En undersøgelse, der undersøger effektiviteten og sikkerheden af Intravitreal (IVT) injektioner af ANX007 hos deltagere med geografisk atrofi (GA) (ARCHER II)
2. oktober 2026 opdateret af: Annexon, Inc.
En fase 3, multicenter, randomiseret, parallel-gruppe, dobbeltmasket, 2-arm, sham kontrolleret undersøgelse af effektivitet, sikkerhed og tolerabilitet af ANX007 administreret ved intravitreal injektion hos patienter med geografisk atrofi (GA) sekundært til aldersrelateret makulær Degeneration (AMD)
The primary purpose of the study is to determine if IVT injections of vonaprument every month reduce vision loss in participants with dry AMD with GA.
Studieoversigt
Status
Aktiv, ikke rekrutterende
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
659
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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New South Wales
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Albury, New South Wales, Australien, 2640
- Eye Clinic Albury Wodonga
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Parramatta, New South Wales, Australien, 2150
- Marsden Eye Specialists
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Strathfield, New South Wales, Australien, 2135
- Strathfield Retina Clinic
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Sydney, New South Wales, Australien, 2000
- Sydney Eye Hospital
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Sydney, New South Wales, Australien, 2000
- Sydney Retina Clinic and Day Surgery
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Alberta
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Calgary, Alberta, Canada, T2H 0C8
- Calgary Retina Consultants
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Edmonton, Alberta, Canada, T5H 0X5
- Alberta Retina Consultants
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Ontario
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London, Ontario, Canada, N6A 4V2
- Ivey Eye Institute
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Ottawa, Ontario, Canada, K2B 7E9
- Retina Centre of Ottawa
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London, Det Forenede Kongerige, SE5 9RS
- King's College Hospital
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London, Det Forenede Kongerige, W1G 9AX
- The Retina Clinic London
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London
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Greater London, London, Det Forenede Kongerige, EC1V 2PD
- Moorfields Eye Hospital NHS foundation Trust
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Arizona
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Scottsdale, Arizona, Forenede Stater, 85255
- Retina Macula Institute of Arizona
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California
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Beverly Hills, California, Forenede Stater, 90211
- Retina-Vitreous Associates Medical Group
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Fullerton, California, Forenede Stater, 92835
- Retinal Consultants of Orange County Clinical Research Institute Inc
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Glendale, California, Forenede Stater, 91204
- Global Research Management
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Modesto, California, Forenede Stater, 95356
- Retina Consultants Medical Group
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Mountain View, California, Forenede Stater, 94040
- Northern California Retina Vitreous Associates Medical Group, Inc.
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Sacramento, California, Forenede Stater, 95825
- Retinal Consultants Medical Group
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Torrance, California, Forenede Stater, 90503
- Macula Retina Vitreous Research Institute
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Walnut Creek, California, Forenede Stater, 94598
- Bay Area Retina Associates
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Colorado
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Colorado Springs, Colorado, Forenede Stater, 80909
- Retina Consultants of Southern Colorado PC
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Denver, Colorado, Forenede Stater, 80222
- RSC Research, LLC
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Florida
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Deerfield Beach, Florida, Forenede Stater, 33064
- Rand Eye Institute
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Fort Myers, Florida, Forenede Stater, 33912
- National Ophthalmic Research Institute
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Orlando, Florida, Forenede Stater, 32806
- Florida Retina Institute
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Plantation, Florida, Forenede Stater, 33324
- Fort Lauderdale Eye Institute
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Sarasota, Florida, Forenede Stater, 34232
- Retina Group of Florida
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St. Petersburg, Florida, Forenede Stater, 33711
- Retina Vitreous Associates of Florida
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Stuart, Florida, Forenede Stater, 34994
- East Florida Eye Institute
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Tampa, Florida, Forenede Stater, 33609
- Retina Associates of Florida
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Georgia
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Marietta, Georgia, Forenede Stater, 30060
- Georgia Retina PC
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Hawaii
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‘Aiea, Hawaii, Forenede Stater, 96701
- Retina Consultants of Hawaii
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Illinois
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Elmhurst, Illinois, Forenede Stater, 60126
- Retina Associates Ltd
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Oak Forest, Illinois, Forenede Stater, 60452
- University Retina
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Springfield, Illinois, Forenede Stater, 62703
- Springfield Clinic LLP
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Iowa
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West Des Moines, Iowa, Forenede Stater, 50266
- Wolfe Eye Clinic
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Maine
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Portland, Maine, Forenede Stater, 04101
- Maine Eye Center
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Maryland
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Chevy Chase, Maryland, Forenede Stater, 20815
- Retina Group of Washington
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Hagerstown, Maryland, Forenede Stater, 21740
- Cumberland Valley Retina Consultants
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Hagerstown, Maryland, Forenede Stater, 21740
- Mid Atlantic Retina Specialists
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02114
- Ophthalmic Consultants of Boston
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Springfield, Massachusetts, Forenede Stater, 01107
- Retina Research Institute at New England Retina Consultants
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Minnesota
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Saint Louis Park, Minnesota, Forenede Stater, 55416
- Retina Consultants of Minnesota
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Nevada
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Reno, Nevada, Forenede Stater, 89502
- Sierra Eye Associates
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New Jersey
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Bloomfield, New Jersey, Forenede Stater, 07003
- Envision Ocular, LLC
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Cherry Hill, New Jersey, Forenede Stater, 08054
- Mid Atlantic Retina New Jersey
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New Mexico
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Albuquerque, New Mexico, Forenede Stater, 87109
- Vision Research Center Eye Associates of New Mexico
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New York
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Hauppauge, New York, Forenede Stater, 11788
- Long Island Vitreoretinal Consultants
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North Carolina
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Asheville, North Carolina, Forenede Stater, 28803
- Asheville Eye Associates - Retina Division
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Cary, North Carolina, Forenede Stater, 27511
- North Carolina Retina Associates
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Wake Forest, North Carolina, Forenede Stater, 27587
- North Carolina Retina Associates
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Winston-Salem, North Carolina, Forenede Stater, 27103
- Piedmont Retina Specialists
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Ohio
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Cleveland, Ohio, Forenede Stater, 44106
- University Hospitals Cleveland Medical Center
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Oklahoma
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Edmond, Oklahoma, Forenede Stater, 73013
- Retina Vitreous Center
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Tulsa, Oklahoma, Forenede Stater, 74114
- Tulsa Retina Consultants
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Oregon
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Eugene, Oregon, Forenede Stater, 97401
- Verum Research, LLC
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Portland, Oregon, Forenede Stater, 97209
- Eyehealth Northwest Portland
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Springfield, Oregon, Forenede Stater, 97477
- Cascade Medical Research Institute
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Pennsylvania
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Erie, Pennsylvania, Forenede Stater, 16507
- Erie Retina Research, LLC
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Kingston, Pennsylvania, Forenede Stater, 18704
- Eye Care Specialists
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South Carolina
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Aiken, South Carolina, Forenede Stater, 29802
- Palmetto Retina Center
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Beaufort, South Carolina, Forenede Stater, 29901
- Retina Consultants of Charleston
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Charleston, South Carolina, Forenede Stater, 29414
- Charleston Neuroscience Center
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Tennessee
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Johnson City, Tennessee, Forenede Stater, 37604
- Southeastern Retina Associates
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Texas
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Abilene, Texas, Forenede Stater, 79606
- Retina Research Institute of Texas
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Amarillo, Texas, Forenede Stater, 79106
- Southwest Retina Specialists
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Arlington, Texas, Forenede Stater, 76012
- Texas Retina Associates- Arlington
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Austin, Texas, Forenede Stater, 78705
- Austin Retina Associates
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Austin, Texas, Forenede Stater, 78705
- Austin Research Center for Retina
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Austin, Texas, Forenede Stater, 78750
- Austin Clinical Research, LLC
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Bellaire, Texas, Forenede Stater, 77401
- Retina Consultants of Texas
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Dallas, Texas, Forenede Stater, 75231
- Texas Retina Associates
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Dallas, Texas, Forenede Stater, 75231
- Retina Foundation of the Southwest
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Fort Worth, Texas, Forenede Stater, 76104
- Texas Retina Associates
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Katy, Texas, Forenede Stater, 77494
- Retina Consultants of Texas
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Nashville, Texas, Forenede Stater, 37203
- Tennessee Retina PC
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San Antonio, Texas, Forenede Stater, 78240
- Retina Consultants of Texas San Antonio
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The Woodlands, Texas, Forenede Stater, 77384
- Retina Consultants of Texas
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Willow Park, Texas, Forenede Stater, 76087
- Strategic Clinical Research Group, LLC
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Utah
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Salt Lake City, Utah, Forenede Stater, 84107
- Rocky Mountain Retina Consultants
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Virginia
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Lynchburg, Virginia, Forenede Stater, 24502
- Piedmont Eye Center
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Wisconsin
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Wausau, Wisconsin, Forenede Stater, 54403
- Eye Clinic of Wisconsin
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Bordeaux, Frankrig, 33076
- Groupe Hospitalier Pellegrin - CHU de Bordeaux
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Créteil, Frankrig, 94000
- Centre Hospitalier Intercommunal De Créteil
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Dijon, Frankrig, 21079
- CHU Dijon Bourgogne - Hôpital François Mitterrand
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Marseille, Frankrig
- Centre Monticelli Paradis d'Ophtalmologie
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Nice, Frankrig, 06001
- Centre Hospitalier Universitaire de Nice
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Paris, Frankrig, 75010
- Hôpital Lariboisière - Service d'ophtalmologie
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Strasbourg, Frankrig, 67000
- Centre Ophtalmologique Maison Rouge
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Écully, Frankrig
- Centre Ophtalmologique Pôle Vision Val d'Ouest
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Tilburg, Holland, 5042 AD
- Elisabeth Hospital (ETZ) - location TweeSteden ziekenhuis
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Florence, Italien, 50134
- Azienda Ospedaliera Universitaria Careggi
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Milan, Italien, 20122
- Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
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Milan, Italien, 20132
- IRCCS Ospedale San Raffaele
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Milan, Italien, 20123
- IRCCS MultiMedica
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Milan, Italien, 20157
- ASST Fatebenefratelli Sacco
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Roma, Italien, 00184
- Fondazione G.B. Bietti Per Lo Sudio E La Ricerca In Oftalmologia - Presidio
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Rome, Italien, 00133
- Fondazione PTV Policlinico Tor Vergata
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Rome, Italien, 00168
- Fondazione Policlinico Agostino Gemelli
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Canterbury
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Christchurch, Canterbury, New Zealand, 8013
- Southern Eye Specialists
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Wellington Region
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Te Aro, Wellington Region, New Zealand, 6011
- Capital Eye Specialists
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Bydgoszcz, Polen, 85-631
- Oftalmika Sp.Zo.O.
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Olsztyn, Polen, 10-424
- Centrum Diagnostyki I Mikrochirurgii Oka Lens Sp. Z O.O.
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Rzeszów, Polen, 35-017
- Ośrodek Chirurgii Oka Prof. Zagórskiego Sp. Z o.o.
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Tarnowskie Góry, Polen, 42-600
- Caminomed Sp. Z O.O.
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Warsaw, Polen, 01-258
- Warszawski Szpital Okulistyczny
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Barcelona, Spanien, 08035
- Hospital Universitari Vall d'Hebron
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Barcelona, Spanien, 08017
- Institut Català de Retina
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Córdoba, Spanien, 14012
- Hospital de la Arruzafa - Metavisión Arruzafa
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Madrid, Spanien, 28046
- Clínica Baviera
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Majadahonda, Spanien, 28222
- Hospital Universitario Puerta de Hierro - Majadahonda
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Sant Cugat del Vallès, Spanien, 08195
- Hospital Universitari General de Catalunya - Valles Ophthalmology Research - OMIQ Research
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Santiago de Compostela, Spanien, 15706
- Hospital Clinico Universitario de Santiago
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Seville, Spanien, 41009
- Hospital Universitario Virgen Macarena
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Zaragoza, Spanien, 50009
- Hospital Universitario Miguel Servet
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Burjassot
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Valencia, Burjassot, Spanien, 46100
- Oftalvist IMED Burjassot
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Prague, Tjekkiet, 150 00
- Axon Clinical, s.r.o. Ocni Klinika
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Prague, Tjekkiet, 100 34
- Fakultní nemocnice Královské Vinohrady
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Prague, Tjekkiet, 128 08
- Všeobecná fakultní nemocnice V Praze
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Bonn, Tyskland, 53127
- Universitäts-Klinikum Bonn
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Heidelberg, Tyskland, 69120
- Universitätsklinikum Heidelberg
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Tübingen, Tyskland, 72076
- Universitätsklinikum Tübingen, Department für Augenheilkunde
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Mecklenburg-Vorpommern
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Neubrandenburg, Mecklenburg-Vorpommern, Tyskland, 17036
- Dietrich Bonhoeffer Klinikum Klinik für Augenheilkunde
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North Rhine-Westphalia
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Münster, North Rhine-Westphalia, Tyskland, 48145
- Augenzentrum am St. Franziskus-Hospital
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Budapest, Ungarn, 1085
- Semmelweis Egyetem
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Budapest, Ungarn, 1133
- Budapest Retina Associates
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Budapest, Ungarn, 1106
- Budapesti Bajcsy-Zsilinszky Kórház és Rendelőintézet Szemészet Osztály
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Baranya
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Pécs, Baranya, Ungarn, 7621
- Ganglion Medical Center
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Hajdú-Bihar
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Debrecen, Hajdú-Bihar, Ungarn, 4032
- Debreceni Egyetem Klinikai Kozpont Nagyerdei Campus
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Klagenfurt, Østrig, 9020
- Klinikum Klagenfurt am Wörthersee
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Linz, Østrig, 4020
- Kepler Universitätsklinikum
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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
50 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Diagnosis of dry AMD with GA as determined by the Investigator and confirmed by the independent Central Reading Center.
Exclusion Criteria:
- Geographic atrophy due to other causes than AMD such as Stargardt disease, cone-rod dystrophy, pathologic myopia, or toxic maculopathies (for example, plaquenil maculopathy) in either eye.
NOTE: Other protocol-defined inclusion and exclusion criteria apply.
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: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Vonaprument
Participants will receive vonaprument IVT injections every month during the 24-month treatment period. |
Form: solution for injection; Route of Administration: IVT injection
Andre navne:
|
|
Sham-komparator: Sham Group
Participants will receive Sham IVT injections every month during the 24-month treatment period. |
Form and Route of Administration: to mimic IVT injection (includes placement of the blunt opening of an empty, needleless syringe barrel on the conjunctiva in the inferotemporal quadrant of the eyeball to stimulate the pressure of an injection). |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Proportion of Participants Experiencing a Best Corrected Visual Acuity (BCVA) ≥15-letter Loss from Baseline Through Month 15 as Assessed by the Early Treatment Diabetic Retinopathy Study (ETDRS) Chart at Any Two Consecutive Visits
Tidsramme: Baseline through Month 15
|
Baseline through Month 15
|
|
Proportion of Participants Experiencing a BCVA ≥15-letter Loss from Baseline Through Month 24 as Assessed by the ETDRS Chart at Any Two Consecutive Visits
Tidsramme: Baseline through Month 24
|
Baseline through Month 24
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Time to Confirmed BCVA ≥15-letter Loss
Tidsramme: Baseline to Month 15 and Baseline to Month 24
|
Baseline to Month 15 and Baseline to Month 24
|
|
Proportion of Participants with Low-luminance BCVA (LLVA) ≥15-letter Loss
Tidsramme: Baseline through Month 15 and Baseline through Month 24
|
Baseline through Month 15 and Baseline through Month 24
|
|
Change from Baseline in Area of Total Loss of the Ellipsoid Zone (EZ) Layer
Tidsramme: Baseline, Month 15 and 24
|
Baseline, Month 15 and 24
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Clinical Trials, Annexon, Inc.
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)
30. juli 2024
Primær færdiggørelse (Anslået)
31. juli 2027
Studieafslutning (Anslået)
31. juli 2027
Datoer for studieregistrering
Først indsendt
15. juli 2024
Først indsendt, der opfyldte QC-kriterier
15. juli 2024
Først opslået (Faktiske)
19. juli 2024
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
6. oktober 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
2. oktober 2026
Sidst verificeret
1. oktober 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- ANX007-GA-02
- 2024-515022-88-00 (Ctis)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
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 .