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

Last updated: April 21, 2025
Sponsor: Regeneron Pharmaceuticals
Overall Status: Active - Recruiting

Phase

3

Condition

Geographic Atrophy

Macular Degeneration

Treatment

Cemdisiran

Placebo

Pozelimab

Clinical Study ID

NCT06541704
R3918-AMD-2326
2023-509547-27-00
  • Ages > 50
  • All Genders

Study 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

Inclusion

Key Inclusion Criteria:

  1. Study eye with diagnosis of GA of the macula secondary to AMD not involving thefoveal center point as described in the protocol

  2. Total GA area in the study eye measuring between ≥2.5 mm2 and ≤17.5 mm2 as describedin the protocol

  3. BCVA of 35 letters or better using ETDRS charts (20/200 Snellen equivalent) in thestudy eye as described in the protocol

  4. Sufficiently clear ocular media, adequate pupillary dilation and fixation to permitquality 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 andpneumococcal vaccination required per protocol

Exclusion

Key Exclusion Criteria:

  1. GA in either eye due to causes other than AMD such as Stargardt disease, cone roddystrophy or toxic maculopathies like hydroxychloroquine maculopathy

  2. History or current evidence of macular neovascularization and/or exudation in eithereye as described in the protocol

  3. Prior or current Intravitreal (IVT) treatment of any kind for any indication instudy eye or fellow eye, except approved or investigational IVT complement inhibitortherapy as long as last dose was ≥6 months prior to randomization

  4. Prior intraocular surgery except cataract extraction or minimally invasive glaucomasurgery in study eye as long as date of these procedures was ≥3 months prior torandomization

  5. Comorbid progressive ocular condition (eg, diabetic retinopathy, macular edema,uncontrolled glaucoma, full thickness macular hole) in study eye that could affectcentral vision and confound study

  6. Any ophthalmologic condition that reduces the clarity of the media and that, in theopinion of the investigator interferes with ophthalmologic examination of the studyeye (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 monthsprior 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 oralprednisone or equivalent) within the previous 30 days prior to the first screeningvisit as described in the protocol

  10. Current or prior use of systemic immunosuppressive therapy other thancorticosteroids or the likelihood of treatment with any such agent during the studyinclusive of the screening period

  11. Not meeting meningococcal or pneumococcal vaccination requirements as described inthe 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

Study Design

Total Participants: 750
Treatment Group(s): 3
Primary Treatment: Cemdisiran
Phase: 3
Study Start date:
October 30, 2024
Estimated Completion Date:
May 21, 2032

Connect with a study center

  • Retina Centre of Ottawa-Department of Ophthalmology

    Ottawa, Ontario K2B7E9
    Canada

    Active - Recruiting

  • Associated Retina Consultants

    Phoenix, Arizona 85020
    United States

    Active - Recruiting

  • Retina Vitreous Associates Medical Group

    Beverly Hills, California 90211
    United States

    Active - Recruiting

  • Retina Consultants of Orange County

    Fullerton, California 92835
    United States

    Active - Recruiting

  • Salehi Retina Institute dba Retina Associates of Southern California

    Huntington Beach, California 92647
    United States

    Active - Recruiting

  • South Coast Retina Center

    Long Beach, California 90807
    United States

    Active - Recruiting

  • American Institute of Research

    Los Angeles, California 90017
    United States

    Active - Recruiting

  • Retinal Consultants Medical Group Inc Modesto

    Modesto, California 95356
    United States

    Active - Recruiting

  • California Retina Consultants

    Oxnard, California 93036
    United States

    Active - Recruiting

  • Retina Consultants San Diego

    Poway, California 92064
    United States

    Active - Recruiting

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

    Sacramento, California 95841
    United States

    Active - Recruiting

  • VRMG, Inc

    Sacramento, California 95825
    United States

    Active - Recruiting

  • Vrmg Inc

    Sacramento, California 95825
    United States

    Active - Recruiting

  • Macula Retina Vitreous Research Institute

    Torrance, California 90503
    United States

    Active - Recruiting

  • Retina Consultants of Southern Colorado

    Colorado Springs, Colorado 80909
    United States

    Active - Recruiting

  • Southwest Retina Research Center

    Durango, Colorado 81303
    United States

    Active - Recruiting

  • Colorado Retina - Lakewood

    Lakewood, Colorado 80228
    United States

    Active - Recruiting

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

    Longmont, Colorado 80503
    United States

    Active - Recruiting

  • Retina Group of New England

    Waterford, Connecticut 06385
    United States

    Active - Recruiting

  • Advanced Research

    Coral Springs, Florida 33067
    United States

    Active - Recruiting

  • Retina Group of Florida

    Fort Lauderdale, Florida 33308
    United States

    Active - Recruiting

  • National Ophthalmic Research Institute

    Fort Myers, Florida 33912
    United States

    Active - Recruiting

  • Florida Retina Institute - Jacksonville

    Jacksonville, Florida 32216
    United States

    Active - Recruiting

  • Florida Retina Institute, Jacksonville Perimeter Park- Ophthalmology

    Jacksonville, Florida 32216
    United States

    Active - Recruiting

  • Florida Retina Institute - Orlando

    Orlando, Florida 32806
    United States

    Active - Recruiting

  • Retina Vitreous Associates of Florida Saint Petersburg

    Saint Petersburg, Florida 33711
    United States

    Active - Recruiting

  • Southeast Retina Center

    Augusta, Georgia 30909
    United States

    Active - Recruiting

  • Georgia Retina - Marietta

    Marietta, Georgia 30060
    United States

    Active - Recruiting

  • The University of Chicago

    Chicago, Illinois 60637
    United States

    Active - Recruiting

  • University Retina and Macula Associates PC - Lemont

    Lemont, Illinois 60439
    United States

    Active - Recruiting

  • Illinois Retina Associates

    Oak Park, Illinois 60304
    United States

    Active - Recruiting

  • Ross Davis Retina

    Metairie, Louisiana 70006
    United States

    Active - Recruiting

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

    West Monroe, Louisiana 71291
    United States

    Active - Recruiting

  • Eye Associates of Northeast Louisiana dba Haik Humble Eye Center

    West Monroe, Louisiana 71291
    United States

    Active - Recruiting

  • Cumberland Valley Retina Consultants

    Hagerstown, Maryland 21740
    United States

    Active - Recruiting

  • Cumberland Valley Retina Consultants-Ophthalmology

    Hagerstown, Maryland 21740
    United States

    Active - Recruiting

  • Mid Atlantic Retina Specialist

    Hagerstown, Maryland 217400
    United States

    Active - Recruiting

  • Opthalmic Consultants of Boston

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Mississippi Retina Associates

    Madison, Mississippi 39110
    United States

    Active - Recruiting

  • Retina Research Institute, LLC

    Saint Louis, Missouri 63144
    United States

    Active - Recruiting

  • Retina Vitreous Surgeons of Central New York, PC

    Liverpool, New York 13088
    United States

    Active - Recruiting

  • Western Carolina Retinal Associates

    Asheville, North Carolina 28803
    United States

    Active - Recruiting

  • Graystone Eye

    Hickory, North Carolina 28602
    United States

    Active - Recruiting

  • Piedmont Retina Specialist

    Winston-Salem, North Carolina 27103
    United States

    Active - Recruiting

  • Cincinnati Eye Institute

    Cincinnati, Ohio 45242
    United States

    Active - Recruiting

  • Retina Vitreous Center - Edmond

    Edmond, Oklahoma 73013
    United States

    Active - Recruiting

  • Tulsa Retina Consultants

    Tulsa, Oklahoma 74114
    United States

    Active - Recruiting

  • Verum Research LLC

    Eugene, Oregon 97401
    United States

    Active - Recruiting

  • EyeHealth Northwest

    Portland, Oregon 97225
    United States

    Active - Recruiting

  • Cascade Medical Research Institute LLC

    Springfield, Oregon 97477
    United States

    Active - Recruiting

  • Erie Retinal Surgery & Erie Retina Research

    Erie, Pennsylvania 16507
    United States

    Active - Recruiting

  • Sewickley Eye Group

    Sewickley, Pennsylvania 15143
    United States

    Active - Recruiting

  • Charleston Neuroscience Institute LLC

    Ladson, South Carolina 29456
    United States

    Active - Recruiting

  • Charleston Neuroscience Institute, LLC

    Ladson, South Carolina 29456
    United States

    Active - Recruiting

  • Charleston Neuroscience Institute, LLC

    Mount Pleasant, South Carolina 29464
    United States

    Active - Recruiting

  • Palmetto Retina Center

    West Columbia, South Carolina 29169
    United States

    Active - Recruiting

  • Tennessee Retina, PC

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Austin Research Center for Retina

    Austin, Texas 78705
    United States

    Active - Recruiting

  • Austin Retina Associates

    Austin, Texas 78705
    United States

    Active - Recruiting

  • Retina Consultants Texas

    Bellaire, Texas 77401
    United States

    Active - Recruiting

  • Star Retina PLLC

    Burleson, Texas 76028
    United States

    Active - Recruiting

  • Retina Consultants of Texas

    Katy, Texas 77494
    United States

    Active - Recruiting

  • Valley Retina Institute, P.A.

    McAllen, Texas 78503
    United States

    Active - Recruiting

  • Austin Retina Associates

    Round Rock, Texas 78681
    United States

    Active - Recruiting

  • Retina Consultants of Texas

    San Antonio, Texas 78240
    United States

    Active - Recruiting

  • Retina Consultants of Texas Brown Retina Institute

    San Antonio, Texas 78251
    United States

    Active - Recruiting

  • Retina Center of Texas

    Southlake, Texas 76092
    United States

    Active - Recruiting

  • Retina Consultants Texas

    The Woodlands, Texas 77384
    United States

    Active - Recruiting

  • Retina Associates Of Utah Retina Specialist

    Salt Lake City, Utah 84107
    United States

    Active - Recruiting

  • Piedmont Eye Center

    Lynchburg, Virginia 24502
    United States

    Active - Recruiting

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