A Study Investigating Subcutaneously Administered Pozelimab in Combination With Cemdisiran or Cemdisiran Alone in Adult Participants With Geographic Atrophy (SIENNA)

May 25, 2026 updated by: Regeneron Pharmaceuticals

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

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)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

975

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Clinical Trials Administrator
Phone Number: 844-734-6643
Email: clinicaltrials@regeneron.com

Study Locations

Austria
- - Vienna, Austria, 1090
    - Recruiting
    - Medical University of Vienna
  - Vienna, Austria, 1140
    - Recruiting
    - VIROS - Vienna Institute for Research in Ocular Surgery
- Styria
  - Graz, Styria, Austria, 8036
    - Recruiting
    - Medical University Graz
Canada
- - Québec, Canada, G1S 4L8
    - Recruiting
    - Centre Hospitalier Universitaire de Quebec Universite Laval
- Ontario
  - Ottawa, Ontario, Canada, K2B 7E9
    - Recruiting
    - Retina Centre of Ottawa - Department of Ophthalmology
France
- - Créteil, France, 94010
    - Recruiting
    - Centre Hospitalier Intercommunal de Créteil
  - Dijon, France, 21000
    - Recruiting
    - Centre Hospitalier Universitaire Francois Mitterrand
  - Lyon, France, 69317
    - Recruiting
    - Hopital De La Croix-Rousse
  - Lyon, France, 69317
    - Recruiting
    - Pole Vision Val d'Ouest
  - Marseille, France, 13008
    - Recruiting
    - Centre Monticelli Paradis
  - Nantes, France, 44000
    - Recruiting
    - Centre Hospitalier Universitaire de Nantes
  - Paris, France, 75010
    - Recruiting
    - Hopital Lariboisiere
- Alpes Maritimes
  - Nice, Alpes Maritimes, France, 6002
    - Recruiting
    - Centre Hospitalier Universitaire de Nice
- Bouches Du Rhone
  - Marseille, Bouches Du Rhone, France, 13008
    - Recruiting
    - Hopital Saint Joseph
- New Aquitaine
  - Poitiers, New Aquitaine, France, 86000
    - Recruiting
    - Centre Hospitalier Universitaire De Poitiers
- Occitanie
  - Toulouse, Occitanie, France, 31059
    - Recruiting
    - Toulouse University Hospital
Germany
- - Hamburg, Germany, 20246
    - Recruiting
    - University Hospital Hamburg Eppendorf
  - Mainz, Germany, 55131
    - Recruiting
    - University Medical Center of the Johannes Gutenberg-University Mainz
  - Münster, Germany, 48145
    - Recruiting
    - St. Franziskus-Hospital
- Baden-Wurttemberg
  - Ulm, Baden-Wurttemberg, Germany, 89081
    - Recruiting
    - University of Ulm
- Brandenburg
  - Berlin, Brandenburg, Germany, 12203
    - Recruiting
    - Charite - Universitaetsmedizin Berlin
- Hesse
  - Frankfurt am Main, Hesse, Germany, 60549
    - Recruiting
    - Augenzentrum Frankfurt
  - Marburg, Hesse, Germany, 35043
    - Recruiting
    - Universitaetsklinikum Marburg, Klinik fuer Augenheilkunde
- Mecklenburg-Vorpommern
  - Neubrandenburg, Mecklenburg-Vorpommern, Germany, 17036
    - Recruiting
    - Dietrich Bonhoeffer Klinikum
- North Rhine-Westphalia
  - Bonn, North Rhine-Westphalia, Germany, 53127
    - Recruiting
    - Universitatsklinikum Bonn
  - Düsseldorf, North Rhine-Westphalia, Germany, 40225
    - Recruiting
    - Klinik fur Augenheilkunde Universitatsklinikum Dusseldorf
  - Münster, North Rhine-Westphalia, Germany, 48149
    - Recruiting
    - Universitaetsklinikum Muenster
- Rhineland-Palatinate
  - Ludwigshafen am Rhein, Rhineland-Palatinate, Germany, 67063
    - Recruiting
    - Klinikum Ludwigshafen Augenklinik
- Saarland
  - Homburg, Saarland, Germany, 66421
    - Recruiting
    - Saarland University Medical Center
  - Sulzbach, Saarland, Germany, 66280
    - Recruiting
    - Knappschaftsklinikum Saar GmbH- Eye Clnic Sulzbach
Hungary
- - Budapest, Hungary, 1085
    - Recruiting
    - Semmelweis University
  - Budapest, Hungary, 1133
    - Recruiting
    - Budapest Retina Associates
- Baranya
  - Pécs, Baranya, Hungary, 7621
    - Recruiting
    - Ganglion Medical Center
- Csongrad-Csanad
  - Szeged, Csongrad-Csanad, Hungary, 6720
    - Recruiting
    - University of Szeged
- Hajdú-Bihar
  - Debrecen, Hajdú-Bihar, Hungary, 4032
    - Recruiting
    - University Of Debrecen, Hungary
Italy
- - Ancona, Italy, 60126
    - Recruiting
    - Azienda Ospedaliero Universitaria delle Marche
  - Milan, Italy, 20157
    - Recruiting
    - Universita degli Studi di Milano
  - Rome, Italy, 00184
    - Recruiting
    - Fondazione G.B.Bietti Per Lo Studio E La Ricerca In Oftalmologia
- Lazio
  - Rome, Lazio, Italy, 00168
    - Recruiting
    - Fondazione Policlinico Gemelli
  - Rome, Lazio, Italy, 00133
    - Recruiting
    - University Hospital PTV
- Lombardy
  - Milan, Lombardy, Italy, 20123
    - Recruiting
    - IRCCS MultiMedica
  - Milan, Lombardy, Italy, 20122
    - Recruiting
    - Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
- Milano
  - Milan, Milano, Italy, 20132
    - Recruiting
    - Ospedale San Raffaele (HSR) - Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS)
- Tuscany
  - Florence, Tuscany, Italy, 50134
    - Recruiting
    - Azienda Ospedaliero Universitaria Careggi
Poland
- Kuyavian-Pomeranian Voivodeship
  - Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-631
    - Recruiting
    - Oftalmika Sp. z o.o.
- Silesian Voivodeship
  - Tarnowskie Góry, Silesian Voivodeship, Poland, 42-600
    - Recruiting
    - Caminomed
- Warmian-Masurian Voivodeship
  - Olsztyn, Warmian-Masurian Voivodeship, Poland, 10-424
    - Recruiting
    - Centrum Diagnostyki I Mikrochirurgii Oka Lens Sp zoo
Spain
- - Barcelona, Spain, 08021
    - Recruiting
    - Centro de Oftalmologia Barraquer
  - Barcelona, Spain, 08035
    - Recruiting
    - Instituto de Microcirugia Ocular
  - Barcelona, Spain, 8022
    - Recruiting
    - Institut Catala De Retina S.L.
  - Seville, Spain, 41009
    - Recruiting
    - Hospital Universitario Virgen Macarena
  - Valencia, Spain, 46004
    - Recruiting
    - Fundacion Aiken De La Comunitat Valenciana
  - Zaragoza, Spain, 50009
    - Recruiting
    - Miguel Servet University Hospital
  - Zaragoza, Spain, 50009
    - Recruiting
    - Hospital Clinico Universitario Lozano Blesa. IIS Aragon
- Andalusia
  - Córdoba, Andalusia, Spain, 14012
    - Recruiting
    - Hospital Arruzafa
- Barcelona
  - L'Hospitalet de Llobregat, Barcelona, Spain, 8907
    - Recruiting
    - Bellvitge University Hospital
  - Terrassa, Barcelona, Spain, 08227
    - Recruiting
    - Hospital de Terrassa (Consorci Sanitari de Terrassa)
- Valencia
  - Burjassot, Valencia, Spain, 46100
    - Recruiting
    - Oftalvist Clinic. IMED Hospital
United Kingdom
- - Bristol, United Kingdom, BS1 2LX
    - Recruiting
    - University Hospitals Bristol NHS Foundation Trust
  - London, United Kingdom, NW1 5QH
    - Recruiting
    - Imperial College Healthcare NHS Trust
  - London, United Kingdom, EC1V 2PD
    - Recruiting
    - Moorfields Eye Hospital NHS Foundation Trust, Moorfields Eye Hospital
  - Newcastle upon Tyne, United Kingdom, NE1 4LP
    - Recruiting
    - The Newcastle Upon Tyne Hospitals NHS Foundation Trust
- Merseyside
  - Liverpool, Merseyside, United Kingdom, L7 8XP
    - Recruiting
    - Liverpool University Hospitals NHS Foundation Trust-Royal Liverpool University Hospital, St Paul's Eye Unit-Ophthalmology
- North Yorkshire
  - York, North Yorkshire, United Kingdom, YP31 8HE
    - Recruiting
    - York and Scarborough Teaching Hospitals NHS Foundation Trust
United States
- Arizona
  - Chandler, Arizona, United States, 85224
    - Recruiting
    - Barnet Dulaney Perkins Eye Center-Ophthamalogy
  - Phoenix, Arizona, United States, 85053
    - Recruiting
    - Retinal Research Institute
  - Phoenix, Arizona, United States, 85020
    - Recruiting
    - Associated Retina Consultants
  - Phoenix, Arizona, United States, 85016
    - Recruiting
    - Barnet Dulaney Perkins Eye Center
  - Scottsdale, Arizona, United States, 85255
    - Recruiting
    - Retina Macula Institute of Arizona
  - Tucson, Arizona, United States, 85712
    - Recruiting
    - Retina Associates of Tuscan
- Arkansas
  - Springdale, Arkansas, United States, 72764
    - Recruiting
    - Retina Partners of Northwest Arkansas, PLLC
- California
  - Beverly Hills, California, United States, 90211
    - Recruiting
    - Retina Vitreous Associates Medical Group
  - Beverly Hills, California, United States, 90212
    - Recruiting
    - Retina Specialists of Beverly Hills- Department of Ophthalmology
  - Encino, California, United States, 91436
    - Recruiting
    - The Retina Partners
  - Fresno, California, United States, 93720
    - Recruiting
    - Eye Medical Center of Fresno
  - Fullerton, California, United States, 92835
    - Completed
    - Retina Consultants of Orange County
  - Huntington Beach, California, United States, 92647
    - Recruiting
    - Salehi Retina Institute dba Retina Associates of Southern California
  - Irvine, California, United States, 92617
    - Recruiting
    - University of California Irvine
  - La Jolla, California, United States, 92093
    - Recruiting
    - University of California San Diego, Jacobs Retina Center
  - Long Beach, California, United States, 90807
    - Recruiting
    - South Coast Retina Center
  - Los Angeles, California, United States, 90027
    - Recruiting
    - Kaiser Permanente Los Angeles Medical Center
  - Los Angeles, California, United States, 90017
    - Recruiting
    - American Institute of Research
  - Los Angeles, California, United States, 90095
    - Recruiting
    - Jules Stein Eye Institute in David Geffen School of Medicine at Ucla
  - Modesto, California, United States, 95356
    - Recruiting
    - Retinal Consultants Medical Group Inc Modesto
  - Mountain View, California, United States, 94040
    - Recruiting
    - Northern California Retina Vitreous Associates Medical Group, Inc.
  - Oxnard, California, United States, 93036
    - Recruiting
    - California Retina Consultants
  - Palm Desert, California, United States, 92211
    - Withdrawn
    - Desert Retina Consultants
  - Pasadena, California, United States, 91107
    - Recruiting
    - California Eye Specialists Medical Group Inc.
  - Poway, California, United States, 92064
    - Recruiting
    - Retina Consultants San Diego
  - Redlands, California, United States, 92373
    - Recruiting
    - California Eye Specialists Medical Group, Inc.
  - Rowland Heights, California, United States, 91748
    - Recruiting
    - Optic Eye Care
  - Sacramento, California, United States, 95817
    - Recruiting
    - UC Davis Health Eye Center
  - Sacramento, California, United States, 95825
    - Recruiting
    - Vrmg Inc
  - Sacramento, California, United States, 95841
    - Recruiting
    - Retinal Consultants Medical Group (RCMG) - Greenback Lane Retina Center
  - San Francisco, California, United States, 94109
    - Recruiting
    - West Coast Retina Medical Group, Inc.
  - Santa Ana, California, United States, 92705
    - Recruiting
    - Orange County Retina Medical Group
  - Torrance, California, United States, 90503
    - Recruiting
    - Macula Retina Vitreous Research Institute
- Colorado
  - Aurora, Colorado, United States, 80045
    - Recruiting
    - University of Colorado
  - Colorado Springs, Colorado, United States, 80909
    - Recruiting
    - Retina Consultants of Southern Colorado
  - Denver, Colorado, United States, 80222
    - Recruiting
    - Retina Specialists of Colorado - Denver
  - Durango, Colorado, United States, 81303
    - Recruiting
    - Southwest Retina Research Center
  - Lakewood, Colorado, United States, 80228
    - Recruiting
    - Colorado Retina - Lakewood
  - Longmont, Colorado, United States, 80503
    - Recruiting
    - Eye care Center of Northern Colorado doing business as Advanced Vision Research Institute
- Connecticut
  - Waterford, Connecticut, United States, 06385
    - Terminated
    - Retina Group of New England
- Florida
  - Bonita Springs, Florida, United States, 34134
    - Recruiting
    - Advanced Retina Institute-Ophthalmology
  - Coral Springs, Florida, United States, 33067
    - Recruiting
    - Advanced Research
  - Fort Lauderdale, Florida, United States, 33308
    - Recruiting
    - Retina Group of Florida
  - Fort Myers, Florida, United States, 33912
    - Withdrawn
    - National Ophthalmic Research Institute
  - Hudson, Florida, United States, 34667
    - Recruiting
    - ClearVista Clinical Research, Retina Center Tampa Bay
  - Jacksonville, Florida, United States, 32216
    - Recruiting
    - Florida Retina Institute, Jacksonville Perimeter Park- Ophthalmology
  - Lakeland, Florida, United States, 33805
    - Recruiting
    - Florida Retina Consultants
  - Naples, Florida, United States, 34103
    - Recruiting
    - Bascom Palmer Eye Institute
  - Orlando, Florida, United States, 32806
    - Recruiting
    - Florida Retina Institute - Orlando
  - Palm Beach Gardens, Florida, United States, 33410
    - Recruiting
    - Retina Care Specialists
  - Pinellas Park, Florida, United States, 33782
    - Recruiting
    - Eye Associates of Pinellas
  - Sarasota, Florida, United States, 34232
    - Recruiting
    - Retina Group of Florida, RAS-Sarasota Retina Center-Ophthalmology
  - St. Petersburg, Florida, United States, 33711
    - Recruiting
    - Retina Vitreous Associates of Florida Saint Petersburg
  - Tampa, Florida, United States, 33612
    - Recruiting
    - University of South Florida Ophthalmology
  - Winter Haven, Florida, United States, 33880
    - Recruiting
    - Center for Retina and Macular Disease
- Georgia
  - Augusta, Georgia, United States, 30909
    - Recruiting
    - Southeast Retina Center
  - Marietta, Georgia, United States, 30060
    - Recruiting
    - Georgia Retina - Marietta
- Illinois
  - Chicago, Illinois, United States, 60612
    - Recruiting
    - University of Illinois at Chicago
  - Chicago, Illinois, United States, 60637
    - Recruiting
    - The University of Chicago
  - Chicago, Illinois, United States, 60616
    - Recruiting
    - Retinal Vitreal Consultants
  - Lemont, Illinois, United States, 60439
    - Recruiting
    - University Retina and Macula Associates PC - Lemont
  - Oak Park, Illinois, United States, 60304
    - Recruiting
    - Illinois Retina Associates
  - Springfield, Illinois, United States, 62703
    - Recruiting
    - Springfield Clinic Main Campus East
- Kansas
  - Lenexa, Kansas, United States, 66215
    - Recruiting
    - Retina Associates, LLC
- Kentucky
  - Louisville, Kentucky, United States, 40202
    - Recruiting
    - University of Louisville
- Louisiana
  - Metairie, Louisiana, United States, 70006
    - Recruiting
    - Retina Associates New Orleans
  - Metairie, Louisiana, United States, 70006
    - Recruiting
    - Ross Davis Retina
  - New Orleans, Louisiana, United States, 70121
    - Recruiting
    - Ochsner Health
  - West Monroe, Louisiana, United States, 71291
    - Recruiting
    - Eye Associates of Northeast Louisiana dba Haik Humble Eye Center
  - West Monroe, Louisiana, United States, 71291
    - Recruiting
    - Eye Assoc. of NE LA dba Haik Humble Eye Ctr
- Maryland
  - Baltimore, Maryland, United States, 21209
    - Recruiting
    - The Retina Care Center
  - Chevy Chase, Maryland, United States, 20815
    - Recruiting
    - The Retina Group of Washington
  - Hagerstown, Maryland, United States, 21740
    - Recruiting
    - Mid Atlantic Retina Specialist
  - Hagerstown, Maryland, United States, 21740
    - Recruiting
    - Cumberland Valley Retina Consultants-Ophthalmology
- Massachusetts
  - Boston, Massachusetts, United States, 02114
    - Recruiting
    - Massachusetts Eye and Ear Infirmary
  - Boston, Massachusetts, United States, 02114
    - Recruiting
    - Opthalmic Consultants of Boston
  - Springfield, Massachusetts, United States, 01107
    - Recruiting
    - New England Retina Consultants, PC
- Michigan
  - Grand Blanc, Michigan, United States, 48439
    - Recruiting
    - Retina Associates of Michigan
- Mississippi
  - Madison, Mississippi, United States, 39110
    - Recruiting
    - Mississippi Retina Associates
  - Southaven, Mississippi, United States, 38671
    - Recruiting
    - Deep Blue Retina Clinical Research PLLC
- Missouri
  - St Louis, Missouri, United States, 63144
    - Recruiting
    - Retina Research Institute, LLC
- New Jersey
  - Cherry Hill, New Jersey, United States, 08034
    - Recruiting
    - Mid Atlantic Retina - Cherry Hill
  - Teaneck, New Jersey, United States, 07666
    - Recruiting
    - New Jersey Retina
  - Toms River, New Jersey, United States, 08755
    - Recruiting
    - New Jersey Retina
- New Mexico
  - Albuquerque, New Mexico, United States, 87109
    - Recruiting
    - Vision Research Center at Eye Associates of New Mexico
  - Albuquerque, New Mexico, United States, 87131
    - Recruiting
    - University of New Mexico, HSC
- New York
  - Brentwood, New York, United States, 11717
    - Recruiting
    - Sight MD
  - Liverpool, New York, United States, 13088
    - Recruiting
    - Retina Vitreous Surgeons of Central New York, PC
  - New York, New York, United States, 10021
    - Recruiting
    - MaculaCare, PLLC
  - New York, New York, United States, 10028
    - Recruiting
    - New York Ear & Eye- East 85th
  - New York, New York, United States, 10075
    - Recruiting
    - Retina Associates of New York, Upper East Side
  - New York, New York, United States, 10065
    - Recruiting
    - Northwell Health- Manhattan, Ear, Eye and Throat Hospital- Ophthalmology
  - Poughkeepsie, New York, United States, 12603
    - Recruiting
    - Seeta Eye center
- North Carolina
  - Asheville, North Carolina, United States, 28803
    - Recruiting
    - Western Carolina Retinal Associates
  - Cary, North Carolina, United States, 27511
    - Recruiting
    - NC Retina Associates
  - Hickory, North Carolina, United States, 28602
    - Recruiting
    - Graystone Eye
  - Wake Forest, North Carolina, United States, 27587
    - Recruiting
    - North Carolina Retina Associates
  - Winston-Salem, North Carolina, United States, 27103
    - Recruiting
    - Piedmont Retina Specialist
- Ohio
  - Cincinnati, Ohio, United States, 45242
    - Recruiting
    - Cincinnati Eye Institute
  - Cleveland, Ohio, United States, 44106
    - Recruiting
    - University Hospitals Cleveland Medical Center
  - Columbus, Ohio, United States, 43212
    - Recruiting
    - The Ohio State University
  - Dublin, Ohio, United States, 43016
    - Recruiting
    - Midwest Retina, Inc
- Oklahoma
  - Edmond, Oklahoma, United States, 73013
    - Recruiting
    - Retina Vitreous Center - Edmond
  - Tulsa, Oklahoma, United States, 74114
    - Recruiting
    - Tulsa Retina Consultants
- Oregon
  - Eugene, Oregon, United States, 97401
    - Recruiting
    - Verum Research LLC
  - Portland, Oregon, United States, 97225
    - Recruiting
    - EyeHealth Northwest
  - Portland, Oregon, United States, 97221
    - Recruiting
    - Retina Northwest, The Highlands Building
  - Portland, Oregon, United States, 97239
    - Recruiting
    - OHSU-Casey Eye Institute, Marquam Hill-Ophthalmology
  - Springfield, Oregon, United States, 97477
    - Recruiting
    - Cascade Medical Research Institute LLC
- Pennsylvania
  - Bethlehem, Pennsylvania, United States, 18017
    - Recruiting
    - Mid Atlantic Retina
  - Erie, Pennsylvania, United States, 16507
    - Recruiting
    - Erie Retinal Surgery & Erie Retina Research
  - Philadelphia, Pennsylvania, United States, 19107
    - Recruiting
    - Mid Atlantic Retina, Wills Eye Hospital
  - Philadelphia, Pennsylvania, United States, 19141
    - Recruiting
    - Vision Research Solutions - the Eye Institute
  - Sewickley, Pennsylvania, United States, 15143
    - Recruiting
    - Sewickley Eye Group
- South Carolina
  - Greenville, South Carolina, United States, 29605
    - Recruiting
    - Retina Consultants of Carolina
  - Ladson, South Carolina, United States, 29456
    - Recruiting
    - Charleston Neuroscience Institute LLC
  - Mt. Pleasant, South Carolina, United States, 29464
    - Recruiting
    - Charleston Neuroscience Institute, LLC
  - West Columbia, South Carolina, United States, 29169
    - Recruiting
    - Palmetto Retina Center
- South Dakota
  - Rapid City, South Dakota, United States, 57701
    - Recruiting
    - Black Hills Regional Eye Institute
- Tennessee
  - Nashville, Tennessee, United States, 37203
    - Recruiting
    - Tennessee Retina, PC
  - Nashville, Tennessee, United States, 37232
    - Recruiting
    - Vanderbilt Eye Institute
- Texas
  - Abilene, Texas, United States, 79606
    - Recruiting
    - Retina Research Institute of Texas
  - Austin, Texas, United States, 78705
    - Recruiting
    - Austin Research Center for Retina
  - Austin, Texas, United States, 78705
    - Recruiting
    - Austin Retina Associates
  - Austin, Texas, United States, 78750
    - Withdrawn
    - Austin Clinical Research LLC
  - Bellaire, Texas, United States, 77401
    - Recruiting
    - Retina Consultants Texas
  - Burleson, Texas, United States, 76028
    - Recruiting
    - Star Retina PLLC
  - Dallas, Texas, United States, 75390
    - Recruiting
    - University of Texas Southwestern Medical Center
  - Dallas, Texas, United States, 75231
    - Recruiting
    - Texas Retina Associates
  - Dallas, Texas, United States, 75231
    - Recruiting
    - Retina Foundation of the Southwest
  - Katy, Texas, United States, 77494
    - Recruiting
    - Retina Consultants of Texas
  - McAllen, Texas, United States, 78503
    - Recruiting
    - Valley Retina Institute, P.A.
  - Plano, Texas, United States, 75024
    - Completed
    - Red River Research Partners (Formerly AXIS Clinical)
  - Round Rock, Texas, United States, 78681
    - Recruiting
    - Austin Retina Associates
  - San Antonio, Texas, United States, 78240
    - Recruiting
    - Medical Center Ophthalmology Associates
  - San Antonio, Texas, United States, 78240
    - Recruiting
    - Retina Consultants of Texas
  - San Antonio, Texas, United States, 78240
    - Recruiting
    - Retina Associates of South Texas
  - San Antonio, Texas, United States, 78251
    - Recruiting
    - Retina Consultants of Texas Brown Retina Institute
  - Southlake, Texas, United States, 76092
    - Recruiting
    - Retina Center of Texas
  - The Woodlands, Texas, United States, 77384
    - Recruiting
    - Retina Consultants Texas
  - Tyler, Texas, United States, 75703
    - Recruiting
    - Tyler Retina Research Institute- Ophthalmology
- Utah
  - Salt Lake City, Utah, United States, 84107
    - Recruiting
    - Rocky Mountain Retina Consultants
  - Salt Lake City, Utah, United States, 84107
    - Recruiting
    - Retina Associates Of Utah Retina Specialist
  - West Jordan, Utah, United States, 84088
    - Recruiting
    - Salt Lake Retina- Ophthalmology
- Vermont
  - Burlington, Vermont, United States, 05401
    - Recruiting
    - University of Vermont
- Virginia
  - Bristol, Virginia, United States, 24201
    - Recruiting
    - Southeastern Retina Associates
  - Fairfax, Virginia, United States, 22031
    - Recruiting
    - Retina Group of Washington
  - Lynchburg, Virginia, United States, 24502
    - Recruiting
    - Piedmont Eye Center
  - Richmond, Virginia, United States, 23226
    - Recruiting
    - Virginia Eye Institute
  - Richmond, Virginia, United States, 23235
    - Completed
    - Retina Institute of Virginia
- Washington
  - Spokane, Washington, United States, 99204
    - Recruiting
    - Spokane Eye Clinical Research
- West Virginia
  - Morgantown, West Virginia, United States, 26506
    - Recruiting
    - West Virginia University Eye Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pozelimab + Cemdisiran treatment group Randomized 1:1:1	Drug: Pozelimab Subcutaneous (SC) injection Other Names: REGN3918 Drug: Cemdisiran SC injection Other Names: ALN-CC5
Experimental: Cemdisiran monotherapy treatment group Randomized 1:1:1	Drug: Cemdisiran SC injection Other Names: ALN-CC5
Placebo Comparator: Placebo treatment group Randomized 1:1:1	Drug: Placebo SC injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Growth rate (slope) of total GA lesion area (mm^2 /year) from baseline, measured by Fundus Autofluorescence (FAF) Time Frame: To week 52	To week 52

Secondary Outcome Measures

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regeneron Pharmaceuticals

Investigators

Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 30, 2024

Primary Completion (Estimated)

November 29, 2027

Study Completion (Estimated)

May 21, 2032

Study Registration Dates

First Submitted

August 2, 2024

First Submitted That Met QC Criteria

August 2, 2024

First Posted (Actual)

August 7, 2024

Study Record Updates

Last Update Posted (Actual)

May 27, 2026

Last Update Submitted That Met QC Criteria

May 25, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

GA secondary to AMD

Additional Relevant MeSH Terms

Other Study ID Numbers

R3918-AMD-2326
2023-509547-27-00 (Ctis: EU CT number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.

IPD Sharing Time Frame

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 Sharing Access Criteria

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 Sharing Supporting Information Type

STUDY_PROTOCOL
SAP
ICF
ANALYTIC_CODE
CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Outcome Measure	Time Frame
Loss of Best Corrected Visual Acuity (BCVA) ≥15 letters [Early Treatment Diabetic Retinopathy Study (ETDRS)] from baseline Time Frame: At week 52 and week 104	At week 52 and week 104
Change from baseline in Low-Contrast quantitative Visual Acuity (LC-qVA) Time Frame: At week 52 and week 104	At week 52 and week 104
Change from baseline in Low-Luminance Low-Contrast quantitative Visual Acuity (LL-LC-qVA) Time Frame: At week 52 and week 104	At week 52 and week 104
Change from baseline in quantitative Contrast Sensitivity Function (qCSF) Time Frame: At week 52 and week 104	At week 52 and week 104
Growth rate (slope) of total GA lesion area (mm^2 /year) from baseline measured by FAF Time Frame: To week 104	To week 104
Concentrations of total pozelimab in serum Time Frame: Through week 52 and through week 104	Through week 52 and through week 104
Concentrations of total cemdisiran in plasma Time Frame: Through week 52 and through week 104	Through week 52 and through week 104
Change from baseline in concentration of total Complement component 5 (C5) Time Frame: Through week 52 and through week 104	Through week 52 and through week 104
Incidence of Antidrug antibody (ADA) to pozelimab Time Frame: Through week 52 and through week 104	Through week 52 and through week 104
Magnitude of ADA to pozelimab Time Frame: Through week 52 and through week 104	Through week 52 and through week 104
Incidence of ADA to cemdisiran Time Frame: Through week 52 and through week 104	Through week 52 and through week 104
Magnitude of ADA to cemdisiran Time Frame: Through week 52 and through week 104	Through week 52 and through week 104
Incidence of Neutralizing Antibody (NAb) to pozelimab Time Frame: Through week 52 and through week 104	Through week 52 and through week 104
Occurrence of Treatment-Emergent Adverse Events (TEAEs) Time Frame: Through week 52, 104, 140 and week 296	Through week 52, 104, 140 and week 296
Severity of TEAEs Time Frame: Through week 52, 104, 140 and week 296	Through week 52, 104, 140 and week 296

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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

Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Contact

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Time Frame

Secondary Outcome Measures

Outcome Measure

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

IPD Sharing Time Frame

IPD Sharing Access Criteria

IPD Sharing Supporting Information Type

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

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