AzTrials
AzTrials

Age-related Macular Degeneration (AMD)Phase 3SIENNANCT06541704

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

A Phase 3 study testing Pozelimab and Cemdisiran in people with Age-related Macular Degeneration (AMD) and Geographic Atrophy (GA), run by Regeneron Pharmaceuticals at 231 sites in 11 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 50 to 85 years
What is being tested?
Pozelimab and Cemdisiran
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
975 participants
Where
231 sitesin 11 countries
Study dates
30 Oct 2024to 9 Apr 2033
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 15Show fewer
  • 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

Trial locations and contacts

231 sites in 11 countries. Contact the study team or a site near you to ask about taking part.

Clinical Trials Administrator contact

844-734-6643

clinicaltrials@regeneron.com

231 sites in 11 countries

United States158 sites, 145 recruiting

  • Retina Research Institute of Texas

    Abilene, Texas, 79606

    Recruiting

  • Vision Research Center at Eye Associates of New Mexico

    Albuquerque, New Mexico, 87109

    Recruiting

  • University of New Mexico, HSC

    Albuquerque, New Mexico, 87131

    Completed

  • Western Carolina Retinal Associates

    Asheville, North Carolina, 28803

    Completed

  • Southeast Retina Center

    Augusta, Georgia, 30909

    Recruiting

  • University of Colorado

    Aurora, Colorado, 80045

    Recruiting

  • Austin Research Center for Retina

    Austin, Texas, 78705

    Recruiting

  • Austin Retina Associates

    Austin, Texas, 78705

    Recruiting

  • Austin Clinical Research LLC

    Austin, Texas, 78750

    Withdrawn

  • The Retina Care Center

    Baltimore, Maryland, 21209

    Recruiting

  • Retina Consultants Texas

    Bellaire, Texas, 77401

    Recruiting

  • Mid Atlantic Retina

    Bethlehem, Pennsylvania, 18017

    Recruiting

  • Retina Vitreous Associates Medical Group

    Beverly Hills, California, 90211

    Recruiting

  • Retina Specialists of Beverly Hills- Department of Ophthalmology

    Beverly Hills, California, 90212

    Recruiting

  • Advanced Retina Institute-Ophthalmology

    Bonita Springs, Florida, 34134

    Recruiting

  • Massachusetts Eye And Ear Infirmary

    Boston, Massachusetts, 02114

    Recruiting

  • Opthalmic Consultants of Boston

    Boston, Massachusetts, 02114

    Recruiting

  • Sight MD

    Brentwood, New York, 11717

    Recruiting

  • Southeastern Retina Associates

    Bristol, Virginia, 24201

    Recruiting

  • Star Retina PLLC

    Burleson, Texas, 76028

    Recruiting

  • University of Vermont

    Burlington, Vermont, 05401

    Recruiting

  • Midwest Eye Institute

    Carmel, Indiana, 46032

    Recruiting

  • NC Retina Associates

    Cary, North Carolina, 27511

    Recruiting

  • Barnet Dulaney Perkins Eye Center-Ophthamalogy

    Chandler, Arizona, 85224

    Recruiting

  • Mid Atlantic Retina - Cherry Hill

    Cherry Hill, New Jersey, 08034

    Recruiting

  • The Retina Group of Washington

    Chevy Chase, Maryland, 20815

    Recruiting

  • University of Illinois at Chicago

    Chicago, Illinois, 60612

    Recruiting

  • Retinal Vitreal Consultants

    Chicago, Illinois, 60616

    Recruiting

  • The University of Chicago

    Chicago, Illinois, 60637

    Recruiting

  • Cincinnati Eye Institute

    Cincinnati, Ohio, 45242

    Recruiting

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

    Recruiting

  • Retina Consultants of Southern Colorado

    Colorado Springs, Colorado, 80909

    Recruiting

  • The Ohio State University

    Columbus, Ohio, 43212

    Recruiting

  • Advanced Research

    Coral Springs, Florida, 33067

    Recruiting

  • Retina Foundation of the Southwest

    Dallas, Texas, 75231

    Recruiting

  • Texas Retina Associates

    Dallas, Texas, 75231

    Recruiting

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

    Recruiting

  • Retina Specialists of Colorado - Denver

    Denver, Colorado, 80222

    Recruiting

  • Midwest Retina, Inc

    Dublin, Ohio, 43016

    Recruiting

  • Southwest Retina Research Center

    Durango, Colorado, 81303

    Recruiting

  • Retina Vitreous Center - Edmond

    Edmond, Oklahoma, 73013

    Recruiting

  • The Retina Partners

    Encino, California, 91436

    Completed

  • Erie Retinal Surgery & Erie Retina Research

    Erie, Pennsylvania, 16507

    Recruiting

  • Verum Research LLC

    Eugene, Oregon, 97401

    Recruiting

  • Retina Group of Washington

    Fairfax, Virginia, 22031

    Recruiting

  • Retina Group of Florida

    Fort Lauderdale, Florida, 33308

    Recruiting

  • National Ophthalmic Research Institute

    Fort Myers, Florida, 33912

    Withdrawn

  • Eye Medical Center of Fresno

    Fresno, California, 93720

    Recruiting

  • Retina Consultants of Orange County

    Fullerton, California, 92835

    Completed

  • Retina Associates of Michigan

    Grand Blanc, Michigan, 48439

    Recruiting

  • Retina Consultants of Carolina

    Greenville, South Carolina, 29605

    Recruiting

  • Cumberland Valley Retina Consultants-Ophthalmology

    Hagerstown, Maryland, 21740

    Recruiting

  • Mid Atlantic Retina Specialist

    Hagerstown, Maryland, 21740

    Recruiting

  • Graystone Eye

    Hickory, North Carolina, 28602

    Recruiting

  • ClearVista Clinical Research, Retina Center Tampa Bay

    Hudson, Florida, 34667

    Recruiting

  • Salehi Retina Institute dba Retina Associates of Southern California

    Huntington Beach, California, 92647

    Recruiting

  • University of California Irvine

    Irvine, California, 92617

    Recruiting

  • Florida Retina Institute, Jacksonville Perimeter Park- Ophthalmology

    Jacksonville, Florida, 32216

    Recruiting

  • Retina Consultants of Texas

    Katy, Texas, 77494

    Recruiting

  • University of California San Diego, Jacobs Retina Center

    La Jolla, California, 92093

    Recruiting

  • Charleston Neuroscience Institute LLC

    Ladson, South Carolina, 29456

    Recruiting

  • Florida Retina Consultants

    Lakeland, Florida, 33805

    Recruiting

  • Colorado Retina - Lakewood

    Lakewood, Colorado, 80228

    Recruiting

  • University Retina and Macula Associates PC - Lemont

    Lemont, Illinois, 60439

    Recruiting

  • Retina Associates, LLC

    Lenexa, Kansas, 66215

    Recruiting

  • Retina Vitreous Surgeons of Central New York, PC

    Liverpool, New York, 13088

    Recruiting

  • South Coast Retina Center

    Long Beach, California, 90807

    Recruiting

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

    Longmont, Colorado, 80503

    Recruiting

  • American Institute of Research

    Los Angeles, California, 90017

    Completed

  • Kaiser Permanente Los Angeles Medical Center

    Los Angeles, California, 90027

    Recruiting

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

    Los Angeles, California, 90095

    Recruiting

  • University of Louisville

    Louisville, Kentucky, 40202

    Recruiting

  • Piedmont Eye Center

    Lynchburg, Virginia, 24502

    Recruiting

  • Mississippi Retina Associates

    Madison, Mississippi, 39110

    Recruiting

  • Retina Consultants - Manchester

    Manchester, Connecticut, 06042

    Recruiting

  • Georgia Retina - Marietta

    Marietta, Georgia, 30060

    Recruiting

  • Valley Retina Institute, P.A.

    McAllen, Texas, 78503

    Recruiting

  • Retina Associate New Orleans

    Metairie, Louisiana, 70001

    Recruiting

  • Ross Davis Retina

    Metairie, Louisiana, 70001

    Recruiting

  • Retinal Consultants Medical Group Inc Modesto

    Modesto, California, 95356

    Recruiting

  • West Virginia University Eye Institute

    Morgantown, West Virginia, 26506

    Withdrawn

  • Northern California Retina Vitreous Associates Medical Group, Inc.

    Mountain View, California, 94040

    Recruiting

  • Charleston Neuroscience Institute, LLC

    Mt. Pleasant, South Carolina, 29464

    Recruiting

  • Bascom Palmer Eye Institute

    Naples, Florida, 34103

    Recruiting

  • Nashua Eye Associates

    Nashua, New Hampshire, 03063

    Recruiting

  • Tennessee Retina, PC

    Nashville, Tennessee, 37203

    Recruiting

  • Vanderbilt Eye Institute

    Nashville, Tennessee, 37232

    Recruiting

  • Ochsner Health

    New Orleans, Louisiana, 70121

    Recruiting

  • MaculaCare, PLLC

    New York, New York, 10021

    Withdrawn

  • New York Ear & Eye- East 85th

    New York, New York, 10028

    Recruiting

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

    New York, New York, 10065

    Recruiting

  • Retina Associates of New York, Upper East Side

    New York, New York, 10075

    Recruiting

  • Illinois Retina Associates

    Oak Park, Illinois, 60304

    Recruiting

  • Florida Retina Institute - Orlando

    Orlando, Florida, 32806

    Recruiting

  • California Retina Consultants

    Oxnard, California, 93036

    Recruiting

  • Retina Care Specialists

    Palm Beach Gardens, Florida, 33410

    Recruiting

  • Desert Retina Consultants

    Palm Desert, California, 92211

    Withdrawn

  • California Eye Specialists Medical Group Inc.

    Pasadena, California, 91107

    Recruiting

  • Mid Atlantic Retina, Wills Eye Hospital

    Philadelphia, Pennsylvania, 19107

    Recruiting

  • Vision Research Solutions - the Eye Institute

    Philadelphia, Pennsylvania, 19141

    Recruiting

  • Barnet Dulaney Perkins Eye Center

    Phoenix, Arizona, 85016

    Recruiting

  • Associated Retina Consultants

    Phoenix, Arizona, 85020

    Recruiting

  • Retinal Research Institute

    Phoenix, Arizona, 85053

    Recruiting

  • Eye Associates of Pinellas

    Pinellas Park, Florida, 33782

    Recruiting

  • Red River Research Partners (Formerly AXIS Clinical)

    Plano, Texas, 75024

    Completed

  • Retina Northwest, The Highlands Building

    Portland, Oregon, 97221

    Recruiting

  • EyeHealth Northwest

    Portland, Oregon, 97225

    Recruiting

  • OHSU-Casey Eye Institute, Marquam Hill-Ophthalmology

    Portland, Oregon, 97239

    Recruiting

  • Seeta Eye center

    Poughkeepsie, New York, 12603

    Recruiting

  • Retina Consultants San Diego

    Poway, California, 92064

    Recruiting

  • Black Hills Regional Eye Institute

    Rapid City, South Dakota, 57701

    Recruiting

  • California Eye Specialists Medical Group, Inc.

    Redlands, California, 92373

    Recruiting

  • Virginia Eye Institute

    Richmond, Virginia, 23226

    Recruiting

  • Retina Institute of Virginia

    Richmond, Virginia, 23235

    Completed

  • Austin Retina Associates

    Round Rock, Texas, 78681

    Recruiting

  • Optic Eye Care

    Rowland Heights, California, 91748

    Recruiting

  • UC Davis Health Eye Center

    Sacramento, California, 95817

    Recruiting

  • Vrmg Inc

    Sacramento, California, 95825

    Recruiting

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

    Sacramento, California, 95841

    Recruiting

  • Retina Associates Of Utah Retina Specialist

    Salt Lake City, Utah, 84107

    Recruiting

  • Rocky Mountain Retina Consultants

    Salt Lake City, Utah, 84107

    Recruiting

  • Medical Center Ophthalmology Associates

    San Antonio, Texas, 78240

    Recruiting

  • Retina Associates of South Texas

    San Antonio, Texas, 78240

    Recruiting

  • Retina Consultants of Texas

    San Antonio, Texas, 78240

    Recruiting

  • Retina Consultants of Texas Brown Retina Institute

    San Antonio, Texas, 78251

    Recruiting

  • West Coast Retina Medical Group, Inc.

    San Francisco, California, 94109

    Recruiting

  • Orange County Retina Medical Group

    Santa Ana, California, 92705

    Recruiting

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

    Sarasota, Florida, 34232

    Recruiting

  • Retina Macula Institute of Arizona

    Scottsdale, Arizona, 85255

    Recruiting

  • Sewickley Eye Group

    Sewickley, Pennsylvania, 15143

    Recruiting

  • Ophthalmology, LTD - Sioux Falls

    Sioux Falls, South Dakota, 57108

    Recruiting

  • Deep Blue Retina Clinical Research PLLC

    Southaven, Mississippi, 38671

    Recruiting

  • Retina Center of Texas

    Southlake, Texas, 76092

    Recruiting

  • Spokane Eye Clinical Research

    Spokane, Washington, 99204

    Recruiting

  • Retina Partners of Northwest Arkansas, PLLC

    Springdale, Arkansas, 72764

    Recruiting

  • Springfield Clinic Main Campus East

    Springfield, Illinois, 62703

    Recruiting

  • New England Retina Consultants, PC

    Springfield, Massachusetts, 01107

    Recruiting

  • Cascade Medical Research Institute LLC

    Springfield, Oregon, 97477

    Recruiting

  • Retina Research Institute, LLC

    St Louis, Missouri, 63144

    Recruiting

  • Retina Vitreous Associates of Florida Saint Petersburg

    St. Petersburg, Florida, 33711

    Recruiting

  • University of South Florida Ophthalmology

    Tampa, Florida, 33612

    Recruiting

  • New Jersey Retina

    Teaneck, New Jersey, 07666

    Recruiting

  • Retina Consultants Texas

    The Woodlands, Texas, 77384

    Recruiting

  • New Jersey Retina

    Toms River, New Jersey, 08755

    Recruiting

  • Macula Retina Vitreous Research Institute

    Torrance, California, 90503

    Recruiting

  • Retina Associates of Tuscan

    Tucson, Arizona, 85712

    Recruiting

  • Tulsa Retina Consultants

    Tulsa, Oklahoma, 74114

    Recruiting

  • Tyler Retina Research Institute- Ophthalmology

    Tyler, Texas, 75703

    Recruiting

  • North Carolina Retina Associates

    Wake Forest, North Carolina, 27587

    Recruiting

  • Massachusetts Eye Research and Surgery Institution (MERSI)

    Waltham, Massachusetts, 02451

    Recruiting

  • Retina Group of New England

    Waterford, Connecticut, 06385

    Terminated

  • Palmetto Retina Center

    West Columbia, South Carolina, 29169

    Recruiting

  • Salt Lake Retina- Ophthalmology

    West Jordan, Utah, 84088

    Recruiting

  • Eye Assoc. of NE LA dba Haik Humble Eye Ctr

    West Monroe, Louisiana, 71291

    Recruiting

  • Eye Associates of Northeast Louisiana dba Haik Humble Eye Center

    West Monroe, Louisiana, 71291

    Recruiting

  • Piedmont Retina Specialist

    Winston-Salem, North Carolina, 27103

    Recruiting

  • Center for Retina and Macular Disease

    Winter Haven, Florida, 33880

    Recruiting

  • Vitreo-Retinal Associates PC

    Worcester, Massachusetts, 01605

    Recruiting

Other trials in United States

Germany16 sites, 16 recruiting

  • Charite - Universitaetsmedizin Berlin

    Berlin, Brandenburg, 12203

    Recruiting

  • Universitatsklinikum Bonn

    Bonn, North Rhine-Westphalia, 53127

    Recruiting

  • Klinik fur Augenheilkunde Universitatsklinikum Dusseldorf

    Düsseldorf, North Rhine-Westphalia, 40225

    Recruiting

  • Augenzentrum Frankfurt

    Frankfurt am Main, Hesse, 60549

    Recruiting

  • University Medicine Goetting

    Göttingen, Lower Saxony, 37075

    Recruiting

  • University Hospital Hamburg Eppendorf

    Hamburg, 20246

    Recruiting

  • Saarland University Medical Center

    Homburg, Saarland, 66421

    Recruiting

  • Klinikum Ludwigshafen Augenklinik

    Ludwigshafen am Rhein, Rhineland-Palatinate, 67063

    Recruiting

  • University Medical Center of the Johannes Gutenberg-University Mainz

    Mainz, 55131

    Recruiting

  • Universitaetsklinikum Marburg, Klinik fuer Augenheilkunde

    Marburg, Hesse, 35043

    Recruiting

  • Universitaetsklinikum Muenster

    Münster, North Rhine-Westphalia, 48149

    Recruiting

  • St. Franziskus-Hospital

    Münster, 48145

    Recruiting

  • Dietrich Bonhoeffer Klinikum

    Neubrandenburg, Mecklenburg-Vorpommern, 17036

    Recruiting

  • Knappschaftsklinikum Saar GmbH- Eye Clnic Sulzbach

    Sulzbach, Saarland, 66280

    Recruiting

  • University of Ulm

    Ulm, Baden-Wurttemberg, 89081

    Recruiting

  • Universitaetsklinikum Wuerzburg AöR

    Würzburg, 97080

    Recruiting

Other trials in Germany

France13 sites, 13 recruiting

  • Centre Hospitalier Intercommunal de Creteil

    Créteil, 94010

    Recruiting

  • Centre Hospitalier Universitaire Francois Mitterrand

    Dijon, 21000

    Recruiting

  • Intercard

    Lille, 59800

    Recruiting

  • Hopital De La Croix-Rousse

    Lyon, 69317

    Recruiting

  • Pole Vision Val d'Ouest

    Lyon, 69317

    Recruiting

  • Hopital Saint Joseph

    Marseille, Bouches Du Rhone, 13008

    Recruiting

  • Centre Monticelli Paradis

    Marseille, 13008

    Recruiting

  • Centre Hospitalier Universitaire de Nantes

    Nantes, 44000

    Recruiting

  • Centre Hospitalier Universitaire de Nice

    Nice, Alpes Maritimes, 6002

    Recruiting

  • Hopital Lariboisiere

    Paris, 75010

    Recruiting

  • Centre Hospitalier Universitaire De Poitiers

    Poitiers, New Aquitaine, 86000

    Recruiting

  • Clinique Mathilde

    Rouen, 76100

    Recruiting

  • Toulouse University Hospital

    Toulouse, Occitanie, 31059

    Recruiting

Other trials in France

Spain11 sites, 11 recruiting

  • Centro de Oftalmologia Barraquer

    Barcelona, 08021

    Recruiting

  • Instituto de Microcirugia Ocular

    Barcelona, 08035

    Recruiting

  • Institut Catala De Retina S.L.

    Barcelona, 8022

    Recruiting

  • Oftalvist Clinic. IMED Hospital

    Burjassot, Valencia, 46100

    Recruiting

  • Hospital Arruzafa

    Córdoba, Andalusia, 14012

    Recruiting

  • Bellvitge University Hospital

    L'Hospitalet de Llobregat, Barcelona, 8907

    Recruiting

  • Hospital Universitario Virgen Macarena

    Seville, 41009

    Recruiting

  • Hospital de Terrassa (Consorci Sanitari de Terrassa)

    Terrassa, Barcelona, 08227

    Recruiting

  • Fundacion Aiken De La Comunitat Valenciana

    Valencia, 46004

    Recruiting

  • Hospital Clinico Universitario Lozano Blesa. IIS Aragon

    Zaragoza, 50009

    Recruiting

  • Miguel Servet University Hospital

    Zaragoza, 50009

    Recruiting

Other trials in Spain

Italy9 sites, 9 recruiting

  • Azienda Ospedaliero Universitaria delle Marche

    Ancona, 60126

    Recruiting

  • Azienda Ospedaliero Universitaria Careggi

    Florence, Tuscany, 50134

    Recruiting

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

    Milan, Lombardy, 20122

    Recruiting

  • IRCCS MultiMedica

    Milan, Lombardy, 20123

    Recruiting

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

    Milan, Milano, 20132

    Recruiting

  • Universita degli Studi di Milano

    Milan, 20157

    Recruiting

  • University Hospital PTV

    Rome, Lazio, 00133

    Recruiting

  • Fondazione Policlinico Gemelli

    Rome, Lazio, 00168

    Recruiting

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

    Rome, 00184

    Recruiting

Other trials in Italy

United Kingdom6 sites, 6 recruiting

  • University Hospitals Bristol NHS Foundation Trust

    Bristol, BS1 2LX

    Recruiting

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

    Liverpool, Merseyside, L7 8XP

    Recruiting

  • Moorfields Eye Hospital NHS Foundation Trust, Moorfields Eye Hospital

    London, EC1V 2PD

    Recruiting

  • Imperial College Healthcare NHS Trust

    London, NW1 5QH

    Recruiting

  • The Newcastle Upon Tyne Hospitals NHS Foundation Trust

    Newcastle upon Tyne, NE1 4LP

    Recruiting

  • York and Scarborough Teaching Hospitals NHS Foundation Trust

    York, North Yorkshire, YP31 8HE

    Recruiting

Other trials in United Kingdom

Australia5 sites, 5 recruiting

  • Adelaide Eye and Retina Centre-Opthamalogy

    Adelaide, South Australia, 5000

    Recruiting

  • Eye Clinic Albury Wodonga

    Albury, New South Wales, 2640

    Recruiting

  • Centre for Eye Research Australia (CERA)

    East Melbourne, Victoria, 3002

    Recruiting

  • Retina and Eye Consultants

    Hurstville, New South Wales, 2220

    Recruiting

  • Strathfield Retina Clinic

    Strathfield, New South Wales, 2135

    Recruiting

Other trials in Australia

Hungary5 sites, 5 recruiting

  • Semmelweis University

    Budapest, 1085

    Recruiting

  • Budapest Retina Associates

    Budapest, 1133

    Recruiting

  • University Of Debrecen, Hungary

    Debrecen, Hajdú-Bihar, 4032

    Recruiting

  • Ganglion Medical Center

    Pécs, Baranya, 7621

    Recruiting

  • University Of Szeged

    Szeged, Csongrad-Csanad, 6720

    Recruiting

Other trials in Hungary

Austria3 sites, 3 recruiting

  • Medical University Graz

    Graz, Styria, 8036

    Recruiting

  • Medical University of Vienna

    Vienna, 1090

    Recruiting

  • VIROS - Vienna Institute for Research in Ocular Surgery

    Vienna, 1140

    Recruiting

Other trials in Austria

Poland3 sites, 3 recruiting

  • Oftalmika Sp. z o.o.

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-631

    Recruiting

  • Centrum Diagnostyki I Mikrochirurgii Oka Lens Sp zoo

    Olsztyn, Warmian-Masurian Voivodeship, 10-424

    Recruiting

  • Caminomed

    Tarnowskie Góry, Silesian Voivodeship, 42-600

    Recruiting

Other trials in Poland

Canada2 sites, 2 recruiting

  • Retina Centre of Ottawa

    Ottawa, Ontario, K2B 7E9

    Recruiting

  • Centre Hospitalier Universitaire de Quebec Universite Laval

    Québec, G1S 4L8

    Recruiting

Other trials in Canada

About this study

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

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.

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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)
Being tested
Pozelimab, Cemdisiran, Placebo
Keywords
GA secondary to AMD
Medical subject headings
Macular Degeneration, Geographic Atrophy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PozelimabDrug

    Also called REGN3918

    Subcutaneous (SC) injection

  • CemdisiranDrug

    Also called ALN-CC5

    SC injection

  • PlaceboDrug

    SC injection

Study groups in NCT06541704
Study groupRoleWhat they receive
Pozelimab + Cemdisiran treatment groupExperimentalRandomized 1:1:1
Receives: Drug: Pozelimab; Drug: Cemdisiran
Cemdisiran monotherapy treatment groupExperimentalRandomized 1:1:1
Receives: Drug: Cemdisiran
Placebo treatment groupPlacebo comparatorRandomized 1:1:1
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Growth rate (slope) of total GA lesion area (mm^2 /year) from baseline, measured by Fundus Autofluorescence (FAF)

    Measured: To week 52

Secondary outcomes (15)

  1. Loss of Best Corrected Visual Acuity (BCVA) ≥15 letters [Early Treatment Diabetic Retinopathy Study (ETDRS)] from baseline

    Measured: At week 52 and week 104

  2. Change from baseline in Low-Contrast quantitative Visual Acuity (LC-qVA)

    Measured: At week 52 and week 104

  3. Change from baseline in Low-Luminance Low-Contrast quantitative Visual Acuity (LL-LC-qVA)

    Measured: At week 52 and week 104

  4. Change from baseline in quantitative Contrast Sensitivity Function (qCSF)

    Measured: At week 52 and week 104

  5. Growth rate (slope) of total GA lesion area (mm^2 /year) from baseline measured by FAF

    Measured: To week 104

  6. Concentrations of total pozelimab in serum

    Measured: Through week 52 and through week 104

  7. Concentrations of total cemdisiran in plasma

    Measured: Through week 52 and through week 104

  8. Change from baseline in concentration of total Complement component 5 (C5)

    Measured: Through week 52 and through week 104

  9. Incidence of Antidrug antibody (ADA) to pozelimab

    Measured: Through week 52 and through week 104

  10. Magnitude of ADA to pozelimab

    Measured: Through week 52 and through week 104

  11. Incidence of ADA to cemdisiran

    Measured: Through week 52 and through week 104

  12. Magnitude of ADA to cemdisiran

    Measured: Through week 52 and through week 104

  13. Incidence of Neutralizing Antibody (NAb) to pozelimab

    Measured: Through week 52 and through week 104

  14. Occurrence of Treatment-Emergent Adverse Events (TEAEs)

    Measured: Through week 52, 104, 140 and week 296

  15. Severity of TEAEs

    Measured: Through week 52, 104, 140 and week 296

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Aug 2024
  2. Study start30 Oct 2024
  3. Primary completion31 Jul 2028 (estimated)
  4. Study completion9 Apr 2033 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
975 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06541704
Sponsor's protocol ID
R3918-AMD-2326
Other IDs
2023-509547-27-00, 2023
Acronym
SIENNA
Status last verified
Oct 2026
First submitted
2 Aug 2024
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pozelimab and Cemdisiran in people with Age-related Macular Degeneration (AMD) and Geographic Atrophy (GA), run by Regeneron Pharmaceuticals at 231 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 231 sites in United States, Germany, France, Spain, Italy and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Clinical Trials Administrator (844-734-6643, clinicaltrials@regeneron.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Growth rate (slope) of total GA lesion area (mm^2 /year) from baseline, measured by Fundus Autofluorescence (FAF) (time frame: To week 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06541704.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.

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