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NCT06541704PHASE3Recruiting

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

Regeneron Pharmaceuticals

Start Date

10/30/2024

Completion Date

4/9/2033

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)

Eligibility Criteria

Age Range: 50 years to 85 years

Key Inclusion Criteria: 1. Study eye with diagnosis of GA of the macula secondary to AMD as described in the protocol 2. Total GA area in the study eye measuring between ≥2.5 mm\^2 and ≤17.5 mm\^2 as described in the protocol 3. BCVA of 55 letters or better using ETDRS charts (20/80 Snellen equivalent) in the study eye as described in the protocol 4. Sufficiently clear ocular media, adequate pupillary dilation and fixation to permit quality fundus imaging in the study eye as described in the protocol 5. 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: 1. GA in either eye due to causes other than AMD, such as Stargardt disease, cone rod dystrophy or toxic maculopathies like hydroxychloroquine maculopathy 2. History or current evidence of Macular Neovascularization (MNV) and/or exudation or Peripapillary Choroidal Neovascularization (PPCNV) in either eye as described in the protocol 3. 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 4. 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 5. 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 6. 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 7. History or current use of systemic complement inhibitor therapy within 6 months prior to randomization as described in the protocol 8. History of solid organ or bone marrow transplantation 9. 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 10. 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 11. Not meeting meningococcal or pneumococcal vaccination requirements as described in the protocol 12. Carrier of Neisseria meningitidis based on culture collected during screening 13. Has a hemoglobin A1C ≥ 8.0% during screening as described in the protocol NOTE: Other protocol-defined Inclusion/ Exclusion Criteria apply

Interventions

DRUG

Pozelimab

DRUG

Cemdisiran

DRUG

Placebo

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Conditions

Age-related Macular Degeneration (AMD)Geographic Atrophy (GA)

Locations

Barnet Dulaney Perkins Eye Center-Ophthamalogy

Chandler, Arizona 85224

United States

Barnet Dulaney Perkins Eye Center

Phoenix, Arizona 85016

United States

Associated Retina Consultants

Phoenix, Arizona 85020

United States

Retinal Research Institute

Phoenix, Arizona 85053

United States

Retina Macula Institute of Arizona

Scottsdale, Arizona 85255

United States

Retina Associates of Tuscan

Tucson, Arizona 85712

United States

Retina Partners of Northwest Arkansas, PLLC

Springdale, Arkansas 72764

United States

Retina Vitreous Associates Medical Group

Beverly Hills, California 90211

United States

Retina Specialists of Beverly Hills- Department of Ophthalmology

Beverly Hills, California 90212

United States

The Retina Partners

Encino, California 91436

United States

Eye Medical Center of Fresno

Fresno, California 93720

United States

Retina Consultants of Orange County

Fullerton, California 92835

United States

Salehi Retina Institute dba Retina Associates of Southern California

Huntington Beach, California 92647

United States

University of California Irvine

Irvine, California 92617

United States

University of California San Diego, Jacobs Retina Center

La Jolla, California 92093

United States

South Coast Retina Center

Long Beach, California 90807

United States

American Institute of Research

Los Angeles, California 90017

United States

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California 90027

United States

Jules Stein Eye Institute in David Geffen School of Medicine at UCLA

Los Angeles, California 90095

United States

Retinal Consultants Medical Group Inc Modesto

Modesto, California 95356

United States

Northern California Retina Vitreous Associates Medical Group, Inc.

Mountain View, California 94040

United States

California Retina Consultants

Oxnard, California 93036

United States

Desert Retina Consultants

Palm Desert, California 92211

United States

California Eye Specialists Medical Group Inc.

Pasadena, California 91107

United States

Retina Consultants San Diego

Poway, California 92064

United States

California Eye Specialists Medical Group, Inc.

Redlands, California 92373

United States

Optic Eye Care

Rowland Heights, California 91748

United States

UC Davis Health Eye Center

Sacramento, California 95817

United States

Vrmg Inc

Sacramento, California 95825

United States

Retinal Consultants Medical Group (RCMG) - Greenback Lane Retina Center

Sacramento, California 95841

United States

West Coast Retina Medical Group, Inc.

San Francisco, California 94109

United States

Orange County Retina Medical Group

Santa Ana, California 92705

United States

Macula Retina Vitreous Research Institute

Torrance, California 90503

United States

University of Colorado

Aurora, Colorado 80045

United States

Retina Consultants of Southern Colorado

Colorado Springs, Colorado 80909

United States

Retina Specialists of Colorado - Denver

Denver, Colorado 80222

United States

Southwest Retina Research Center

Durango, Colorado 81303

United States

Colorado Retina - Lakewood

Lakewood, Colorado 80228

United States

Eye care Center of Northern Colorado doing business as Advanced Vision Research Institute

Longmont, Colorado 80503

United States

Retina Group of New England

Waterford, Connecticut 06385

United States

Advanced Retina Institute-Ophthalmology

Bonita Springs, Florida 34134

United States

Advanced Research

Coral Springs, Florida 33067

United States

Retina Group of Florida

Fort Lauderdale, Florida 33308

United States

National Ophthalmic Research Institute

Fort Myers, Florida 33912

United States

ClearVista Clinical Research, Retina Center Tampa Bay

Hudson, Florida 34667

United States

Florida Retina Institute, Jacksonville Perimeter Park- Ophthalmology

Jacksonville, Florida 32216

United States

Florida Retina Consultants

Lakeland, Florida 33805

United States

Bascom Palmer Eye Institute

Naples, Florida 34103

United States

Florida Retina Institute - Orlando

Orlando, Florida 32806

United States

Retina Care Specialists

Palm Beach Gardens, Florida 33410

United States

Eye Associates of Pinellas

Pinellas Park, Florida 33782

United States

Retina Group of Florida, RAS-Sarasota Retina Center-Ophthalmology

Sarasota, Florida 34232

United States

Retina Vitreous Associates of Florida Saint Petersburg

St. Petersburg, Florida 33711

United States

University of South Florida Ophthalmology

Tampa, Florida 33612

United States

Center for Retina and Macular Disease

Winter Haven, Florida 33880

United States

Southeast Retina Center

Augusta, Georgia 30909

United States

Georgia Retina - Marietta

Marietta, Georgia 30060

United States

University of Illinois at Chicago

Chicago, Illinois 60612

United States

Retinal Vitreal Consultants

Chicago, Illinois 60616

United States

The University of Chicago

Chicago, Illinois 60637

United States

University Retina and Macula Associates PC - Lemont

Lemont, Illinois 60439

United States

Illinois Retina Associates

Oak Park, Illinois 60304

United States

Springfield Clinic Main Campus East

Springfield, Illinois 62703

United States

Retina Associates, LLC

Lenexa, Kansas 66215

United States

University of Louisville

Louisville, Kentucky 40202

United States

Retina Associate New Orleans

Metairie, Louisiana 70001

United States

Ross Davis Retina

Metairie, Louisiana 70006

United States

Ochsner Health

New Orleans, Louisiana 70121

United States

Eye Assoc. of NE LA dba Haik Humble Eye Ctr

West Monroe, Louisiana 71291

United States

Eye Associates of Northeast Louisiana dba Haik Humble Eye Center

West Monroe, Louisiana 71291

United States

The Retina Care Center

Baltimore, Maryland 21209

United States

The Retina Group of Washington

Chevy Chase, Maryland 20815

United States

Cumberland Valley Retina Consultants-Ophthalmology

Hagerstown, Maryland 21740

United States

Mid Atlantic Retina Specialist

Hagerstown, Maryland 21740

United States

Massachusetts Eye And Ear Infirmary

Boston, Massachusetts 02114

United States

Opthalmic Consultants of Boston

Boston, Massachusetts 02114

United States

New England Retina Consultants, PC

Springfield, Massachusetts 01107

United States

Vitreo-Retinal Associates PC

Worcester, Massachusetts 01605

United States

Retina Associates of Michigan

Grand Blanc, Michigan 48439

United States

Mississippi Retina Associates

Madison, Mississippi 39110

United States

Deep Blue Retina Clinical Research PLLC

Southaven, Mississippi 38671

United States

Retina Research Institute, LLC

St Louis, Missouri 63144

United States

Mid Atlantic Retina - Cherry Hill

Cherry Hill, New Jersey 08034

United States

New Jersey Retina

Teaneck, New Jersey 07666

United States

New Jersey Retina

Toms River, New Jersey 08755

United States

Vision Research Center at Eye Associates of New Mexico

Albuquerque, New Mexico 87109

United States

University of New Mexico, HSC

Albuquerque, New Mexico 87131

United States

Sight MD

Brentwood, New York 11717

United States

Retina Vitreous Surgeons of Central New York, PC

Liverpool, New York 13088

United States

MaculaCare, PLLC

New York, New York 10021

United States

New York Ear & Eye- East 85th

New York, New York 10028

United States

Northwell Health- Manhattan, Ear, Eye and Throat Hospital- Ophthalmology

New York, New York 10065

United States

Retina Associates of New York, Upper East Side

New York, New York 10075

United States

Seeta Eye center

Poughkeepsie, New York 12603

United States

Western Carolina Retinal Associates

Asheville, North Carolina 28803

United States

NC Retina Associates

Cary, North Carolina 27511

United States

Graystone Eye

Hickory, North Carolina 28602

United States

North Carolina Retina Associates

Wake Forest, North Carolina 27587

United States

Piedmont Retina Specialist

Winston-Salem, North Carolina 27103

United States

Cincinnati Eye Institute

Cincinnati, Ohio 45242

United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio 44106

United States

The Ohio State University

Columbus, Ohio 43212

United States

Midwest Retina, Inc

Dublin, Ohio 43016

United States

Retina Vitreous Center - Edmond

Edmond, Oklahoma 73013

United States

Tulsa Retina Consultants

Tulsa, Oklahoma 74114

United States

Verum Research LLC

Eugene, Oregon 97401

United States

Retina Northwest, The Highlands Building

Portland, Oregon 97221

United States

EyeHealth Northwest

Portland, Oregon 97225

United States

OHSU-Casey Eye Institute, Marquam Hill-Ophthalmology

Portland, Oregon 97239

United States

Cascade Medical Research Institute LLC

Springfield, Oregon 97477

United States

Mid Atlantic Retina

Bethlehem, Pennsylvania 18017

United States

Erie Retinal Surgery & Erie Retina Research

Erie, Pennsylvania 16507

United States

Mid Atlantic Retina, Wills Eye Hospital

Philadelphia, Pennsylvania 19107

United States

Vision Research Solutions - the Eye Institute

Philadelphia, Pennsylvania 19141

United States

Sewickley Eye Group

Sewickley, Pennsylvania 15143

United States

Retina Consultants of Carolina

Greenville, South Carolina 29605

United States

Charleston Neuroscience Institute LLC

Ladson, South Carolina 29456

United States

Charleston Neuroscience Institute, LLC

Mt. Pleasant, South Carolina 29464

United States

Palmetto Retina Center

West Columbia, South Carolina 29169

United States

Black Hills Regional Eye Institute

Rapid City, South Dakota 57701

United States

Tennessee Retina, PC

Nashville, Tennessee 37203

United States

Vanderbilt Eye Institute

Nashville, Tennessee 37232

United States

Retina Research Institute of Texas

Abilene, Texas 79606

United States

Austin Research Center for Retina

Austin, Texas 78705

United States

Austin Retina Associates

Austin, Texas 78705

United States

Austin Clinical Research LLC

Austin, Texas 78750

United States

Retina Consultants Texas

Bellaire, Texas 77401

United States

Star Retina PLLC

Burleson, Texas 76028

United States

Retina Foundation of the Southwest

Dallas, Texas 75231

United States

Texas Retina Associates

Dallas, Texas 75231

United States

University of Texas Southwestern Medical Center

Dallas, Texas 75390

United States

Retina Consultants of Texas

Katy, Texas 77494

United States

Valley Retina Institute, P.A.

McAllen, Texas 78503

United States

Red River Research Partners (Formerly AXIS Clinical)

Plano, Texas 75024

United States

Austin Retina Associates

Round Rock, Texas 78681

United States

Medical Center Ophthalmology Associates

San Antonio, Texas 78240

United States

Retina Associates of South Texas

San Antonio, Texas 78240

United States

Retina Consultants of Texas

San Antonio, Texas 78240

United States

Retina Consultants of Texas Brown Retina Institute

San Antonio, Texas 78251

United States

Retina Center of Texas

Southlake, Texas 76092

United States

Retina Consultants Texas

The Woodlands, Texas 77384

United States

Tyler Retina Research Institute- Ophthalmology

Tyler, Texas 75703

United States

Retina Associates Of Utah Retina Specialist

Salt Lake City, Utah 84107

United States

Rocky Mountain Retina Consultants

Salt Lake City, Utah 84107

United States

Salt Lake Retina- Ophthalmology

West Jordan, Utah 84088

United States

University of Vermont

Burlington, Vermont 05401

United States

Southeastern Retina Associates

Bristol, Virginia 24201

United States

Retina Group of Washington

Fairfax, Virginia 22031

United States

Piedmont Eye Center

Lynchburg, Virginia 24502

United States

Virginia Eye Institute

Richmond, Virginia 23226

United States

Retina Institute of Virginia

Richmond, Virginia 23235

United States

Spokane Eye Clinical Research

Spokane, Washington 99204

United States

West Virginia University Eye Institute

Morgantown, West Virginia 26506

United States

Eye Clinic Albury Wodonga

Albury, New South Wales 2640

Australia

Retina and Eye Consultants

Hurstville, New South Wales 2220

Australia

Strathfield Retina Clinic

Strathfield, New South Wales 2135

Australia

Adelaide Eye and Retina Centre-Opthamalogy

Adelaide, South Australia 5000

Australia

Centre for Eye Research Australia (CERA)

East Melbourne, Victoria 3002

Australia

Medical University Graz

Graz, Styria 8036

Austria

Medical University of Vienna

Vienna, 1090

Austria

VIROS - Vienna Institute for Research in Ocular Surgery

Vienna, 1140

Austria

Retina Centre of Ottawa

Ottawa, Ontario K2B 7E9

Canada

Centre Hospitalier Universitaire de Quebec Universite Laval

Québec, G1S 4L8

Canada

Centre Hospitalier Universitaire de Nice

Nice, Alpes Maritimes 6002

France

Hopital Saint Joseph

Marseille, Bouches Du Rhone 13008

France

Centre Hospitalier Universitaire De Poitiers

Poitiers, New Aquitaine 86000

France

Toulouse University Hospital

Toulouse, Occitanie 31059

France

Centre Hospitalier Intercommunal de Creteil

Créteil, 94010

France

Centre Hospitalier Universitaire Francois Mitterrand

Dijon, 21000

France

Intercard

Lille, 59800

France

Hopital De La Croix-Rousse

Lyon, 69317

France

Pole Vision Val d'Ouest

Lyon, 69317

France

Centre Monticelli Paradis

Marseille, 13008

France

Centre Hospitalier Universitaire de Nantes

Nantes, 44000

France

Hopital Lariboisiere

Paris, 75010

France

University of Ulm

Ulm, Baden-Wurttemberg 89081

Germany

Charite - Universitaetsmedizin Berlin

Berlin, Brandenburg 12203

Germany

Augenzentrum Frankfurt

Frankfurt am Main, Hesse 60549

Germany

Universitaetsklinikum Marburg, Klinik fuer Augenheilkunde

Marburg, Hesse 35043

Germany

Dietrich Bonhoeffer Klinikum

Neubrandenburg, Mecklenburg-Vorpommern 17036

Germany

Universitatsklinikum Bonn

Bonn, North Rhine-Westphalia 53127

Germany

Klinik fur Augenheilkunde Universitatsklinikum Dusseldorf

Düsseldorf, North Rhine-Westphalia 40225

Germany

Universitaetsklinikum Muenster

Münster, North Rhine-Westphalia 48149

Germany

Klinikum Ludwigshafen Augenklinik

Ludwigshafen am Rhein, Rhineland-Palatinate 67063

Germany

Saarland University Medical Center

Homburg, Saarland 66421

Germany

Knappschaftsklinikum Saar GmbH- Eye Clnic Sulzbach

Sulzbach, Saarland 66280

Germany

University Hospital Hamburg Eppendorf

Hamburg, 20246

Germany

University Medical Center of the Johannes Gutenberg-University Mainz

Mainz, 55131

Germany

St. Franziskus-Hospital

Münster, 48145

Germany

Ganglion Medical Center

Pécs, Baranya 7621

Hungary

University Of Szeged

Szeged, Csongrad-Csanad 6720

Hungary

University Of Debrecen, Hungary

Debrecen, Hajdú-Bihar 4032

Hungary

Semmelweis University

Budapest, 1085

Hungary

Budapest Retina Associates

Budapest, 1133

Hungary

University Hospital PTV

Rome, Lazio 00133

Italy

Fondazione Policlinico Gemelli

Rome, Lazio 00168

Italy

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, Lombardy 20122

Italy

IRCCS MultiMedica

Milan, Lombardy 20123

Italy

Ospedale San Raffaele (HSR) - Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS)

Milan, Milano 20132

Italy

Azienda Ospedaliero Universitaria Careggi

Florence, Tuscany 50134

Italy

Azienda Ospedaliero Universitaria delle Marche

Ancona, 60126

Italy

Universita degli Studi di Milano

Milan, 20157

Italy

Fondazione G.B.Bietti Per Lo Studio E La Ricerca In Oftalmologia

Rome, 00184

Italy

Oftalmika Sp. z o.o.

Bydgoszcz, Kuyavian-Pomeranian Voivodeship 85-631

Poland

Caminomed

Tarnowskie Góry, Silesian Voivodeship 42-600

Poland

Centrum Diagnostyki I Mikrochirurgii Oka Lens Sp zoo

Olsztyn, Warmian-Masurian Voivodeship 10-424

Poland

Hospital Arruzafa

Córdoba, Andalusia 14012

Spain

Bellvitge University Hospital

L'Hospitalet de Llobregat, Barcelona 8907

Spain

Hospital de Terrassa (Consorci Sanitari de Terrassa)

Terrassa, Barcelona 08227

Spain

Oftalvist Clinic. IMED Hospital

Burjassot, Valencia 46100

Spain

Centro de Oftalmologia Barraquer

Barcelona, 08021

Spain

Instituto de Microcirugia Ocular

Barcelona, 08035

Spain

Institut Catala De Retina S.L.

Barcelona, 8022

Spain

Hospital Universitario Virgen Macarena

Seville, 41009

Spain

Fundacion Aiken De La Comunitat Valenciana

Valencia, 46004

Spain

Hospital Clinico Universitario Lozano Blesa. IIS Aragon

Zaragoza, 50009

Spain

Miguel Servet University Hospital

Zaragoza, 50009

Spain

Liverpool University Hospitals NHS Foundation Trust-Royal Liverpool University Hospital, St Paul's Eye Unit-Ophthalmology

Liverpool, Merseyside L7 8XP

United Kingdom

York and Scarborough Teaching Hospitals NHS Foundation Trust

York, North Yorkshire YP31 8HE

United Kingdom

University Hospitals Bristol NHS Foundation Trust

Bristol, BS1 2LX

United Kingdom

Moorfields Eye Hospital NHS Foundation Trust, Moorfields Eye Hospital

London, EC1V 2PD

United Kingdom

Imperial College Healthcare NHS Trust

London, NW1 5QH

United Kingdom

The Newcastle Upon Tyne Hospitals NHS Foundation Trust

Newcastle upon Tyne, NE1 4LP

United Kingdom