTIONAL
2024-09-19
2030-06-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Arm A: JNJ-81201887 Low Dose
Study participants who were enrolled and received treatment with low dose JNJ-81201887 in parent clinical studies (81201887MDG2001 \[NCT05811351\]; 81201887MDG1003) will enter this long-term extension (LTE) study. No study intervention will be administered as part of this study.
JNJ-81201887
No study intervention will be administered as part of this LTE study.
Arm B: JNJ-81201887 High dose
Study participants who were enrolled and received treatment with high dose JNJ-81201887 in parent clinical studies (81201887MDG2001 \[NCT05811351\]; 81201887MDG1003) will enter this LTE study. No study intervention will be administered as part of this study.
JNJ-81201887
No study intervention will be administered as part of this LTE study.
Arm C: Sham Procedure
Participants randomized to the sham arm in parent study 81201887MDG2001 (NCT05811351) may have the option to receive JNJ-81201887 open-label treatment under a separate protocol after unmasking of that study; and will enter this LTE study. No intervention will be administered as part of this study.
Sham Procedure
No study intervention will be administered as part of this LTE study.
Interventions
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JNJ-81201887
No study intervention will be administered as part of this LTE study.
Sham Procedure
No study intervention will be administered as part of this LTE study.
Eligibility Criteria
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Inclusion Criteria
* Females (women of childbearing potential), male participants, and partners of male participants will not be required to use contraception in this LTE study
* Must sign an informed consent form (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
60 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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Retina Associates Southwest PC
Tucson, Arizona, United States
Retina Consultants of Orange County
Fullerton, California, United States
Shiley Eye Institute Jacobs Retina Center
La Jolla, California, United States
California Retina Consultants
Oxnard, California, United States
California Eye Medical Specialists
Pasadena, California, United States
Retina Consultants San Diego
Poway, California, United States
Bay Area Retina Associates
Walnut Creek, California, United States
Retina Group of Florida
Fort Lauderdale, Florida, United States
VitreoRetinal Associates, PA
Gainesville, Florida, United States
Retina Specialty Institute
Pensacola, Florida, United States
Retina Vitreous Associates of Florida
St. Petersburg, Florida, United States
Georgia Retina
Marietta, Georgia, United States
Marietta Eye Clinic
Marietta, Georgia, United States
University Retina
Lemont, Illinois, United States
Midwest Eye Institute
Carmel, Indiana, United States
Maine Eye Center
Portland, Maine, United States
Retina Specialists
Baltimore, Maryland, United States
The Retina Group of Washington
Chevy Chase, Maryland, United States
Cumberland Valley Retina Consultants
Hagerstown, Maryland, United States
Ophthalmic Consultants of Boston
Boston, Massachusetts, United States
Foundation for Vision Research
Grand Rapids, Michigan, United States
Retina Consultants of Minnesota
Saint Louis Park, Minnesota, United States
The Retina Institute
St Louis, Missouri, United States
Sierra Eye Associates
Reno, Nevada, United States
Retina-Vitreous Surgeons of Central New York
Liverpool, New York, United States
Asheville Eye Associates - Western Carolina Retinal Associates
Asheville, North Carolina, United States
Duke Eye Center
Durham, North Carolina, United States
Graystone Eye
Hickory, North Carolina, United States
NC Retina Associates
Wake Forest, North Carolina, United States
Cincinnati Eye Institute
Cincinnati, Ohio, United States
Verum Research LLC
Eugene, Oregon, United States
Cascade Medical Research Institute, LLC
Springfield, Oregon, United States
Erie Retina Research
Erie, Pennsylvania, United States
Charleston Neuroscience Institute, LLC
Beaufort, South Carolina, United States
Austin Clinical Research
Austin, Texas, United States
Retina and Vitreous of Texas, PLLC
Bellaire, Texas, United States
Texas Retina Associates
Dallas, Texas, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Retina Associates Of South Texas P A
San Antonio, Texas, United States
Retina Consultants of Texas
The Woodlands, Texas, United States
Strategic Clinical Research Group
Willow Park, Texas, United States
University of Utah
Salt Lake City, Utah, United States
Piedmont Eye Center
Lynchburg, Virginia, United States
Wagner Kapoor Research institute
Norfolk, Virginia, United States
Spokane Eye Clinical Research
Spokane, Washington, United States
Centre for Eye Research Australia
East Melbourne, , Australia
Strathfield Retina Clinic
Strathfield, , Australia
Sydney West Retina
Westmead, , Australia
Ziekenhuis Oost-Limburg
Genk, , Belgium
UZ Gent
Ghent, , Belgium
UZ Leuven Gasthuisberg
Leuven, , Belgium
Alberta Retina Consultants
Edmonton, Alberta, Canada
Beijing Tongren Hospital CMU
Beijing, , China
Shanghai General Hospital
Shanghai, , China
Fakultni nemocnice Kralovske Vinohrady
Prague, , Czechia
AXON Clinical s.r.o.
Prague, , Czechia
University Hospital Of Copenhagen, Glostrup Hospital
Glostrup Municipality, , Denmark
Universitaets-Augenklinik Bonn
Bonn, , Germany
Klinikum Gottingen der Georg August Universitat
Göttingen, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Universitaetsklinikum Leipzig
Leipzig, , Germany
Klinikum Ludwigshafen
Ludwigshafen am Rhein, , Germany
Augenzentrum am St Franziskus Hospital Munster
Münster, , Germany
Universitaetsklinikum Tuebingen
Tübingen, , Germany
Eszak Pesti Centrumkorhaz Honvedkorhaz
Budapest, , Hungary
Ganglion Orvosi Központ
Pécs, , Hungary
Zala Varmegyei Szent Rafael Korhaz
Zalaegerszeg, , Hungary
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milan, , Italy
IRCCS Ospedale San Raffaele
Milan, , Italy
Azienda Ospedaliero Universitaria Luigi Vanvitelli
Napoli, , Italy
Fondazione Policlinico Universitario A Gemelli IRCCS
Roma, , Italy
Radboudumc
Nijmegen, , Netherlands
Het Oogziekenhuis Rotterdam
Rotterdam, , Netherlands
Oftalmika
Bydgoszcz, , Poland
Warszawski Szpital Okulistyczny
Warsaw, , Poland
Uls Coimbra - Hosp. Univ. Coimbra
Coimbra, , Portugal
Espaco Medico de Coimbra
Coimbra, , Portugal
Uls Sao Joao
Porto, , Portugal
Centro de Oftalmologia Barraquer
Barcelona, , Spain
Centro Medico Teknon S.L.
Barcelona, , Spain
Inst. Cat. de Retina
Barcelona, , Spain
Clinica Oftalvist Valencia
Burjassot, , Spain
Hosp. La Arruzafa
Córdoba, , Spain
Hosp Univ Fund Jimenez Diaz
Madrid, , Spain
Hosp. Univ. 12 de Octubre
Madrid, , Spain
Clinica Baviera Madrid Castellana
Madrid, , Spain
Hosp. Univ. Pta. de Hierro Majadahonda
Majadahonda, , Spain
Clinica Univ. de Navarra
Pamplona, , Spain
Idc Salud Hosp. Gral. de Catalunya
Sant Cugat del Vallès, , Spain
Hosp. Virgen Del Rocio
Seville, , Spain
Hosp. Clinico Univ. Lozano Blesa
Zaragoza, , Spain
S:t Eriks Ogonsjukhus
Stockholm, , Sweden
Inselspital Universitatsspital Bern
Bern, , Switzerland
Hacettepe University Medical Faculty
Ankara, , Turkey (Türkiye)
Baskent University Ankara Hospital
Ankara, , Turkey (Türkiye)
Bristol Eye Hospital
Bristol, , United Kingdom
Oxford Eye Hospital
Headington, , United Kingdom
The Retina Clinic London
London, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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81201887MDG3002
Identifier Type: OTHER
Identifier Source: secondary_id
2022-500747-21-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
81201887MDG3002
Identifier Type: -
Identifier Source: org_study_id