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RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: Regeneron Pharmaceuticals • ClinicalTrials.gov ID: NCT06541704

Registry updated: 2026-10-13
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Description

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)

Interventions

  • Pozelimab (Drug)
    Subcutaneous (SC) injection
  • Cemdisiran (Drug)
    SC injection
  • Placebo (Drug)
    SC injection

Eligibility criteria

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

Conditions

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

Locations

  • 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 Consultants - Manchester — Manchester, Connecticut, 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
  • Midwest Eye Institute — Carmel, Indiana, United States
  • Retina Associates, LLC — Lenexa, Kansas, United States
  • University of Louisville — Louisville, Kentucky, United States
  • Retina Associate 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
  • Massachusetts Eye Research and Surgery Institution (MERSI) — Waltham, Massachusetts, United States
  • Vitreo-Retinal Associates PC — Worcester, 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
  • Nashua Eye Associates — Nashua, New Hampshire, 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
  • Ophthalmology, LTD - Sioux Falls — Sioux Falls, 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
  • Eye Clinic Albury Wodonga — Albury, New South Wales, Australia
  • Retina and Eye Consultants — Hurstville, New South Wales, Australia
  • Strathfield Retina Clinic — Strathfield, New South Wales, Australia
  • Adelaide Eye and Retina Centre-Opthamalogy — Adelaide, South Australia, Australia
  • Centre for Eye Research Australia (CERA) — East Melbourne, Victoria, Australia
  • 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 — 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, New Aquitaine, France
  • Toulouse University Hospital — Toulouse, Occitanie, France
  • Centre Hospitalier Intercommunal de Creteil — Créteil, France
  • Centre Hospitalier Universitaire Francois Mitterrand — Dijon, France
  • Intercard — Lille, 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
  • Clinique Mathilde — Rouen, 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
  • University Medicine Goetting — Göttingen, Lower Saxony, 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
  • Universitaetsklinikum Wuerzburg AöR — Würzburg, 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
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record