En studie som undersøker subkutant administrert Pozelimab i kombinasjon med Cemdisiran eller Cemdisiran alene hos voksne deltakere med geografisk atrofi (SIENNA)
3. november 2026 oppdatert av: Regeneron Pharmaceuticals
En multisenter, randomisert, dobbeltmasket, placebokontrollert fase 3-studie av effektivitet, sikkerhet og tolerabilitet av subkutant administrert Pozelimab i kombinasjon med Cemdisiran eller Cemdisiran alene hos deltakere med geografisk atrofi sekundært til aldersrelatert makuladegenerasjon
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)
Studieoversikt
Status
Rekruttering
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
975
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Clinical Trials Administrator
- Telefonnummer: 844-734-6643
- E-post: clinicaltrials@regeneron.com
Studiesteder
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New South Wales
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Albury, New South Wales, Australia, 2640
- Rekruttering
- Eye Clinic Albury Wodonga
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Hurstville, New South Wales, Australia, 2220
- Rekruttering
- Retina and Eye Consultants
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Strathfield, New South Wales, Australia, 2135
- Rekruttering
- Strathfield Retina Clinic
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South Australia
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Adelaide, South Australia, Australia, 5000
- Rekruttering
- Adelaide Eye and Retina Centre-Opthamalogy
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Victoria
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East Melbourne, Victoria, Australia, 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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Arizona
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Chandler, Arizona, Forente stater, 85224
- Rekruttering
- Barnet Dulaney Perkins Eye Center-Ophthamalogy
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Phoenix, Arizona, Forente stater, 85053
- Rekruttering
- Retinal Research Institute
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Phoenix, Arizona, Forente stater, 85020
- Rekruttering
- Associated Retina Consultants
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Phoenix, Arizona, Forente stater, 85016
- Rekruttering
- Barnet Dulaney Perkins Eye Center
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Scottsdale, Arizona, Forente stater, 85255
- Rekruttering
- Retina Macula Institute of Arizona
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Tucson, Arizona, Forente stater, 85712
- Rekruttering
- Retina Associates of Tuscan
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Arkansas
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Springdale, Arkansas, Forente stater, 72764
- Rekruttering
- Retina Partners of Northwest Arkansas, PLLC
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California
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Beverly Hills, California, Forente stater, 90211
- Rekruttering
- Retina Vitreous Associates Medical Group
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Beverly Hills, California, Forente stater, 90212
- Rekruttering
- Retina Specialists of Beverly Hills- Department of Ophthalmology
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Encino, California, Forente stater, 91436
- Fullført
- The Retina Partners
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Fresno, California, Forente stater, 93720
- Rekruttering
- Eye Medical Center of Fresno
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Fullerton, California, Forente stater, 92835
- Fullført
- Retina Consultants of Orange County
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Huntington Beach, California, Forente stater, 92647
- Rekruttering
- Salehi Retina Institute dba Retina Associates of Southern California
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Irvine, California, Forente stater, 92617
- Rekruttering
- University of California Irvine
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La Jolla, California, Forente stater, 92093
- Rekruttering
- University of California San Diego, Jacobs Retina Center
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Long Beach, California, Forente stater, 90807
- Rekruttering
- South Coast Retina Center
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Los Angeles, California, Forente stater, 90027
- Rekruttering
- Kaiser Permanente Los Angeles Medical Center
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Los Angeles, California, Forente stater, 90017
- Fullført
- American Institute of Research
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Los Angeles, California, Forente stater, 90095
- Rekruttering
- Jules Stein Eye Institute in David Geffen School of Medicine at UCLA
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Modesto, California, Forente stater, 95356
- Rekruttering
- Retinal Consultants Medical Group Inc Modesto
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Mountain View, California, Forente stater, 94040
- Rekruttering
- Northern California Retina Vitreous Associates Medical Group, Inc.
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Oxnard, California, Forente stater, 93036
- Rekruttering
- California Retina Consultants
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Palm Desert, California, Forente stater, 92211
- Tilbaketrukket
- Desert Retina Consultants
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Pasadena, California, Forente stater, 91107
- Rekruttering
- California Eye Specialists Medical Group Inc.
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Poway, California, Forente stater, 92064
- Rekruttering
- Retina Consultants San Diego
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Redlands, California, Forente stater, 92373
- Rekruttering
- California Eye Specialists Medical Group, Inc.
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Riverside, California, Forente stater, 92505
- Rekruttering
- Kaiser Permanente Riverside Medical Center
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Rowland Heights, California, Forente stater, 91748
- Rekruttering
- Optic Eye Care
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Sacramento, California, Forente stater, 95817
- Rekruttering
- UC Davis Health Eye Center
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Sacramento, California, Forente stater, 95825
- Rekruttering
- Vrmg Inc
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Sacramento, California, Forente stater, 95841
- Rekruttering
- Retinal Consultants Medical Group (RCMG) - Greenback Lane Retina Center
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San Francisco, California, Forente stater, 94109
- Rekruttering
- West Coast Retina Medical Group, Inc.
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Santa Ana, California, Forente stater, 92705
- Rekruttering
- Orange County Retina Medical Group
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Torrance, California, Forente stater, 90503
- Rekruttering
- Macula Retina Vitreous Research Institute
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Colorado
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Aurora, Colorado, Forente stater, 80045
- Rekruttering
- University of Colorado
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Colorado Springs, Colorado, Forente stater, 80909
- Rekruttering
- Retina Consultants of Southern Colorado
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Denver, Colorado, Forente stater, 80222
- Rekruttering
- Retina Specialists of Colorado - Denver
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Durango, Colorado, Forente stater, 81303
- Rekruttering
- Southwest Retina Research Center
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Lakewood, Colorado, Forente stater, 80228
- Rekruttering
- Colorado Retina - Lakewood
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Longmont, Colorado, Forente 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, Forente stater, 06042
- Rekruttering
- Retina Consultants - Manchester
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Waterford, Connecticut, Forente stater, 06385
- Avsluttet
- Retina Group of New England
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Florida
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Bonita Springs, Florida, Forente stater, 34134
- Rekruttering
- Advanced Retina Institute-Ophthalmology
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Coral Springs, Florida, Forente stater, 33067
- Rekruttering
- Advanced Research
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Fort Lauderdale, Florida, Forente stater, 33308
- Rekruttering
- Retina Group of Florida
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Fort Myers, Florida, Forente stater, 33912
- Tilbaketrukket
- National Ophthalmic Research Institute
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Hudson, Florida, Forente stater, 34667
- Rekruttering
- ClearVista Clinical Research, Retina Center Tampa Bay
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Jacksonville, Florida, Forente stater, 32216
- Rekruttering
- Florida Retina Institute, Jacksonville Perimeter Park- Ophthalmology
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Lakeland, Florida, Forente stater, 33805
- Rekruttering
- Florida Retina Consultants
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Naples, Florida, Forente stater, 34103
- Rekruttering
- Bascom Palmer Eye Institute
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Orlando, Florida, Forente stater, 32806
- Rekruttering
- Florida Retina Institute - Orlando
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Palm Beach Gardens, Florida, Forente stater, 33410
- Rekruttering
- Retina Care Specialists
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Pinellas Park, Florida, Forente stater, 33782
- Rekruttering
- Eye Associates of Pinellas
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Sarasota, Florida, Forente stater, 34232
- Rekruttering
- Retina Group of Florida, RAS-Sarasota Retina Center-Ophthalmology
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St. Petersburg, Florida, Forente stater, 33711
- Rekruttering
- Retina Vitreous Associates of Florida Saint Petersburg
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Tampa, Florida, Forente stater, 33612
- Rekruttering
- University of South Florida Ophthalmology
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Winter Haven, Florida, Forente stater, 33880
- Rekruttering
- Center for Retina and Macular Disease
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Georgia
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Augusta, Georgia, Forente stater, 30909
- Rekruttering
- Southeast Retina Center
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Marietta, Georgia, Forente stater, 30060
- Rekruttering
- Georgia Retina - Marietta
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Illinois
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Chicago, Illinois, Forente stater, 60612
- Rekruttering
- University of Illinois at Chicago
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Chicago, Illinois, Forente stater, 60637
- Rekruttering
- The University of Chicago
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Chicago, Illinois, Forente stater, 60616
- Rekruttering
- Retinal Vitreal Consultants
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Lemont, Illinois, Forente stater, 60439
- Rekruttering
- University Retina and Macula Associates PC - Lemont
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Oak Park, Illinois, Forente stater, 60304
- Rekruttering
- Illinois Retina Associates
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Springfield, Illinois, Forente stater, 62703
- Rekruttering
- Springfield Clinic Main Campus East
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Indiana
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Carmel, Indiana, Forente stater, 46032
- Rekruttering
- Midwest Eye Institute
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Kansas
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Lenexa, Kansas, Forente stater, 66215
- Rekruttering
- Retina Associates, LLC
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Kentucky
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Louisville, Kentucky, Forente stater, 40202
- Rekruttering
- University of Louisville
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Louisiana
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Metairie, Louisiana, Forente stater, 70001
- Rekruttering
- Retina Associate New Orleans
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Metairie, Louisiana, Forente stater, 70001
- Rekruttering
- Ross Davis Retina
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New Orleans, Louisiana, Forente stater, 70121
- Rekruttering
- Ochsner Health
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West Monroe, Louisiana, Forente stater, 71291
- Rekruttering
- Eye Associates of Northeast Louisiana dba Haik Humble Eye Center
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West Monroe, Louisiana, Forente stater, 71291
- Rekruttering
- Eye Assoc. of NE LA dba Haik Humble Eye Ctr
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Maryland
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Baltimore, Maryland, Forente stater, 21209
- Rekruttering
- The Retina Care Center
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Chevy Chase, Maryland, Forente stater, 20815
- Rekruttering
- The Retina Group of Washington
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Hagerstown, Maryland, Forente stater, 21740
- Rekruttering
- Mid Atlantic Retina Specialist
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Hagerstown, Maryland, Forente stater, 21740
- Rekruttering
- Cumberland Valley Retina Consultants-Ophthalmology
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Massachusetts
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Boston, Massachusetts, Forente stater, 02114
- Rekruttering
- Opthalmic Consultants of Boston
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Boston, Massachusetts, Forente stater, 02114
- Rekruttering
- Massachusetts Eye And Ear Infirmary
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Springfield, Massachusetts, Forente stater, 01107
- Rekruttering
- New England Retina Consultants, PC
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Waltham, Massachusetts, Forente stater, 02451
- Rekruttering
- Massachusetts Eye Research and Surgery Institution (MERSI)
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Worcester, Massachusetts, Forente stater, 01605
- Rekruttering
- Vitreo-Retinal Associates PC
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Michigan
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Grand Blanc, Michigan, Forente stater, 48439
- Rekruttering
- Retina Associates of Michigan
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Mississippi
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Madison, Mississippi, Forente stater, 39110
- Rekruttering
- Mississippi Retina Associates
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Southaven, Mississippi, Forente stater, 38671
- Rekruttering
- Deep Blue Retina Clinical Research PLLC
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Missouri
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St Louis, Missouri, Forente stater, 63144
- Rekruttering
- Retina Research Institute, LLC
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New Hampshire
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Nashua, New Hampshire, Forente stater, 03063
- Rekruttering
- Nashua Eye Associates
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New Jersey
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Cherry Hill, New Jersey, Forente stater, 08034
- Rekruttering
- Mid Atlantic Retina - Cherry Hill
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Teaneck, New Jersey, Forente stater, 07666
- Rekruttering
- New Jersey Retina
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Toms River, New Jersey, Forente stater, 08755
- Rekruttering
- New Jersey Retina
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New Mexico
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Albuquerque, New Mexico, Forente stater, 87109
- Rekruttering
- Vision Research Center at Eye Associates of New Mexico
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Albuquerque, New Mexico, Forente stater, 87131
- Fullført
- University of New Mexico, HSC
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New York
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Brentwood, New York, Forente stater, 11717
- Rekruttering
- Sight MD
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Liverpool, New York, Forente stater, 13088
- Rekruttering
- Retina Vitreous Surgeons of Central New York, PC
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New York, New York, Forente stater, 10028
- Rekruttering
- New York Ear & Eye- East 85th
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New York, New York, Forente stater, 10075
- Rekruttering
- Retina Associates of New York, Upper East Side
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New York, New York, Forente stater, 10065
- Rekruttering
- Northwell Health- Manhattan, Ear, Eye and Throat Hospital- Ophthalmology
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New York, New York, Forente stater, 10021
- Tilbaketrukket
- MaculaCare, PLLC
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Poughkeepsie, New York, Forente stater, 12603
- Rekruttering
- Seeta Eye center
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North Carolina
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Asheville, North Carolina, Forente stater, 28803
- Fullført
- Western Carolina Retinal Associates
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Cary, North Carolina, Forente stater, 27511
- Rekruttering
- NC Retina Associates
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Hickory, North Carolina, Forente stater, 28602
- Rekruttering
- Graystone Eye
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Wake Forest, North Carolina, Forente stater, 27587
- Rekruttering
- North Carolina Retina Associates
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Winston-Salem, North Carolina, Forente stater, 27103
- Rekruttering
- Piedmont Retina Specialist
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Ohio
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Cincinnati, Ohio, Forente stater, 45242
- Rekruttering
- Cincinnati Eye Institute
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Cleveland, Ohio, Forente stater, 44106
- Rekruttering
- University Hospitals Cleveland Medical Center
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Cleveland, Ohio, Forente stater, 44195
- Rekruttering
- Cole Eye Institute - Cleveland Clinic
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Columbus, Ohio, Forente stater, 43212
- Rekruttering
- The Ohio State University
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Dublin, Ohio, Forente stater, 43016
- Rekruttering
- Midwest Retina, Inc
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Oklahoma
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Edmond, Oklahoma, Forente stater, 73013
- Rekruttering
- Retina Vitreous Center - Edmond
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Tulsa, Oklahoma, Forente stater, 74114
- Rekruttering
- Tulsa Retina Consultants
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Oregon
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Eugene, Oregon, Forente stater, 97401
- Rekruttering
- Verum Research LLC
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Portland, Oregon, Forente stater, 97225
- Rekruttering
- EyeHealth Northwest
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Portland, Oregon, Forente stater, 97221
- Rekruttering
- Retina Northwest, The Highlands Building
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Portland, Oregon, Forente stater, 97239
- Rekruttering
- OHSU-Casey Eye Institute, Marquam Hill-Ophthalmology
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Springfield, Oregon, Forente stater, 97477
- Rekruttering
- Cascade Medical Research Institute LLC
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Pennsylvania
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Bethlehem, Pennsylvania, Forente stater, 18017
- Rekruttering
- Mid Atlantic Retina
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Erie, Pennsylvania, Forente stater, 16507
- Rekruttering
- Erie Retinal Surgery & Erie Retina Research
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Philadelphia, Pennsylvania, Forente stater, 19107
- Rekruttering
- Mid Atlantic Retina, Wills Eye Hospital
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Philadelphia, Pennsylvania, Forente stater, 19141
- Rekruttering
- Vision Research Solutions - the Eye Institute
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Sewickley, Pennsylvania, Forente stater, 15143
- Rekruttering
- Sewickley Eye Group
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South Carolina
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Greenville, South Carolina, Forente stater, 29605
- Rekruttering
- Retina Consultants of Carolina
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Ladson, South Carolina, Forente stater, 29456
- Rekruttering
- Charleston Neuroscience Institute LLC
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Mt. Pleasant, South Carolina, Forente stater, 29464
- Rekruttering
- Charleston Neuroscience Institute, LLC
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West Columbia, South Carolina, Forente stater, 29169
- Rekruttering
- Palmetto Retina Center
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South Dakota
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Rapid City, South Dakota, Forente stater, 57701
- Rekruttering
- Black Hills Regional Eye Institute
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Sioux Falls, South Dakota, Forente stater, 57108
- Rekruttering
- Ophthalmology, LTD - Sioux Falls
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Tennessee
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Nashville, Tennessee, Forente stater, 37203
- Rekruttering
- Tennessee Retina, PC
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Nashville, Tennessee, Forente stater, 37232
- Rekruttering
- Vanderbilt Eye Institute
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Texas
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Abilene, Texas, Forente stater, 79606
- Rekruttering
- Retina Research Institute of Texas
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Austin, Texas, Forente stater, 78705
- Rekruttering
- Austin Research Center for Retina
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Austin, Texas, Forente stater, 78705
- Rekruttering
- Austin Retina Associates
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Austin, Texas, Forente stater, 78750
- Tilbaketrukket
- Austin Clinical Research LLC
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Bellaire, Texas, Forente stater, 77401
- Rekruttering
- Retina Consultants Texas
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Dallas, Texas, Forente stater, 75390
- Rekruttering
- University of Texas Southwestern Medical Center
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Dallas, Texas, Forente stater, 75231
- Rekruttering
- Texas Retina Associates
-
Dallas, Texas, Forente stater, 75231
- Rekruttering
- Retina Foundation of the Southwest
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Fort Worth, Texas, Forente stater, 76132
- Rekruttering
- Star Retina PLLC
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Katy, Texas, Forente stater, 77494
- Rekruttering
- Retina Consultants of Texas
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McAllen, Texas, Forente stater, 78503
- Rekruttering
- Valley Retina Institute, P.A.
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Plano, Texas, Forente stater, 75024
- Fullført
- Red River Research Partners (Formerly AXIS Clinical)
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Round Rock, Texas, Forente stater, 78681
- Rekruttering
- Austin Retina Associates
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San Antonio, Texas, Forente stater, 78240
- Rekruttering
- Medical Center Ophthalmology Associates
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San Antonio, Texas, Forente stater, 78240
- Rekruttering
- Retina Consultants of Texas
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San Antonio, Texas, Forente stater, 78240
- Rekruttering
- Retina Associates of South Texas
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San Antonio, Texas, Forente stater, 78251
- Rekruttering
- Retina Consultants of Texas Brown Retina Institute
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Southlake, Texas, Forente stater, 76092
- Rekruttering
- Retina Center of Texas
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The Woodlands, Texas, Forente stater, 77384
- Rekruttering
- Retina Consultants Texas
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Tyler, Texas, Forente stater, 75703
- Rekruttering
- Tyler Retina Research Institute- Ophthalmology
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Utah
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Salt Lake City, Utah, Forente stater, 84107
- Rekruttering
- Rocky Mountain Retina Consultants
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Salt Lake City, Utah, Forente stater, 84107
- Rekruttering
- Retina Associates Of Utah Retina Specialist
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West Jordan, Utah, Forente stater, 84088
- Rekruttering
- Salt Lake Retina- Ophthalmology
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Vermont
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Burlington, Vermont, Forente stater, 05401
- Rekruttering
- University of Vermont
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Virginia
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Bristol, Virginia, Forente stater, 24201
- Rekruttering
- Southeastern Retina Associates
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Fairfax, Virginia, Forente stater, 22031
- Rekruttering
- Retina Group of Washington
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Lynchburg, Virginia, Forente stater, 24502
- Rekruttering
- Piedmont Eye Center
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Richmond, Virginia, Forente stater, 23226
- Rekruttering
- Virginia Eye Institute
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Richmond, Virginia, Forente stater, 23235
- Fullført
- Retina Institute of Virginia
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Washington
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Spokane, Washington, Forente stater, 99204
- Rekruttering
- Spokane Eye Clinical Research
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West Virginia
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Morgantown, West Virginia, Forente stater, 26506
- Tilbaketrukket
- West Virginia University Eye Institute
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-
-
-
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Créteil, Frankrike, 94010
- Rekruttering
- Centre Hospitalier Intercommunal de Creteil
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Dijon, Frankrike, 21000
- Rekruttering
- Centre Hospitalier Universitaire Francois Mitterrand
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Lille, Frankrike, 59800
- Rekruttering
- Intercard
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Lyon, Frankrike, 69317
- Rekruttering
- Pole Vision Val d'Ouest
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Lyon, Frankrike, 69317
- Rekruttering
- Hopital De La Croix-Rousse
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Marseille, Frankrike, 13008
- Rekruttering
- Centre Monticelli Paradis
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Nantes, Frankrike, 44000
- Rekruttering
- Centre Hospitalier Universitaire de Nantes
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Paris, Frankrike, 75010
- Rekruttering
- Hopital Lariboisiere
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Rouen, Frankrike, 76100
- Rekruttering
- Clinique Mathilde
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Alpes Maritimes
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Nice, Alpes Maritimes, Frankrike, 6002
- Rekruttering
- Centre Hospitalier Universitaire de Nice
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Bouches Du Rhone
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Marseille, Bouches Du Rhone, Frankrike, 13008
- Rekruttering
- Hopital Saint Joseph
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New Aquitaine
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Poitiers, New Aquitaine, Frankrike, 86000
- Rekruttering
- Centre Hospitalier Universitaire De Poitiers
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Occitanie
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Toulouse, Occitanie, Frankrike, 31059
- Rekruttering
- Toulouse University Hospital
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-
-
-
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Ancona, Italia, 60126
- Rekruttering
- Azienda Ospedaliero Universitaria delle Marche
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Milan, Italia, 20157
- Rekruttering
- Universita degli Studi di Milano
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Rome, Italia, 00184
- Rekruttering
- Fondazione G.B.Bietti Per Lo Studio E La Ricerca In Oftalmologia
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Lazio
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Rome, Lazio, Italia, 00168
- Rekruttering
- Fondazione Policlinico Gemelli
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Rome, Lazio, Italia, 00133
- Rekruttering
- University Hospital PTV
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Lombardy
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Milan, Lombardy, Italia, 20123
- Rekruttering
- IRCCS MultiMedica
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Milan, Lombardy, Italia, 20122
- Rekruttering
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
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Milano
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Milan, Milano, Italia, 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, Italia, 50134
- Rekruttering
- Azienda Ospedaliero Universitaria Careggi
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-
-
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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
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Warmian-Masurian Voivodeship
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Olsztyn, Warmian-Masurian Voivodeship, Polen, 10-424
- Rekruttering
- Centrum Diagnostyki I Mikrochirurgii Oka Lens Sp zoo
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-
-
-
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Barcelona, Spania, 08021
- Rekruttering
- Centro de Oftalmologia Barraquer
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Barcelona, Spania, 08035
- Rekruttering
- Instituto de Microcirugia Ocular
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Barcelona, Spania, 8022
- Rekruttering
- Institut Catala De Retina S.L.
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Seville, Spania, 41009
- Rekruttering
- Hospital Universitario Virgen Macarena
-
Valencia, Spania, 46004
- Rekruttering
- Fundacion Aiken De La Comunitat Valenciana
-
Zaragoza, Spania, 50009
- Rekruttering
- Miguel Servet University Hospital
-
Zaragoza, Spania, 50009
- Rekruttering
- Hospital Clinico Universitario Lozano Blesa. IIS Aragon
-
-
Andalusia
-
Córdoba, Andalusia, Spania, 14012
- Rekruttering
- Hospital Arruzafa
-
-
Barcelona
-
L'Hospitalet de Llobregat, Barcelona, Spania, 8907
- Rekruttering
- Bellvitge University Hospital
-
Terrassa, Barcelona, Spania, 08227
- Rekruttering
- Hospital de Terrassa (Consorci Sanitari de Terrassa)
-
-
Valencia
-
Burjassot, Valencia, Spania, 46100
- Rekruttering
- Oftalvist Clinic. IMED Hospital
-
-
-
-
-
Bristol, Storbritannia, BS1 2LX
- Rekruttering
- University Hospitals Bristol NHS Foundation Trust
-
London, Storbritannia, NW1 5QH
- Rekruttering
- Imperial College Healthcare NHS Trust
-
London, Storbritannia, EC1V 2PD
- Rekruttering
- Moorfields Eye Hospital NHS Foundation Trust, Moorfields Eye Hospital
-
Newcastle upon Tyne, Storbritannia, NE1 4LP
- Rekruttering
- The Newcastle Upon Tyne Hospitals NHS Foundation Trust
-
-
Merseyside
-
Liverpool, Merseyside, Storbritannia, L7 8XP
- Rekruttering
- Liverpool University Hospitals NHS Foundation Trust-Royal Liverpool University Hospital, St Paul's Eye Unit-Ophthalmology
-
-
North Yorkshire
-
York, North Yorkshire, Storbritannia, YP31 8HE
- Rekruttering
- York and Scarborough Teaching Hospitals NHS Foundation Trust
-
-
-
-
-
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
-
-
-
-
-
Budapest, Ungarn, 1085
- Rekruttering
- Semmelweis University
-
Budapest, Ungarn, 1133
- Rekruttering
- Budapest Retina Associates
-
-
Baranya
-
Pécs, Baranya, Ungarn, 7621
- Rekruttering
- Ganglion Medical Center
-
-
Csongrad-Csanad
-
Szeged, Csongrad-Csanad, Ungarn, 6720
- Rekruttering
- University Of Szeged
-
-
Hajdú-Bihar
-
Debrecen, Hajdú-Bihar, Ungarn, 4032
- Rekruttering
- University Of Debrecen, Hungary
-
-
-
-
-
Vienna, Østerrike, 1090
- Rekruttering
- Medical University of Vienna
-
Vienna, Østerrike, 1140
- Rekruttering
- VIROS - Vienna Institute for Research in Ocular Surgery
-
-
Styria
-
Graz, Styria, Østerrike, 8036
- Rekruttering
- Medical University Graz
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
50 år til 85 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Pozelimab + Cemdisiran treatment group
Randomized 1:1:1 |
Subcutaneous (SC) injection
Andre navn:
SC injection
Andre navn:
|
|
Eksperimentell: Cemdisiran monotherapy treatment group
Randomized 1:1:1 |
SC injection
Andre navn:
|
|
Placebo komparator: Placebo treatment group
Randomized 1:1:1 |
SC injection |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Veksthastighet (skråning) av total GA -lesjonsområde (mm^2 /år) fra baseline, målt ved Fundus autofluorescence (FAF)
Tidsramme: Til uke 52
|
Til uke 52
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Tap av best korrigert synsskarphet (BCVA) ≥15 bokstaver [tidlig behandling diabetisk retinopati studie (ETDRS)] fra baseline
Tidsramme: I uke 52 og uke 104
|
I uke 52 og uke 104
|
|
Endring fra baseline i kvantitativ visuell skarphet med lav kontrast (LC-QVA)
Tidsramme: I uke 52 og uke 104
|
I uke 52 og uke 104
|
|
Endring fra baseline i lav-luminans lavkontrastkvantitativ synsskarphet (LL-LC-QVA)
Tidsramme: I uke 52 og uke 104
|
I uke 52 og uke 104
|
|
Endring fra baseline i kvantitativ kontrastfølsomhetsfunksjon (QCSF)
Tidsramme: I uke 52 og uke 104
|
I uke 52 og uke 104
|
|
Veksthastighet (skråning) av total GA -lesjonsområde (mm^2 /år) fra baseline målt ved FAF
Tidsramme: Til uke 104
|
Til uke 104
|
|
Konsentrasjoner av total pozelimab i serum
Tidsramme: Til uke 52 og gjennom uke 104
|
Til uke 52 og gjennom uke 104
|
|
Konsentrasjoner av total Cemdisiran i plasma
Tidsramme: Til uke 52 og gjennom uke 104
|
Til uke 52 og gjennom uke 104
|
|
Endring fra baseline i konsentrasjon av total komplementkomponent 5 (C5)
Tidsramme: Til uke 52 og gjennom uke 104
|
Til uke 52 og gjennom uke 104
|
|
Forekomst av antidrug Antistoff (ADA) til pozelimab
Tidsramme: Til uke 52 og gjennom uke 104
|
Til uke 52 og gjennom uke 104
|
|
Størrelsen på Ada til pozelimab
Tidsramme: Til uke 52 og gjennom uke 104
|
Til uke 52 og gjennom uke 104
|
|
Forekomst av ADA til Cemdisiran
Tidsramme: Til uke 52 og gjennom uke 104
|
Til uke 52 og gjennom uke 104
|
|
Størrelsen på Ada til Cemdisiran
Tidsramme: Til uke 52 og gjennom uke 104
|
Til uke 52 og gjennom uke 104
|
|
Forekomst av nøytraliserende antistoff (NAB) til pozelimab
Tidsramme: Til uke 52 og gjennom uke 104
|
Til uke 52 og gjennom uke 104
|
|
Forekomst av behandlingsoppførende bivirkninger (TEAES)
Tidsramme: Gjennom uke 52, 104, 140 og uke 296
|
Gjennom uke 52, 104, 140 og uke 296
|
|
Alvorlighetsgraden av Teaes
Tidsramme: Gjennom uke 52, 104, 140 og uke 296
|
Gjennom uke 52, 104, 140 og uke 296
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Clinical Trial Management, Regeneron Pharmaceuticals
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Hjelpsomme linker
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
30. oktober 2024
Primær fullføring (Antatt)
31. juli 2028
Studiet fullført (Antatt)
9. april 2033
Datoer for studieregistrering
Først innsendt
2. august 2024
Først innsendt som oppfylte QC-kriteriene
2. august 2024
Først lagt ut (Faktiske)
7. august 2024
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
5. november 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
3. november 2026
Sist bekreftet
1. november 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- R3918-AMD-2326
- 2023 (U.S. NIH-stipend/kontrakt)
- 2023-509547-27-00 (Ctis)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (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.
Tilgangskriterier for IPD-deling
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 Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ICF
- ANALYTIC_CODE
- CSR
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .