En langsigtet forlængelsesundersøgelse af JNJ-81201887 (AAVCAGsCD59) forældreundersøgelser i deltagere med geografisk atrofi (GA) sekundær til aldersrelateret makuladegeneration (AMD)
2. november 2026 opdateret af: Janssen Research & Development, LLC
Langsigtet forlængelsesundersøgelse for deltagere med geografisk atrofi (GA) sekundær til aldersrelateret makuladegeneration (AMD) i JNJ-81201887 kliniske forældreundersøgelser
The purpose of this study is to assess the long-term safety and tolerability after an intravitreal injection (a shot of medicine into the eye) of JNJ-81201887 administered in parent clinical studies.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
274
Fase
- Fase 2
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Study Contact
- Telefonnummer: 844-434-4210
- E-mail: Participate-In-This-Study1@its.jnj.com
Studiesteder
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East Melbourne, Australien, 3002
- Rekruttering
- Centre for Eye Research Australia
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Strathfield, Australien, 2135
- Rekruttering
- Strathfield Retina Clinic
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Sydney, Australien, 2000
- Rekruttering
- Sydney Retina Clinic and Day Surgery
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Westmead, Australien, 2145
- Rekruttering
- Sydney West Retina
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Genk, Belgien, 3600
- Aktiv, ikke rekrutterende
- Ziekenhuis Oost-Limburg
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Ghent, Belgien, 9000
- Aktiv, ikke rekrutterende
- UZ Gent
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Leuven, Belgien, 3000
- Aktiv, ikke rekrutterende
- UZ Leuven Gasthuisberg
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Alberta
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Edmonton, Alberta, Canada, T5H 0X5
- Afsluttet
- Alberta Retina Consultants
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Glostrup Municipality, Danmark, 2600
- Aktiv, ikke rekrutterende
- University Hospital Of Copenhagen, Glostrup Hospital
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Bristol, Det Forenede Kongerige, BS1 2LX
- Aktiv, ikke rekrutterende
- Bristol Eye Hospital
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Headington, Det Forenede Kongerige, OX3 9DU
- Aktiv, ikke rekrutterende
- Oxford Eye Hospital
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London, Det Forenede Kongerige, W1G 9AX
- Aktiv, ikke rekrutterende
- The Retina Clinic London
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Newcastle upon Tyne, Det Forenede Kongerige, NE1 4LP
- Afsluttet
- Royal Victoria Infirmary
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Arizona
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Tucson, Arizona, Forenede Stater, 85704
- Rekruttering
- Retina Associates Southwest PC
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California
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Fullerton, California, Forenede Stater, 92835
- Rekruttering
- Retina Consultants of Orange County
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La Jolla, California, Forenede Stater, 92093 0946
- Rekruttering
- Shiley Eye Institute Jacobs Retina Center
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Oxnard, California, Forenede Stater, 93036
- Rekruttering
- California Retina Consultants
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Pasadena, California, Forenede Stater, 91107
- Rekruttering
- California Eye Medical Specialists
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Poway, California, Forenede Stater, 92064
- Rekruttering
- Retina Consultants San Diego
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Walnut Creek, California, Forenede Stater, 94598
- Rekruttering
- Bay Area Retina Associates
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Florida
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Fort Lauderdale, Florida, Forenede Stater, 33308
- Rekruttering
- Retina Group of Florida
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Gainesville, Florida, Forenede Stater, 32607
- Rekruttering
- VitreoRetinal Associates, PA
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Pensacola, Florida, Forenede Stater, 32503
- Rekruttering
- Retina Specialty Institute
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St. Petersburg, Florida, Forenede Stater, 33711
- Rekruttering
- Retina Vitreous Associates of Florida
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Georgia
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Marietta, Georgia, Forenede Stater, 30060
- Rekruttering
- Georgia Retina
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Marietta, Georgia, Forenede Stater, 30060
- Rekruttering
- Marietta Eye Clinic
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Illinois
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Lemont, Illinois, Forenede Stater, 60439
- Rekruttering
- University Retina
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Indiana
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Carmel, Indiana, Forenede Stater, 46032
- Rekruttering
- Midwest Eye Institute
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Maine
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Portland, Maine, Forenede Stater, 04101
- Rekruttering
- Maine Eye Center
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Maryland
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Baltimore, Maryland, Forenede Stater, 21204
- Rekruttering
- Retina Specialists
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Chevy Chase, Maryland, Forenede Stater, 20815
- Rekruttering
- The Retina Group of Washington
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Hagerstown, Maryland, Forenede Stater, 21740
- Rekruttering
- Cumberland Valley Retina Consultants
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02114
- Rekruttering
- Ophthalmic Consultants of Boston
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Michigan
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Grand Rapids, Michigan, Forenede Stater, 49546
- Rekruttering
- Foundation for Vision Research
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Minnesota
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Saint Louis Park, Minnesota, Forenede Stater, 55416
- Rekruttering
- Retina Consultants of Minnesota
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Missouri
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St Louis, Missouri, Forenede Stater, 63128
- Rekruttering
- The Retina Institute
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Nevada
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Reno, Nevada, Forenede Stater, 89502
- Rekruttering
- Sierra Eye Associates
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New York
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Liverpool, New York, Forenede Stater, 13088
- Rekruttering
- Retina-Vitreous Surgeons of Central New York
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North Carolina
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Asheville, North Carolina, Forenede Stater, 28803
- Rekruttering
- Asheville Eye Associates - Western Carolina Retinal Associates
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Durham, North Carolina, Forenede Stater, 27705
- Rekruttering
- Duke Eye Center
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Hickory, North Carolina, Forenede Stater, 28602
- Rekruttering
- Graystone Eye
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Wake Forest, North Carolina, Forenede Stater, 27587
- Rekruttering
- NC Retina Associates
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Ohio
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Cincinnati, Ohio, Forenede Stater, 45242
- Rekruttering
- Cincinnati Eye Institute
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Cleveland, Ohio, Forenede Stater, 44195
- Rekruttering
- Cleveland Clinic Main Campus
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Oregon
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Eugene, Oregon, Forenede Stater, 97401
- Rekruttering
- Verum Research LLC
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Springfield, Oregon, Forenede Stater, 97477
- Rekruttering
- Cascade Medical Research Institute, LLC
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Pennsylvania
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Erie, Pennsylvania, Forenede Stater, 16505
- Rekruttering
- Erie Retina Research
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South Carolina
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Beaufort, South Carolina, Forenede Stater, 29902
- Rekruttering
- Charleston Neuroscience Institute, LLC
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Texas
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Austin, Texas, Forenede Stater, 78750
- Rekruttering
- Austin Clinical Research
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Dallas, Texas, Forenede Stater, 75390
- Rekruttering
- UT Southwestern Medical Center
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Dallas, Texas, Forenede Stater, 75231
- Rekruttering
- Texas Retina Associates
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San Antonio, Texas, Forenede Stater, 78240
- Rekruttering
- Retina Associates Of South Texas P A
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The Woodlands, Texas, Forenede Stater, 77384
- Rekruttering
- Retina Consultants of Texas
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Willow Park, Texas, Forenede Stater, 76087
- Rekruttering
- Strategic Clinical Research Group
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Utah
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Salt Lake City, Utah, Forenede Stater, 84132
- Rekruttering
- University of Utah
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Virginia
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Lynchburg, Virginia, Forenede Stater, 24502
- Rekruttering
- Piedmont Eye Center
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Norfolk, Virginia, Forenede Stater, 23502
- Rekruttering
- Wagner Kapoor Research institute
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Washington
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Spokane, Washington, Forenede Stater, 99204
- Rekruttering
- Spokane Eye Clinical Research
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Nijmegen, Holland, 6525 GA
- Aktiv, ikke rekrutterende
- Radboudumc
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Rotterdam, Holland, 3011
- Aktiv, ikke rekrutterende
- Het Oogziekenhuis Rotterdam
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Ferrara, Italien, 44124
- Rekruttering
- Azienda Ospedaliero Universitaria di Ferrara
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Milan, Italien, 20157
- Rekruttering
- ASST Fatebenefratelli Sacco
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Milan, Italien, 20122
- Rekruttering
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
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Milan, Italien, 20132
- Rekruttering
- IRCCS Ospedale San Raffaele
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Naples, Italien, 80138
- Rekruttering
- Azienda Ospedaliero Universitaria Luigi Vanvitelli
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Roma, Italien, 00168
- Rekruttering
- Fondazione Policlinico Universitario A Gemelli IRCCS
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Beijing, Kina, 100730
- Rekruttering
- Beijing Tongren Hospital CMU
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Chengdu, Kina, 610041
- Rekruttering
- West China Hospital Si Chuan University
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Shanghai, Kina, 200080
- Rekruttering
- Shanghai General Hospital
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Bydgoszcz, Polen, 85 631
- Aktiv, ikke rekrutterende
- Oftalmika
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Warsaw, Polen, 01 258
- Aktiv, ikke rekrutterende
- Warszawski Szpital Okulistyczny
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Coimbra, Portugal, 3000 075
- Aktiv, ikke rekrutterende
- Uls Coimbra - Hosp. Univ. Coimbra
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Coimbra, Portugal, 3030 163
- Aktiv, ikke rekrutterende
- Espaco Medico de Coimbra
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Porto, Portugal, 4200 319
- Aktiv, ikke rekrutterende
- Uls Sao Joao
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Bern, Schweiz, 3010
- Rekruttering
- Inselspital Universitatsspital Bern
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Barcelona, Spanien, 08021
- Rekruttering
- Centro de Oftalmologia Barraquer
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Barcelona, Spanien, 08022
- Rekruttering
- Centro Medico Teknon S.L.
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Barcelona, Spanien, 08022
- Rekruttering
- Inst. Cat. de Retina
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Burjassot, Spanien, 46100
- Rekruttering
- Clinica Oftalvist Valencia
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Córdoba, Spanien, 14012
- Rekruttering
- Hosp. La Arruzafa
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Madrid, Spanien, 28041
- Rekruttering
- Hosp. Univ. 12 de Octubre
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Madrid, Spanien, 28046
- Rekruttering
- Clinica Baviera Madrid Castellana
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Madrid, Spanien, 28040
- Rekruttering
- Hosp Univ Fund Jimenez Diaz
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Majadahonda, Spanien, 28222
- Rekruttering
- Hosp. Univ. Pta. de Hierro Majadahonda
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Pamplona, Spanien, 31008
- Rekruttering
- Clinica Univ. de Navarra
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Sant Cugat del Vallès, Spanien, 08195
- Rekruttering
- Idc Salud Hosp. Gral. de Catalunya
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Seville, Spanien, 41013
- Rekruttering
- Hosp. Virgen Del Rocio
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Zaragoza, Spanien, 50009
- Rekruttering
- Hosp. Clinico Univ. Lozano Blesa
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Stockholm, Sverige, 171 64
- Aktiv, ikke rekrutterende
- S:t Eriks Ogonsjukhus
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Prague, Tjekkiet, 15000
- Aktiv, ikke rekrutterende
- AXON Clinical s.r.o.
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Prague, Tjekkiet, 100 34
- Aktiv, ikke rekrutterende
- Fakultni nemocnice Kralovske Vinohrady
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Ankara, Tyrkiet (Türkiye), 06230
- Rekruttering
- Hacettepe University Medical Faculty
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Ankara, Tyrkiet (Türkiye), 06490
- Rekruttering
- Baskent University Ankara Hospital
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Izmir, Tyrkiet (Türkiye), 35330
- Rekruttering
- Dokuz Eylul University Medical Faculty
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Bonn, Tyskland, 53127
- Rekruttering
- Universitaets-Augenklinik Bonn
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Göttingen, Tyskland, 37075
- Rekruttering
- Klinikum Gottingen der Georg August Universitat
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Hanover, Tyskland, 30625
- Rekruttering
- Medizinische Hochschule Hannover
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Leipzig, Tyskland, 04103
- Rekruttering
- Universitaetsklinikum Leipzig
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Ludwigshafen am Rhein, Tyskland, 67063
- Rekruttering
- Klinikum Ludwigshafen
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Münster, Tyskland, 48145
- Rekruttering
- Augenzentrum am St Franziskus Hospital Munster
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Tübingen, Tyskland, 72076
- Rekruttering
- Universitaetsklinikum Tuebingen
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Budapest, Ungarn, 1062
- Rekruttering
- Eszak Pesti Centrumkorhaz Honvedkorhaz
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Pécs, Ungarn, 7621
- Rekruttering
- Ganglion Orvosi Központ
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Zalaegerszeg, Ungarn, 8900
- Rekruttering
- Zala Varmegyei Szent Rafael Korhaz
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
60 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Participants who were enrolled and received treatment with JNJ-81201887 or sham in a parent clinical study (81201887MDG2001, 81201887MDG1003)
- 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
Exclusion Criteria:
- There are no exclusion criteria for this LTE study
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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. |
No study intervention will be administered as part of this LTE study. |
|
Eksperimentel: 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. |
No study intervention will be administered as part of this LTE study. |
|
Sham-komparator: Arm C: Sham Procedure
Participants randomized to the sham arm in parent study 81201887MDG2001 (NCT05811351) will enter this LTE study. No intervention will be administered as part of this study. |
No study intervention will be administered as part of this LTE study. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of Participants with Ocular and Systemic Treatment-emergent Adverse Events (TEAEs)
Tidsramme: Upto 5 Years
|
Number of participants with ocular and systemic TEAEs will be reported. An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs are defined as any adverse event occurring at or after the administration of study intervention. |
Upto 5 Years
|
|
Number of Participants with Abnormal Findings in Clinical Laboratory Assessments
Tidsramme: Upto 5 Years
|
Number of participants with abnormal findings in clinical laboratory Assessments (including hematology and clinical chemistry) will be reported. |
Upto 5 Years
|
|
Number of Participants with Abnormal Findings in Retinal imaging and Eye Examinations
Tidsramme: Upto 5 Years
|
Number of participants with abnormal findings in retinal imaging (Fundus Autofluorescence, Spectral Domain Optical Coherence Tomography) and eye examinations will be reported. |
Upto 5 Years
|
|
Change from Baseline in Best Corrected Visual Acuity (BCVA) Using Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score
Tidsramme: Baseline up to 42 months
|
BCVA will be assessed using the ETDRS chart at a starting distance of 4 meters. The ETDRS score ranges from 0 to 100 letters, where an increase in the number of letters read correctly means that visual acuity has improved and vice-versa. |
Baseline up to 42 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Studieleder: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
19. september 2024
Primær færdiggørelse (Anslået)
24. august 2029
Studieafslutning (Anslået)
16. juli 2030
Datoer for studieregistrering
Først indsendt
23. september 2024
Først indsendt, der opfyldte QC-kriterier
9. oktober 2024
Først opslået (Faktiske)
10. oktober 2024
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
3. november 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
2. november 2026
Sidst verificeret
1. november 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 81201887MDG3002
- 2022-500747-21-00 (Registry Identifier: EUCT number)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
The data sharing policy of Johnson & Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .