En undersøgelse, der undersøger subkutant administreret Pozelimab i kombination med Cemdisiran eller Cemdisiran alene hos voksne deltagere med geografisk atrofi (SIENNA)
9. oktober 2026 opdateret af: Regeneron Pharmaceuticals
Et multicenter, randomiseret, dobbeltmasket, placebokontrolleret fase 3-studie af effektivitet, sikkerhed og tolerabilitet af subkutant administreret Pozelimab i kombination med Cemdisiran eller Cemdisiran alene hos deltagere med geografisk atrofi sekundært til aldersrelateret makuladegeneration
This study is researching experimental (study) drugs called pozelimab and cemdisiran. The study is focused on participants who have Geographic Atrophy (GA) caused by Age-related Macular Degeneration (AMD). Geographic atrophy is a medical term that refers to later-stage cases of AMD which is an eye condition affecting central vision (what one sees straight ahead).
The purpose of this study is to evaluate the progression rate of Geographic Atrophy in eyes of patients treated with cemdisiran alone or in combination with pozelimab compared to those treated with placebo.
The study is looking at several other research questions, including:
- What side effects may happen from taking the study drug(s)
- How much study drug(s) are in the blood at different times
- Whether the body makes antibodies against the study drug(s) (which could make the study drug(s) less effective or could lead to side effects)
Studieoversigt
Status
Rekruttering
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
975
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Clinical Trials Administrator
- Telefonnummer: 844-734-6643
- E-mail: clinicaltrials@regeneron.com
Studiesteder
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New South Wales
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Albury, New South Wales, Australien, 2640
- Rekruttering
- Eye Clinic Albury Wodonga
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Hurstville, New South Wales, Australien, 2220
- Rekruttering
- Retina and Eye Consultants
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Strathfield, New South Wales, Australien, 2135
- Rekruttering
- Strathfield Retina Clinic
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South Australia
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Adelaide, South Australia, Australien, 5000
- Rekruttering
- Adelaide Eye and Retina Centre-Opthamalogy
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Victoria
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East Melbourne, Victoria, Australien, 3002
- Rekruttering
- Centre for Eye Research Australia (CERA)
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Québec, Canada, G1S 4L8
- Rekruttering
- Centre Hospitalier Universitaire de Quebec Universite Laval
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Ontario
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Ottawa, Ontario, Canada, K2B 7E9
- Rekruttering
- Retina Centre of Ottawa
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Bristol, Det Forenede Kongerige, BS1 2LX
- Rekruttering
- University Hospitals Bristol NHS Foundation Trust
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London, Det Forenede Kongerige, NW1 5QH
- Rekruttering
- Imperial College Healthcare NHS Trust
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London, Det Forenede Kongerige, EC1V 2PD
- Rekruttering
- Moorfields Eye Hospital NHS Foundation Trust, Moorfields Eye Hospital
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Newcastle upon Tyne, Det Forenede Kongerige, NE1 4LP
- Rekruttering
- The Newcastle Upon Tyne Hospitals NHS Foundation Trust
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Merseyside
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Liverpool, Merseyside, Det Forenede Kongerige, L7 8XP
- Rekruttering
- Liverpool University Hospitals NHS Foundation Trust-Royal Liverpool University Hospital, St Paul's Eye Unit-Ophthalmology
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North Yorkshire
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York, North Yorkshire, Det Forenede Kongerige, YP31 8HE
- Rekruttering
- York and Scarborough Teaching Hospitals NHS Foundation Trust
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Arizona
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Chandler, Arizona, Forenede Stater, 85224
- Rekruttering
- Barnet Dulaney Perkins Eye Center-Ophthamalogy
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Phoenix, Arizona, Forenede Stater, 85053
- Rekruttering
- Retinal Research Institute
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Phoenix, Arizona, Forenede Stater, 85020
- Rekruttering
- Associated Retina Consultants
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Phoenix, Arizona, Forenede Stater, 85016
- Rekruttering
- Barnet Dulaney Perkins Eye Center
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Scottsdale, Arizona, Forenede Stater, 85255
- Rekruttering
- Retina Macula Institute of Arizona
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Tucson, Arizona, Forenede Stater, 85712
- Rekruttering
- Retina Associates of Tuscan
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Arkansas
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Springdale, Arkansas, Forenede Stater, 72764
- Rekruttering
- Retina Partners of Northwest Arkansas, PLLC
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California
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Beverly Hills, California, Forenede Stater, 90211
- Rekruttering
- Retina Vitreous Associates Medical Group
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Beverly Hills, California, Forenede Stater, 90212
- Rekruttering
- Retina Specialists of Beverly Hills- Department of Ophthalmology
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Encino, California, Forenede Stater, 91436
- Afsluttet
- The Retina Partners
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Fresno, California, Forenede Stater, 93720
- Rekruttering
- Eye Medical Center of Fresno
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Fullerton, California, Forenede Stater, 92835
- Afsluttet
- Retina Consultants of Orange County
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Huntington Beach, California, Forenede Stater, 92647
- Rekruttering
- Salehi Retina Institute dba Retina Associates of Southern California
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Irvine, California, Forenede Stater, 92617
- Rekruttering
- University of California Irvine
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La Jolla, California, Forenede Stater, 92093
- Rekruttering
- University of California San Diego, Jacobs Retina Center
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Long Beach, California, Forenede Stater, 90807
- Rekruttering
- South Coast Retina Center
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Los Angeles, California, Forenede Stater, 90027
- Rekruttering
- Kaiser Permanente Los Angeles Medical Center
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Los Angeles, California, Forenede Stater, 90017
- Afsluttet
- American Institute of Research
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Los Angeles, California, Forenede Stater, 90095
- Rekruttering
- Jules Stein Eye Institute in David Geffen School of Medicine at UCLA
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Modesto, California, Forenede Stater, 95356
- Rekruttering
- Retinal Consultants Medical Group Inc Modesto
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Mountain View, California, Forenede Stater, 94040
- Rekruttering
- Northern California Retina Vitreous Associates Medical Group, Inc.
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Oxnard, California, Forenede Stater, 93036
- Rekruttering
- California Retina Consultants
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Palm Desert, California, Forenede Stater, 92211
- Trukket tilbage
- Desert Retina Consultants
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Pasadena, California, Forenede Stater, 91107
- Rekruttering
- California Eye Specialists Medical Group Inc.
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Poway, California, Forenede Stater, 92064
- Rekruttering
- Retina Consultants San Diego
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Redlands, California, Forenede Stater, 92373
- Rekruttering
- California Eye Specialists Medical Group, Inc.
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Rowland Heights, California, Forenede Stater, 91748
- Rekruttering
- Optic Eye Care
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Sacramento, California, Forenede Stater, 95817
- Rekruttering
- UC Davis Health Eye Center
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Sacramento, California, Forenede Stater, 95825
- Rekruttering
- Vrmg Inc
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Sacramento, California, Forenede Stater, 95841
- Rekruttering
- Retinal Consultants Medical Group (RCMG) - Greenback Lane Retina Center
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San Francisco, California, Forenede Stater, 94109
- Rekruttering
- West Coast Retina Medical Group, Inc.
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Santa Ana, California, Forenede Stater, 92705
- Rekruttering
- Orange County Retina Medical Group
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Torrance, California, Forenede Stater, 90503
- Rekruttering
- Macula Retina Vitreous Research Institute
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Colorado
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Aurora, Colorado, Forenede Stater, 80045
- Rekruttering
- University of Colorado
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Colorado Springs, Colorado, Forenede Stater, 80909
- Rekruttering
- Retina Consultants of Southern Colorado
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Denver, Colorado, Forenede Stater, 80222
- Rekruttering
- Retina Specialists of Colorado - Denver
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Durango, Colorado, Forenede Stater, 81303
- Rekruttering
- Southwest Retina Research Center
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Lakewood, Colorado, Forenede Stater, 80228
- Rekruttering
- Colorado Retina - Lakewood
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Longmont, Colorado, Forenede Stater, 80503
- Rekruttering
- Eye care Center of Northern Colorado doing business as Advanced Vision Research Institute
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Connecticut
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Manchester, Connecticut, Forenede Stater, 06042
- Rekruttering
- Retina Consultants - Manchester
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Waterford, Connecticut, Forenede Stater, 06385
- Afsluttet
- Retina Group of New England
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Florida
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Bonita Springs, Florida, Forenede Stater, 34134
- Rekruttering
- Advanced Retina Institute-Ophthalmology
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Coral Springs, Florida, Forenede Stater, 33067
- Rekruttering
- Advanced Research
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Fort Lauderdale, Florida, Forenede Stater, 33308
- Rekruttering
- Retina Group of Florida
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Fort Myers, Florida, Forenede Stater, 33912
- Trukket tilbage
- National Ophthalmic Research Institute
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Hudson, Florida, Forenede Stater, 34667
- Rekruttering
- ClearVista Clinical Research, Retina Center Tampa Bay
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Jacksonville, Florida, Forenede Stater, 32216
- Rekruttering
- Florida Retina Institute, Jacksonville Perimeter Park- Ophthalmology
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Lakeland, Florida, Forenede Stater, 33805
- Rekruttering
- Florida Retina Consultants
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Naples, Florida, Forenede Stater, 34103
- Rekruttering
- Bascom Palmer Eye Institute
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Orlando, Florida, Forenede Stater, 32806
- Rekruttering
- Florida Retina Institute - Orlando
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Palm Beach Gardens, Florida, Forenede Stater, 33410
- Rekruttering
- Retina Care Specialists
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Pinellas Park, Florida, Forenede Stater, 33782
- Rekruttering
- Eye Associates of Pinellas
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Sarasota, Florida, Forenede Stater, 34232
- Rekruttering
- Retina Group of Florida, RAS-Sarasota Retina Center-Ophthalmology
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St. Petersburg, Florida, Forenede Stater, 33711
- Rekruttering
- Retina Vitreous Associates of Florida Saint Petersburg
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Tampa, Florida, Forenede Stater, 33612
- Rekruttering
- University of South Florida Ophthalmology
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Winter Haven, Florida, Forenede Stater, 33880
- Rekruttering
- Center for Retina and Macular Disease
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Georgia
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Augusta, Georgia, Forenede Stater, 30909
- Rekruttering
- Southeast Retina Center
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Marietta, Georgia, Forenede Stater, 30060
- Rekruttering
- Georgia Retina - Marietta
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Illinois
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Chicago, Illinois, Forenede Stater, 60612
- Rekruttering
- University of Illinois at Chicago
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Chicago, Illinois, Forenede Stater, 60637
- Rekruttering
- The University of Chicago
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Chicago, Illinois, Forenede Stater, 60616
- Rekruttering
- Retinal Vitreal Consultants
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Lemont, Illinois, Forenede Stater, 60439
- Rekruttering
- University Retina and Macula Associates PC - Lemont
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Oak Park, Illinois, Forenede Stater, 60304
- Rekruttering
- Illinois Retina Associates
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Springfield, Illinois, Forenede Stater, 62703
- Rekruttering
- Springfield Clinic Main Campus East
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Indiana
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Carmel, Indiana, Forenede Stater, 46032
- Rekruttering
- Midwest Eye Institute
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Kansas
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Lenexa, Kansas, Forenede Stater, 66215
- Rekruttering
- Retina Associates, LLC
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Kentucky
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Louisville, Kentucky, Forenede Stater, 40202
- Rekruttering
- University of Louisville
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Louisiana
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Metairie, Louisiana, Forenede Stater, 70001
- Rekruttering
- Retina Associate New Orleans
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Metairie, Louisiana, Forenede Stater, 70001
- Rekruttering
- Ross Davis Retina
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New Orleans, Louisiana, Forenede Stater, 70121
- Rekruttering
- Ochsner Health
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West Monroe, Louisiana, Forenede Stater, 71291
- Rekruttering
- Eye Associates of Northeast Louisiana dba Haik Humble Eye Center
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West Monroe, Louisiana, Forenede Stater, 71291
- Rekruttering
- Eye Assoc. of NE LA dba Haik Humble Eye Ctr
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Maryland
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Baltimore, Maryland, Forenede Stater, 21209
- Rekruttering
- The Retina Care Center
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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
- Mid Atlantic Retina Specialist
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Hagerstown, Maryland, Forenede Stater, 21740
- Rekruttering
- Cumberland Valley Retina Consultants-Ophthalmology
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02114
- Rekruttering
- Opthalmic Consultants of Boston
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Boston, Massachusetts, Forenede Stater, 02114
- Rekruttering
- Massachusetts Eye And Ear Infirmary
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Springfield, Massachusetts, Forenede Stater, 01107
- Rekruttering
- New England Retina Consultants, PC
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Waltham, Massachusetts, Forenede Stater, 02451
- Rekruttering
- Massachusetts Eye Research and Surgery Institution (MERSI)
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Worcester, Massachusetts, Forenede Stater, 01605
- Rekruttering
- Vitreo-Retinal Associates PC
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Michigan
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Grand Blanc, Michigan, Forenede Stater, 48439
- Rekruttering
- Retina Associates of Michigan
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Mississippi
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Madison, Mississippi, Forenede Stater, 39110
- Rekruttering
- Mississippi Retina Associates
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Southaven, Mississippi, Forenede Stater, 38671
- Rekruttering
- Deep Blue Retina Clinical Research PLLC
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Missouri
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St Louis, Missouri, Forenede Stater, 63144
- Rekruttering
- Retina Research Institute, LLC
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New Hampshire
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Nashua, New Hampshire, Forenede Stater, 03063
- Rekruttering
- Nashua Eye Associates
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New Jersey
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Cherry Hill, New Jersey, Forenede Stater, 08034
- Rekruttering
- Mid Atlantic Retina - Cherry Hill
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Teaneck, New Jersey, Forenede Stater, 07666
- Rekruttering
- New Jersey Retina
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Toms River, New Jersey, Forenede Stater, 08755
- Rekruttering
- New Jersey Retina
-
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New Mexico
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Albuquerque, New Mexico, Forenede Stater, 87109
- Rekruttering
- Vision Research Center at Eye Associates of New Mexico
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Albuquerque, New Mexico, Forenede Stater, 87131
- Afsluttet
- University of New Mexico, HSC
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New York
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Brentwood, New York, Forenede Stater, 11717
- Rekruttering
- Sight MD
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Liverpool, New York, Forenede Stater, 13088
- Rekruttering
- Retina Vitreous Surgeons of Central New York, PC
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New York, New York, Forenede Stater, 10028
- Rekruttering
- New York Ear & Eye- East 85th
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New York, New York, Forenede Stater, 10075
- Rekruttering
- Retina Associates of New York, Upper East Side
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New York, New York, Forenede Stater, 10065
- Rekruttering
- Northwell Health- Manhattan, Ear, Eye and Throat Hospital- Ophthalmology
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New York, New York, Forenede Stater, 10021
- Trukket tilbage
- MaculaCare, PLLC
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Poughkeepsie, New York, Forenede Stater, 12603
- Rekruttering
- Seeta Eye center
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North Carolina
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Asheville, North Carolina, Forenede Stater, 28803
- Afsluttet
- Western Carolina Retinal Associates
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Cary, North Carolina, Forenede Stater, 27511
- Rekruttering
- NC Retina Associates
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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
- North Carolina Retina Associates
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Winston-Salem, North Carolina, Forenede Stater, 27103
- Rekruttering
- Piedmont Retina Specialist
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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, 44106
- Rekruttering
- University Hospitals Cleveland Medical Center
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Columbus, Ohio, Forenede Stater, 43212
- Rekruttering
- The Ohio State University
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Dublin, Ohio, Forenede Stater, 43016
- Rekruttering
- Midwest Retina, Inc
-
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Oklahoma
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Edmond, Oklahoma, Forenede Stater, 73013
- Rekruttering
- Retina Vitreous Center - Edmond
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Tulsa, Oklahoma, Forenede Stater, 74114
- Rekruttering
- Tulsa Retina Consultants
-
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Oregon
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Eugene, Oregon, Forenede Stater, 97401
- Rekruttering
- Verum Research LLC
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Portland, Oregon, Forenede Stater, 97225
- Rekruttering
- EyeHealth Northwest
-
Portland, Oregon, Forenede Stater, 97221
- Rekruttering
- Retina Northwest, The Highlands Building
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Portland, Oregon, Forenede Stater, 97239
- Rekruttering
- OHSU-Casey Eye Institute, Marquam Hill-Ophthalmology
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Springfield, Oregon, Forenede Stater, 97477
- Rekruttering
- Cascade Medical Research Institute LLC
-
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Pennsylvania
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Bethlehem, Pennsylvania, Forenede Stater, 18017
- Rekruttering
- Mid Atlantic Retina
-
Erie, Pennsylvania, Forenede Stater, 16507
- Rekruttering
- Erie Retinal Surgery & Erie Retina Research
-
Philadelphia, Pennsylvania, Forenede Stater, 19107
- Rekruttering
- Mid Atlantic Retina, Wills Eye Hospital
-
Philadelphia, Pennsylvania, Forenede Stater, 19141
- Rekruttering
- Vision Research Solutions - the Eye Institute
-
Sewickley, Pennsylvania, Forenede Stater, 15143
- Rekruttering
- Sewickley Eye Group
-
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South Carolina
-
Greenville, South Carolina, Forenede Stater, 29605
- Rekruttering
- Retina Consultants of Carolina
-
Ladson, South Carolina, Forenede Stater, 29456
- Rekruttering
- Charleston Neuroscience Institute LLC
-
Mt. Pleasant, South Carolina, Forenede Stater, 29464
- Rekruttering
- Charleston Neuroscience Institute, LLC
-
West Columbia, South Carolina, Forenede Stater, 29169
- Rekruttering
- Palmetto Retina Center
-
-
South Dakota
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Rapid City, South Dakota, Forenede Stater, 57701
- Rekruttering
- Black Hills Regional Eye Institute
-
Sioux Falls, South Dakota, Forenede Stater, 57108
- Rekruttering
- Ophthalmology, LTD - Sioux Falls
-
-
Tennessee
-
Nashville, Tennessee, Forenede Stater, 37203
- Rekruttering
- Tennessee Retina, PC
-
Nashville, Tennessee, Forenede Stater, 37232
- Rekruttering
- Vanderbilt Eye Institute
-
-
Texas
-
Abilene, Texas, Forenede Stater, 79606
- Rekruttering
- Retina Research Institute of Texas
-
Austin, Texas, Forenede Stater, 78705
- Rekruttering
- Austin Research Center for Retina
-
Austin, Texas, Forenede Stater, 78705
- Rekruttering
- Austin Retina Associates
-
Austin, Texas, Forenede Stater, 78750
- Trukket tilbage
- Austin Clinical Research LLC
-
Bellaire, Texas, Forenede Stater, 77401
- Rekruttering
- Retina Consultants Texas
-
Burleson, Texas, Forenede Stater, 76028
- Rekruttering
- Star Retina PLLC
-
Dallas, Texas, Forenede Stater, 75390
- Rekruttering
- University of Texas Southwestern Medical Center
-
Dallas, Texas, Forenede Stater, 75231
- Rekruttering
- Texas Retina Associates
-
Dallas, Texas, Forenede Stater, 75231
- Rekruttering
- Retina Foundation of the Southwest
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Katy, Texas, Forenede Stater, 77494
- Rekruttering
- Retina Consultants of Texas
-
McAllen, Texas, Forenede Stater, 78503
- Rekruttering
- Valley Retina Institute, P.A.
-
Plano, Texas, Forenede Stater, 75024
- Afsluttet
- Red River Research Partners (Formerly AXIS Clinical)
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Round Rock, Texas, Forenede Stater, 78681
- Rekruttering
- Austin Retina Associates
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San Antonio, Texas, Forenede Stater, 78240
- Rekruttering
- Medical Center Ophthalmology Associates
-
San Antonio, Texas, Forenede Stater, 78240
- Rekruttering
- Retina Consultants of Texas
-
San Antonio, Texas, Forenede Stater, 78240
- Rekruttering
- Retina Associates of South Texas
-
San Antonio, Texas, Forenede Stater, 78251
- Rekruttering
- Retina Consultants of Texas Brown Retina Institute
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Southlake, Texas, Forenede Stater, 76092
- Rekruttering
- Retina Center of Texas
-
The Woodlands, Texas, Forenede Stater, 77384
- Rekruttering
- Retina Consultants Texas
-
Tyler, Texas, Forenede Stater, 75703
- Rekruttering
- Tyler Retina Research Institute- Ophthalmology
-
-
Utah
-
Salt Lake City, Utah, Forenede Stater, 84107
- Rekruttering
- Rocky Mountain Retina Consultants
-
Salt Lake City, Utah, Forenede Stater, 84107
- Rekruttering
- Retina Associates Of Utah Retina Specialist
-
West Jordan, Utah, Forenede Stater, 84088
- Rekruttering
- Salt Lake Retina- Ophthalmology
-
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Vermont
-
Burlington, Vermont, Forenede Stater, 05401
- Rekruttering
- University of Vermont
-
-
Virginia
-
Bristol, Virginia, Forenede Stater, 24201
- Rekruttering
- Southeastern Retina Associates
-
Fairfax, Virginia, Forenede Stater, 22031
- Rekruttering
- Retina Group of Washington
-
Lynchburg, Virginia, Forenede Stater, 24502
- Rekruttering
- Piedmont Eye Center
-
Richmond, Virginia, Forenede Stater, 23226
- Rekruttering
- Virginia Eye Institute
-
Richmond, Virginia, Forenede Stater, 23235
- Afsluttet
- Retina Institute of Virginia
-
-
Washington
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Spokane, Washington, Forenede Stater, 99204
- Rekruttering
- Spokane Eye Clinical Research
-
-
West Virginia
-
Morgantown, West Virginia, Forenede Stater, 26506
- Trukket tilbage
- West Virginia University Eye Institute
-
-
-
-
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Créteil, Frankrig, 94010
- Rekruttering
- Centre Hospitalier Intercommunal de Creteil
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Dijon, Frankrig, 21000
- Rekruttering
- Centre Hospitalier Universitaire Francois Mitterrand
-
Lille, Frankrig, 59800
- Rekruttering
- Intercard
-
Lyon, Frankrig, 69317
- Rekruttering
- Pole Vision Val d'Ouest
-
Lyon, Frankrig, 69317
- Rekruttering
- Hopital De La Croix-Rousse
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Marseille, Frankrig, 13008
- Rekruttering
- Centre Monticelli Paradis
-
Nantes, Frankrig, 44000
- Rekruttering
- Centre Hospitalier Universitaire de Nantes
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Paris, Frankrig, 75010
- Rekruttering
- Hopital Lariboisiere
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Rouen, Frankrig, 76100
- Rekruttering
- Clinique Mathilde
-
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Alpes Maritimes
-
Nice, Alpes Maritimes, Frankrig, 6002
- Rekruttering
- Centre Hospitalier Universitaire de Nice
-
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Bouches Du Rhone
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Marseille, Bouches Du Rhone, Frankrig, 13008
- Rekruttering
- Hopital Saint Joseph
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New Aquitaine
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Poitiers, New Aquitaine, Frankrig, 86000
- Rekruttering
- Centre Hospitalier Universitaire De Poitiers
-
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Occitanie
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Toulouse, Occitanie, Frankrig, 31059
- Rekruttering
- Toulouse University Hospital
-
-
-
-
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Ancona, Italien, 60126
- Rekruttering
- Azienda Ospedaliero Universitaria delle Marche
-
Milan, Italien, 20157
- Rekruttering
- Universita degli Studi di Milano
-
Rome, Italien, 00184
- Rekruttering
- Fondazione G.B.Bietti Per Lo Studio E La Ricerca In Oftalmologia
-
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Lazio
-
Rome, Lazio, Italien, 00168
- Rekruttering
- Fondazione Policlinico Gemelli
-
Rome, Lazio, Italien, 00133
- Rekruttering
- University Hospital PTV
-
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Lombardy
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Milan, Lombardy, Italien, 20123
- Rekruttering
- IRCCS MultiMedica
-
Milan, Lombardy, Italien, 20122
- Rekruttering
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
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Milano
-
Milan, Milano, Italien, 20132
- Rekruttering
- Ospedale San Raffaele (HSR) - Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS)
-
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Tuscany
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Florence, Tuscany, Italien, 50134
- Rekruttering
- Azienda Ospedaliero Universitaria Careggi
-
-
-
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Kuyavian-Pomeranian Voivodeship
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Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Polen, 85-631
- Rekruttering
- Oftalmika Sp. z o.o.
-
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Silesian Voivodeship
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Tarnowskie Góry, Silesian Voivodeship, Polen, 42-600
- Rekruttering
- Caminomed
-
-
Warmian-Masurian Voivodeship
-
Olsztyn, Warmian-Masurian Voivodeship, Polen, 10-424
- Rekruttering
- Centrum Diagnostyki I Mikrochirurgii Oka Lens Sp zoo
-
-
-
-
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Barcelona, Spanien, 08021
- Rekruttering
- Centro de Oftalmologia Barraquer
-
Barcelona, Spanien, 08035
- Rekruttering
- Instituto de Microcirugia Ocular
-
Barcelona, Spanien, 8022
- Rekruttering
- Institut Catala De Retina S.L.
-
Seville, Spanien, 41009
- Rekruttering
- Hospital Universitario Virgen Macarena
-
Valencia, Spanien, 46004
- Rekruttering
- Fundacion Aiken De La Comunitat Valenciana
-
Zaragoza, Spanien, 50009
- Rekruttering
- Miguel Servet University Hospital
-
Zaragoza, Spanien, 50009
- Rekruttering
- Hospital Clinico Universitario Lozano Blesa. IIS Aragon
-
-
Andalusia
-
Córdoba, Andalusia, Spanien, 14012
- Rekruttering
- Hospital Arruzafa
-
-
Barcelona
-
L'Hospitalet de Llobregat, Barcelona, Spanien, 8907
- Rekruttering
- Bellvitge University Hospital
-
Terrassa, Barcelona, Spanien, 08227
- Rekruttering
- Hospital de Terrassa (Consorci Sanitari de Terrassa)
-
-
Valencia
-
Burjassot, Valencia, Spanien, 46100
- Rekruttering
- Oftalvist Clinic. IMED Hospital
-
-
-
-
-
Hamburg, Tyskland, 20246
- Rekruttering
- University Hospital Hamburg Eppendorf
-
Mainz, Tyskland, 55131
- Rekruttering
- University Medical Center of the Johannes Gutenberg-University Mainz
-
Münster, Tyskland, 48145
- Rekruttering
- St. Franziskus-Hospital
-
Würzburg, Tyskland, 97080
- Rekruttering
- Universitaetsklinikum Wuerzburg AöR
-
-
Baden-Wurttemberg
-
Ulm, Baden-Wurttemberg, Tyskland, 89081
- Rekruttering
- University of Ulm
-
-
Brandenburg
-
Berlin, Brandenburg, Tyskland, 12203
- Rekruttering
- Charite - Universitaetsmedizin Berlin
-
-
Hesse
-
Frankfurt am Main, Hesse, Tyskland, 60549
- Rekruttering
- Augenzentrum Frankfurt
-
Marburg, Hesse, Tyskland, 35043
- Rekruttering
- Universitaetsklinikum Marburg, Klinik fuer Augenheilkunde
-
-
Lower Saxony
-
Göttingen, Lower Saxony, Tyskland, 37075
- Rekruttering
- University Medicine Goetting
-
-
Mecklenburg-Vorpommern
-
Neubrandenburg, Mecklenburg-Vorpommern, Tyskland, 17036
- Rekruttering
- Dietrich Bonhoeffer Klinikum
-
-
North Rhine-Westphalia
-
Bonn, North Rhine-Westphalia, Tyskland, 53127
- Rekruttering
- Universitatsklinikum Bonn
-
Düsseldorf, North Rhine-Westphalia, Tyskland, 40225
- Rekruttering
- Klinik fur Augenheilkunde Universitatsklinikum Dusseldorf
-
Münster, North Rhine-Westphalia, Tyskland, 48149
- Rekruttering
- Universitaetsklinikum Muenster
-
-
Rhineland-Palatinate
-
Ludwigshafen am Rhein, Rhineland-Palatinate, Tyskland, 67063
- Rekruttering
- Klinikum Ludwigshafen Augenklinik
-
-
Saarland
-
Homburg, Saarland, Tyskland, 66421
- Rekruttering
- Saarland University Medical Center
-
Sulzbach, Saarland, Tyskland, 66280
- Rekruttering
- Knappschaftsklinikum Saar GmbH- Eye Clnic Sulzbach
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-
-
-
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Budapest, Ungarn, 1085
- Rekruttering
- Semmelweis University
-
Budapest, Ungarn, 1133
- Rekruttering
- Budapest Retina Associates
-
-
Baranya
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Pécs, Baranya, Ungarn, 7621
- Rekruttering
- Ganglion Medical Center
-
-
Csongrad-Csanad
-
Szeged, Csongrad-Csanad, Ungarn, 6720
- Rekruttering
- University Of Szeged
-
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Hajdú-Bihar
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Debrecen, Hajdú-Bihar, Ungarn, 4032
- Rekruttering
- University Of Debrecen, Hungary
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-
-
-
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Vienna, Østrig, 1090
- Rekruttering
- Medical University of Vienna
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Vienna, Østrig, 1140
- Rekruttering
- VIROS - Vienna Institute for Research in Ocular Surgery
-
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Styria
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Graz, Styria, Østrig, 8036
- Rekruttering
- Medical University Graz
-
-
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 til 85 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Key Inclusion Criteria:
- Study eye with diagnosis of GA of the macula secondary to AMD as described in the protocol
- Total GA area in the study eye measuring between ≥2.5 mm^2 and ≤17.5 mm^2 as described in the protocol
- BCVA of 55 letters or better using ETDRS charts (20/80 Snellen equivalent) in the study eye as described in the protocol
- Sufficiently clear ocular media, adequate pupillary dilation and fixation to permit quality fundus imaging in the study eye as described in the protocol
- Willing and able to comply with clinic visits and study-related procedures, including completion of the full series of meningococcal vaccinations and pneumococcal vaccination required per protocol
Key Exclusion Criteria:
-
GA in either eye due to causes other than AMD, such as Stargardt disease, cone rod dystrophy or toxic maculopathies like hydroxychloroquine maculopathy
-
History or current evidence of Macular Neovascularization (MNV) and/or exudation or Peripapillary Choroidal Neovascularization (PPCNV) in either eye as described in the protocol
-
Prior or current Intravitreal (IVT) treatment of any kind for any indication in study eye or fellow eye, except approved or investigational IVT complement inhibitor therapy or anti-VEGF therapy, as long as last dose was ≥6 months prior to randomization
-
Prior intraocular surgery except cataract extraction or minimally invasive glaucoma surgery in study eye as long as date of these procedures was ≥3 months prior to randomization
-
Comorbid progressive ocular condition (eg, diabetic retinopathy, macular edema, uncontrolled glaucoma, full thickness macular hole) in study eye that could affect central vision and confound study
-
Any ophthalmologic condition that reduces the clarity of the media and that, in the opinion of the investigator interferes with ophthalmologic examination of the study eye (e.g., advanced cataract or corneal abnormalities) as described in the protocol
Systemic Exclusion criteria
-
History or current use of systemic complement inhibitor therapy within 6 months prior to randomization as described in the protocol
-
History of solid organ or bone marrow transplantation
-
Use of chronic (>14 days) systemic corticosteroids (oral or parenteral, ≥20 mg oral prednisone or equivalent) within the previous 30 days prior to the first screening visit as described in the protocol
-
Current or prior use of systemic immunosuppressive therapy other than corticosteroids within 12 months prior to randomization or the likelihood of treatment with any such agent during the study inclusive of the screening period as described in the protocol
-
Not meeting meningococcal or pneumococcal vaccination requirements as described in the protocol
-
Carrier of Neisseria meningitidis based on culture collected during screening
-
Has a hemoglobin A1C ≥ 8.0% during screening as described in the protocol
NOTE: Other protocol-defined Inclusion/ 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: Pozelimab + Cemdisiran treatment group
Randomized 1:1:1 |
Subcutaneous (SC) injection
Andre navne:
SC injection
Andre navne:
|
|
Eksperimentel: Cemdisiran monotherapy treatment group
Randomized 1:1:1 |
SC injection
Andre navne:
|
|
Placebo komparator: Placebo treatment group
Randomized 1:1:1 |
SC injection |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Væksthastighed (hældning) af det samlede Ga -læsionsområde (MM^2 /år) fra baseline, målt ved fundus autofluorescens (FAF)
Tidsramme: Til uge 52
|
Til uge 52
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Tab af bedst korrigerede synsstyrke (BCVA) ≥15 breve [Tidlig behandling Diabetisk retinopati -undersøgelse (ETDRS)] fra baseline
Tidsramme: I uge 52 og uge 104
|
I uge 52 og uge 104
|
|
Ændring fra baseline i kvantitativ synsstyrke (LC-QVA) med lav kontrast (LC-QVA)
Tidsramme: I uge 52 og uge 104
|
I uge 52 og uge 104
|
|
Ændring fra baseline i lav-luminans lavkontrast kvantitativ synsstyrke (LL-LC-QVA)
Tidsramme: I uge 52 og uge 104
|
I uge 52 og uge 104
|
|
Skift fra baseline i kvantitativ kontrastfølsomhedsfunktion (QCSF)
Tidsramme: I uge 52 og uge 104
|
I uge 52 og uge 104
|
|
Væksthastighed (hældning) af det samlede Ga -læsionsområde (mm^2 /år) fra baseline målt ved FAF
Tidsramme: Til uge 104
|
Til uge 104
|
|
Koncentrationer af total pozelimab i serum
Tidsramme: Gennem uge 52 og gennem uge 104
|
Gennem uge 52 og gennem uge 104
|
|
Koncentrationer af total cemdisiran i plasma
Tidsramme: Gennem uge 52 og gennem uge 104
|
Gennem uge 52 og gennem uge 104
|
|
Ændring fra baseline i koncentration af den samlede komplementkomponent 5 (C5)
Tidsramme: Gennem uge 52 og gennem uge 104
|
Gennem uge 52 og gennem uge 104
|
|
Forekomst af antidrug antistof (ADA) til pozelimab
Tidsramme: Gennem uge 52 og gennem uge 104
|
Gennem uge 52 og gennem uge 104
|
|
Størrelsen af ADA til pozelimab
Tidsramme: Gennem uge 52 og gennem uge 104
|
Gennem uge 52 og gennem uge 104
|
|
Forekomst af ADA til Cemdisiran
Tidsramme: Gennem uge 52 og gennem uge 104
|
Gennem uge 52 og gennem uge 104
|
|
Størrelsen af ADA til Cemdisiran
Tidsramme: Gennem uge 52 og gennem uge 104
|
Gennem uge 52 og gennem uge 104
|
|
Forekomst af neutraliserende antistof (NAB) til pozelimab
Tidsramme: Gennem uge 52 og gennem uge 104
|
Gennem uge 52 og gennem uge 104
|
|
Forekomst af behandling af bivirkninger (TEAS)
Tidsramme: Gennem uge 52, 104, 140 og uge 296
|
Gennem uge 52, 104, 140 og uge 296
|
|
Alvorlighed af tees
Tidsramme: Gennem uge 52, 104, 140 og uge 296
|
Gennem uge 52, 104, 140 og uge 296
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Clinical Trial Management, Regeneron Pharmaceuticals
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
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. oktober 2024
Primær færdiggørelse (Anslået)
31. juli 2028
Studieafslutning (Anslået)
9. april 2033
Datoer for studieregistrering
Først indsendt
2. august 2024
Først indsendt, der opfyldte QC-kriterier
2. august 2024
Først opslået (Faktiske)
7. august 2024
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
13. oktober 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
9. oktober 2026
Sidst verificeret
1. oktober 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- R3918-AMD-2326
- 2023 (U.S. NIH-bevilling/kontrakt)
- 2023-509547-27-00 (Ctis)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
IPD-delingstidsramme
When Regeneron has:
- received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development
- made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry)
- the legal authority to share the data, and
- ensured the ability to protect participant privacy.
IPD-delingsadgangskriterier
Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
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 .