A Study Investigating Subcutaneously Administered Pozelimab in Combination With Cemdisiran or Cemdisiran Alone in Adult Participants With Geographic Atrophy
NCT ID: NCT06541704
Last Updated: 2025-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
975 participants
INTERVENTIONAL
2024-10-30
2032-05-21
Brief Summary
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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)
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Pozelimab + Cemdisiran treatment group
Randomized 1:1:1
Pozelimab
Subcutaneous (SC) injection
Cemdisiran
SC injection
Cemdisiran monotherapy treatment group
Randomized 1:1:1
Cemdisiran
SC injection
Placebo treatment group
Randomized 1:1:1
Placebo
SC injection
Interventions
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Pozelimab
Subcutaneous (SC) injection
Cemdisiran
SC injection
Placebo
SC injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
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
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
50 Years
85 Years
ALL
No
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trial Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
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Barnet Dulaney Perkins Eye Center
Phoenix, Arizona, United States
Associated Retina Consultants
Phoenix, Arizona, United States
Retinal Research Institute
Phoenix, Arizona, United States
Retina Associates of Tuscan
Tucson, Arizona, United States
Retina Vitreous Associates Medical Group
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 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
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
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
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
Southwest Retina Research Center
Durango, Colorado, United States
Colorado Retina - Lakewood
Lakewood, Colorado, United States
Eye care Center of Northern Colorado doing business as Advanced Vision Research Institute
Longmont, Colorado, United States
Retina Group of New England
Waterford, Connecticut, United States
Advanced Research
Coral Springs, Florida, United States
Retina Group of Florida
Fort Lauderdale, Florida, United States
National Ophthalmic Research Institute
Fort Myers, Florida, United States
Florida Retina Institute, Jacksonville Perimeter Park- Ophthalmology
Jacksonville, Florida, United States
Florida Retina Consultants
Lakeland, Florida, United States
Florida Retina Institute - Orlando
Orlando, Florida, United States
Retina Care Specialists
Palm Beach Gardens, 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
Southeast Retina Center
Augusta, Georgia, United States
Georgia Retina - Marietta
Marietta, Georgia, United States
Retinal Vitreal Consultants
Chicago, Illinois, United States
The University of Chicago
Chicago, Illinois, United States
University Retina and Macula Associates PC - Lemont
Lemont, Illinois, United States
Illinois Retina Associates
Oak Park, Illinois, United States
Springfield Clinic Main Campus East
Springfield, Illinois, United States
Retina Associates, LLC
Lenexa, Kansas, United States
Retina Associates New Orleans
Metairie, Louisiana, United States
Ross Davis Retina
Metairie, 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
Mid Atlantic Retina Specialist
Hagerstown, Maryland, United States
Cumberland Valley Retina Consultants-Ophthalmology
Hagerstown, Maryland, United States
Opthalmic Consultants of Boston
Boston, Massachusetts, United States
New England Retina Consultants, PC
Springfield, Massachusetts, 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
New Jersey Retina
Toms River, New Jersey, United States
Sight MD
Brentwood, New York, United States
Retina Vitreous Surgeons of Central New York, PC
Liverpool, New York, United States
Western Carolina Retinal Associates
Asheville, North Carolina, United States
Graystone Eye
Hickory, North Carolina, United States
Piedmont Retina Specialist
Winston-Salem, North Carolina, United States
Cincinnati Eye Institute
Cincinnati, 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
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
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
Tennessee Retina, PC
Nashville, Tennessee, United States
Austin Research Center for Retina
Austin, Texas, United States
Austin Retina Associates
Austin, Texas, United States
Retina Consultants Texas
Bellaire, Texas, United States
Star Retina PLLC
Burleson, Texas, United States
Red River Research Partners (Formerly AXIS Clinical)
Dallas, 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
Austin Retina Associates
Round Rock, Texas, United States
Retina Associates of South Texas
San Antonio, Texas, United States
Medical Center Ophthalmology Associates
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
Retina Associates Of Utah Retina Specialist
Salt Lake City, Utah, United States
Piedmont Eye Center
Lynchburg, Virginia, United States
Virginia Eye Institute
Richmond, Virginia, United States
Retina Institute of Virginia
Richmond, Virginia, United States
Medical University Graz
Graz, Styria, Austria
VIROS - Vienna Institute for Research in Ocular Surgery
Vienna, , Austria
Retina Centre of Ottawa - Department of Ophthalmology
Ottawa, Ontario, Canada
Centre Hospitalier Intercommunal de Creteil
Créteil, , France
Charite - Universitaetsmedizin Berlin
Berlin, Brandenburg, Germany
Universitaetsklinikum Marburg, Klinik fuer Augenheilkunde
Marburg, Hesse, Germany
Dietrich Bonhoeffer Klinikum
Neubrandenburg, Mecklenburg-Vorpommern, Germany
Universitaetsklinikum Muenster
Münster, North Rhine-Westphalia, Germany
Saarland University Medical Center
Homburg, Saarland, Germany
Knappschaftsklinikum Saar GmbH- Eye Clnic Sulzbach
Sulzbach, Saarland, Germany
St. Franziskus-Hospital
Münster, , Germany
Budapest Retina Associates
Budapest, , Hungary
Oftalmika Sp. z o.o.
Bydgoszcz, Kuyavian-Pomeranian 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
Hospital Universitario Virgen Macarena Unidad Coronaria 1 planta
Seville, , Spain
York and Scarborough Teaching Hospitals NHS Foundation Trust
York, North Yorkshire, United Kingdom
University Hospitals Bristol NHS Foundation Trust
Bristol, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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2023-509547-27-00
Identifier Type: CTIS
Identifier Source: secondary_id
R3918-AMD-2326
Identifier Type: -
Identifier Source: org_study_id