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A Study Investigating Subcutaneously Administered Pozelimab in Combination With Cemdisiran or Cemdisiran Alone in Adult Participants With Geographic Atrophy
Sponsor: Regeneron Pharmaceuticals
Summary
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)
Official title: A Multicenter, Randomized, Double-Masked, Placebo-Controlled Phase 3 Study of the Efficacy, Safety, and Tolerability of Subcutaneously Administered Pozelimab in Combination With Cemdisiran or Cemdisiran Alone in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration
Key Details
Gender
All
Age Range
50 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
975
Start Date
2024-10-30
Completion Date
2032-05-21
Last Updated
2026-04-09
Healthy Volunteers
No
Interventions
Pozelimab
Subcutaneous (SC) injection
Cemdisiran
SC injection
Placebo
SC injection
Locations (216)
Barnet Dulaney Perkins Eye Center-Ophthamalogy
Chandler, Arizona, United States
Barnet Dulaney Perkins Eye Center
Phoenix, Arizona, United States
Associated Retina Consultants
Phoenix, Arizona, United States
Retinal Research Institute
Phoenix, Arizona, United States
Retina Macula Institute of Arizona
Scottsdale, Arizona, United States
Retina Associates of Tuscan
Tucson, Arizona, United States
Retina Partners of Northwest Arkansas, PLLC
Springdale, Arkansas, United States
Retina Vitreous Associates Medical Group
Beverly Hills, California, United States
Retina Specialists of Beverly Hills- Department of Ophthalmology
Beverly Hills, California, United States
The Retina Partners
Encino, California, United States
Eye Medical Center of Fresno
Fresno, California, United States
Retina Consultants of Orange County
Fullerton, California, United States
Salehi Retina Institute dba Retina Associates of Southern California
Huntington Beach, California, United States
University of California Irvine
Irvine, California, United States
University of California San Diego, Jacobs Retina Center
La Jolla, California, United States
South Coast Retina Center
Long Beach, California, United States
American Institute of Research
Los Angeles, California, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States
Jules Stein Eye Institute in David Geffen School of Medicine at Ucla
Los Angeles, California, United States
Retinal Consultants Medical Group Inc Modesto
Modesto, California, United States
Northern California Retina Vitreous Associates Medical Group, Inc.
Mountain View, California, United States
California Retina Consultants
Oxnard, California, United States
Desert Retina Consultants
Palm Desert, California, United States
California Eye Specialists Medical Group Inc.
Pasadena, California, United States
Retina Consultants San Diego
Poway, California, United States
California Eye Specialists Medical Group, Inc.
Redlands, California, United States
Optic Eye Care
Rowland Heights, California, United States
UC Davis Health Eye Center
Sacramento, California, United States
Vrmg Inc
Sacramento, California, United States
Retinal Consultants Medical Group (RCMG) - Greenback Lane Retina Center
Sacramento, California, United States
West Coast Retina Medical Group, Inc.
San Francisco, California, United States
Orange County Retina Medical Group
Santa Ana, California, United States
Macula Retina Vitreous Research Institute
Torrance, California, United States
University of Colorado
Aurora, Colorado, United States
Retina Consultants of Southern Colorado
Colorado Springs, Colorado, United States
Retina Specialists of Colorado - Denver
Denver, Colorado, United States
Southwest Retina Research Center
Durango, Colorado, United States
Colorado Retina - Lakewood
Lakewood, Colorado, United States
Eye care Center of Northern Colorado doing business as Advanced Vision Research Institute
Longmont, Colorado, United States
Retina Group of New England
Waterford, Connecticut, United States
Advanced Retina Institute-Ophthalmology
Bonita Springs, Florida, United States
Advanced Research
Coral Springs, Florida, United States
Retina Group of Florida
Fort Lauderdale, Florida, United States
National Ophthalmic Research Institute
Fort Myers, Florida, United States
ClearVista Clinical Research, Retina Center Tampa Bay
Hudson, Florida, United States
Florida Retina Institute, Jacksonville Perimeter Park- Ophthalmology
Jacksonville, Florida, United States
Florida Retina Consultants
Lakeland, Florida, United States
Bascom Palmer Eye Institute
Naples, Florida, United States
Florida Retina Institute - Orlando
Orlando, Florida, United States
Retina Care Specialists
Palm Beach Gardens, Florida, United States
Eye Associates of Pinellas
Pinellas Park, Florida, United States
Retina Group of Florida, RAS-Sarasota Retina Center-Ophthalmology
Sarasota, Florida, United States
Retina Vitreous Associates of Florida Saint Petersburg
St. Petersburg, Florida, United States
University of South Florida Ophthalmology
Tampa, Florida, United States
Center for Retina and Macular Disease
Winter Haven, Florida, United States
Southeast Retina Center
Augusta, Georgia, United States
Georgia Retina - Marietta
Marietta, Georgia, United States
University of Illinois at Chicago
Chicago, Illinois, United States
Retinal Vitreal Consultants
Chicago, Illinois, United States
The University of Chicago
Chicago, Illinois, United States
University Retina and Macula Associates PC - Lemont
Lemont, Illinois, United States
Illinois Retina Associates
Oak Park, Illinois, United States
Springfield Clinic Main Campus East
Springfield, Illinois, United States
Retina Associates, LLC
Lenexa, Kansas, United States
University of Louisville
Louisville, Kentucky, United States
Retina Associates New Orleans
Metairie, Louisiana, United States
Ross Davis Retina
Metairie, Louisiana, United States
Ochsner Health
New Orleans, Louisiana, United States
Eye Assoc. of NE LA dba Haik Humble Eye Ctr
West Monroe, Louisiana, United States
Eye Associates of Northeast Louisiana dba Haik Humble Eye Center
West Monroe, Louisiana, United States
The Retina Care Center
Baltimore, Maryland, United States
The Retina Group of Washington
Chevy Chase, Maryland, United States
Cumberland Valley Retina Consultants-Ophthalmology
Hagerstown, Maryland, United States
Mid Atlantic Retina Specialist
Hagerstown, Maryland, United States
Massachusetts Eye And Ear Infirmary
Boston, Massachusetts, United States
Opthalmic Consultants of Boston
Boston, Massachusetts, United States
New England Retina Consultants, PC
Springfield, Massachusetts, United States
Retina Associates of Michigan
Grand Blanc, Michigan, United States
Mississippi Retina Associates
Madison, Mississippi, United States
Deep Blue Retina Clinical Research PLLC
Southaven, Mississippi, United States
Retina Research Institute, LLC
St Louis, Missouri, United States
Mid Atlantic Retina - Cherry Hill
Cherry Hill, New Jersey, United States
New Jersey Retina
Teaneck, New Jersey, United States
New Jersey Retina
Toms River, New Jersey, United States
Vision Research Center at Eye Associates of New Mexico
Albuquerque, New Mexico, United States
University of New Mexico, HSC
Albuquerque, New Mexico, United States
Sight MD
Brentwood, New York, United States
Retina Vitreous Surgeons of Central New York, PC
Liverpool, New York, United States
MaculaCare, PLLC
New York, New York, United States
New York Ear & Eye- East 85th
New York, New York, United States
Northwell Health- Manhattan, Ear, Eye and Throat Hospital- Ophthalmology
New York, New York, United States
Retina Associates of New York, Upper East Side
New York, New York, United States
Seeta Eye center
Poughkeepsie, New York, United States
Western Carolina Retinal Associates
Asheville, North Carolina, United States
NC Retina Associates
Cary, North Carolina, United States
Graystone Eye
Hickory, North Carolina, United States
North Carolina Retina Associates
Wake Forest, North Carolina, United States
Piedmont Retina Specialist
Winston-Salem, North Carolina, United States
Cincinnati Eye Institute
Cincinnati, Ohio, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
The Ohio State University
Columbus, Ohio, United States
Midwest Retina, Inc
Dublin, Ohio, United States
Retina Vitreous Center - Edmond
Edmond, Oklahoma, United States
Tulsa Retina Consultants
Tulsa, Oklahoma, United States
Verum Research LLC
Eugene, Oregon, United States
Retina Northwest, The Highlands Building
Portland, Oregon, United States
EyeHealth Northwest
Portland, Oregon, United States
OHSU-Casey Eye Institute, Marquam Hill-Ophthalmology
Portland, Oregon, United States
Cascade Medical Research Institute LLC
Springfield, Oregon, United States
Mid Atlantic Retina
Bethlehem, Pennsylvania, United States
Erie Retinal Surgery & Erie Retina Research
Erie, Pennsylvania, United States
Mid Atlantic Retina, Wills Eye Hospital
Philadelphia, Pennsylvania, United States
Vision Research Solutions - the Eye Institute
Philadelphia, Pennsylvania, United States
Sewickley Eye Group
Sewickley, Pennsylvania, United States
Retina Consultants of Carolina
Greenville, South Carolina, United States
Charleston Neuroscience Institute LLC
Ladson, South Carolina, United States
Charleston Neuroscience Institute, LLC
Mt. Pleasant, South Carolina, United States
Palmetto Retina Center
West Columbia, South Carolina, United States
Black Hills Regional Eye Institute
Rapid City, South Dakota, United States
Tennessee Retina, PC
Nashville, Tennessee, United States
Vanderbilt Eye Institute
Nashville, Tennessee, United States
Retina Research Institute of Texas
Abilene, Texas, United States
Austin Research Center for Retina
Austin, Texas, United States
Austin Retina Associates
Austin, Texas, United States
Austin Clinical Research LLC
Austin, Texas, United States
Retina Consultants Texas
Bellaire, Texas, United States
Star Retina PLLC
Burleson, Texas, United States
Retina Foundation of the Southwest
Dallas, Texas, United States
Texas Retina Associates
Dallas, Texas, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Retina Consultants of Texas
Katy, Texas, United States
Valley Retina Institute, P.A.
McAllen, Texas, United States
Red River Research Partners (Formerly AXIS Clinical)
Plano, Texas, United States
Austin Retina Associates
Round Rock, Texas, United States
Medical Center Ophthalmology Associates
San Antonio, Texas, United States
Retina Associates of South Texas
San Antonio, Texas, United States
Retina Consultants of Texas
San Antonio, Texas, United States
Retina Consultants of Texas Brown Retina Institute
San Antonio, Texas, United States
Retina Center of Texas
Southlake, Texas, United States
Retina Consultants Texas
The Woodlands, Texas, United States
Tyler Retina Research Institute- Ophthalmology
Tyler, Texas, United States
Retina Associates Of Utah Retina Specialist
Salt Lake City, Utah, United States
Rocky Mountain Retina Consultants
Salt Lake City, Utah, United States
Salt Lake Retina- Ophthalmology
West Jordan, Utah, United States
University of Vermont
Burlington, Vermont, United States
Southeastern Retina Associates
Bristol, Virginia, United States
Retina Group of Washington
Fairfax, Virginia, United States
Piedmont Eye Center
Lynchburg, Virginia, United States
Virginia Eye Institute
Richmond, Virginia, United States
Retina Institute of Virginia
Richmond, Virginia, United States
Spokane Eye Clinical Research
Spokane, Washington, United States
West Virginia University Eye Institute
Morgantown, West Virginia, United States
Medical University Graz
Graz, Styria, Austria
Medical University of Vienna
Vienna, Austria
VIROS - Vienna Institute for Research in Ocular Surgery
Vienna, Austria
Retina Centre of Ottawa - Department of Ophthalmology
Ottawa, Ontario, Canada
Centre Hospitalier Universitaire de Quebec Universite Laval
Québec, Canada
Centre Hospitalier Universitaire de Nice
Nice, Alpes Maritimes, France
Hopital Saint Joseph
Marseille, Bouches Du Rhone, France
Centre Hospitalier Universitaire De Poitiers
Poitiers, Nouvelle-Aquitaine, France
Toulouse University Hospital
Toulouse, Occitanie, France
Centre Hospitalier Intercommunal de Creteil
Créteil, France
Centre Hospitalier Universitaire Francois Mitterrand
Dijon, France
Hopital De La Croix-Rousse
Lyon, France
Pole Vision Val d'Ouest
Lyon, France
Centre Monticelli Paradis
Marseille, France
Centre Hospitalier Universitaire de Nantes
Nantes, France
Hopital Lariboisiere
Paris, France
University of Ulm
Ulm, Baden-Wurttemberg, Germany
Charite - Universitaetsmedizin Berlin
Berlin, Brandenburg, Germany
Augenzentrum Frankfurt
Frankfurt am Main, Hesse, Germany
Universitaetsklinikum Marburg, Klinik fuer Augenheilkunde
Marburg, Hesse, Germany
Dietrich Bonhoeffer Klinikum
Neubrandenburg, Mecklenburg-Vorpommern, Germany
Universitatsklinikum Bonn
Bonn, North Rhine-Westphalia, Germany
Klinik fur Augenheilkunde Universitatsklinikum Dusseldorf
Düsseldorf, North Rhine-Westphalia, Germany
Universitaetsklinikum Muenster
Münster, North Rhine-Westphalia, Germany
Klinikum Ludwigshafen Augenklinik
Ludwigshafen am Rhein, Rhineland-Palatinate, Germany
Saarland University Medical Center
Homburg, Saarland, Germany
Knappschaftsklinikum Saar GmbH- Eye Clnic Sulzbach
Sulzbach, Saarland, Germany
University Hospital Hamburg Eppendorf
Hamburg, Germany
University Medical Center of the Johannes Gutenberg-University Mainz
Mainz, Germany
St. Franziskus-Hospital
Münster, Germany
Ganglion Medical Center
Pécs, Baranya, Hungary
University Of Szeged
Szeged, Csongrad-Csanad, Hungary
University Of Debrecen, Hungary
Debrecen, Hajdú-Bihar, Hungary
Semmelweis University
Budapest, Hungary
Budapest Retina Associates
Budapest, Hungary
University Hospital PTV
Rome, Lazio, Italy
Fondazione Policlinico Gemelli
Rome, Lazio, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Lombardy, Italy
IRCCS MultiMedica
Milan, Lombardy, Italy
Ospedale San Raffaele (HSR) - Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS)
Milan, Milano, Italy
Azienda Ospedaliero Universitaria Careggi
Florence, Tuscany, Italy
Azienda Ospedaliero Universitaria delle Marche
Ancona, Italy
Universita degli Studi di Milano
Milan, Italy
Fondazione G.B.Bietti Per Lo Studio E La Ricerca In Oftalmologia
Rome, Italy
Oftalmika Sp. z o.o.
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Caminomed
Tarnowskie Góry, Silesian Voivodeship, Poland
Centrum Diagnostyki I Mikrochirurgii Oka Lens Sp zoo
Olsztyn, Warmian-Masurian Voivodeship, Poland
Hospital Arruzafa
Córdoba, Andalusia, Spain
Bellvitge University Hospital
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital de Terrassa (Consorci Sanitari de Terrassa)
Terrassa, Barcelona, Spain
Oftalvist Clinic. IMED Hospital
Burjassot, Valencia, Spain
Centro de Oftalmologia Barraquer
Barcelona, Spain
Instituto de Microcirugia Ocular
Barcelona, Spain
Institut Catala De Retina S.L.
Barcelona, Spain
Hospital Universitario Virgen Macarena
Seville, Spain
Fundacion Aiken De La Comunitat Valenciana
Valencia, Spain
Hospital Clinico Universitario Lozano Blesa. IIS Aragon
Zaragoza, Spain
Miguel Servet University Hospital
Zaragoza, Spain
Liverpool University Hospitals NHS Foundation Trust-Royal Liverpool University Hospital, St Paul's Eye Unit-Ophthalmology
Liverpool, Merseyside, United Kingdom
York and Scarborough Teaching Hospitals NHS Foundation Trust
York, North Yorkshire, United Kingdom
University Hospitals Bristol NHS Foundation Trust
Bristol, United Kingdom
Moorfields Eye Hospital NHS Foundation Trust, Moorfields Eye Hospital
London, United Kingdom
Imperial College Healthcare NHS Trust
London, United Kingdom
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, United Kingdom