RECRUITING

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

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Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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)

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

Quick Facts

Study Start:2024-10-30
Study Completion:2032-05-21
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06541704

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Study eye with diagnosis of GA of the macula secondary to AMD as described in the protocol
  2. 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. 3. BCVA of 55 letters or better using ETDRS charts (20/80 Snellen equivalent) in the study eye as described in the protocol
  4. 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. 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
  1. 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. 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. 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. 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. 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. 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. 7. History or current use of systemic complement inhibitor therapy within 6 months prior to randomization as described in the protocol
  8. 8. History of solid organ or bone marrow transplantation
  9. 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. 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. 11. Not meeting meningococcal or pneumococcal vaccination requirements as described in the protocol
  12. 12. Carrier of Neisseria meningitidis based on culture collected during screening
  13. 13. Has a hemoglobin A1C ≥ 8.0% during screening as described in the protocol

Contacts and Locations

Study Contact

Clinical Trials Administrator
CONTACT
844-734-6643
clinicaltrials@regeneron.com

Principal Investigator

Clinical Trial Management
STUDY_DIRECTOR
Regeneron Pharmaceuticals

Study Locations (Sites)

Barnet Dulaney Perkins Eye Center
Phoenix, Arizona, 85016-4701
United States
Associated Retina Consultants
Phoenix, Arizona, 85020
United States
Retinal Research Institute
Phoenix, Arizona, 85053
United States
Retina Vitreous Associates Medical Group
Beverly Hills, California, 90211
United States
The Retina Partners
Encino, California, 91436
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
South Coast Retina Center
Long Beach, California, 90807
United States
American Institute of Research
Los Angeles, California, 90017
United States
Retinal Consultants Medical Group Inc Modesto
Modesto, California, 95356
United States
California Retina Consultants
Oxnard, California, 93036
United States
California Eye Specialists Medical Group Inc.
Pasadena, California, 91107
United States
Retina Consultants San Diego
Poway, California, 92064
United States
Vrmg Inc
Sacramento, California, 95825
United States
Retinal Consultants Medical Group (RCMG) - Greenback Lane Retina Center
Sacramento, California, 95841
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
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 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
Florida Retina Institute, Jacksonville Perimeter Park- Ophthalmology
Jacksonville, Florida, 32216
United States
Florida Retina Consultants
Lakeland, Florida, 33805
United States
Florida Retina Institute - Orlando
Orlando, Florida, 32806
United States
Retina Care Specialists
Palm Beach Gardens, Florida, 33410
United States
Retina Vitreous Associates of Florida Saint Petersburg
Saint Petersburg, Florida, 33711
United States
Retina Group of Florida, RAS-Sarasota Retina Center-Ophthalmology
Sarasota, Florida, 34232
United States
Southeast Retina Center
Augusta, Georgia, 30909
United States
Georgia Retina - Marietta
Marietta, Georgia, 30060
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
Retina Associates, LLC
Lenexa, Kansas, 66215
United States
Ross Davis Retina
Metairie, Louisiana, 70006
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
Mid Atlantic Retina Specialist
Hagerstown, Maryland, 217400
United States
Cumberland Valley Retina Consultants-Ophthalmology
Hagerstown, Maryland, 21740
United States
Opthalmic Consultants of Boston
Boston, Massachusetts, 02114
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
Saint Louis, Missouri, 63144
United States
Retina Vitreous Surgeons of Central New York, PC
Liverpool, New York, 13088
United States
Western Carolina Retinal Associates
Asheville, North Carolina, 28803
United States
Graystone Eye
Hickory, North Carolina, 28602
United States
Piedmont Retina Specialist
Winston-Salem, North Carolina, 27103
United States
Cincinnati Eye Institute
Cincinnati, Ohio, 45242
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
Portland, Oregon, 97221
United States
EyeHealth Northwest
Portland, Oregon, 97225
United States
Cascade Medical Research Institute LLC
Springfield, Oregon, 97477
United States
Erie Retinal Surgery & Erie Retina Research
Erie, Pennsylvania, 16507
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
Mount Pleasant, South Carolina, 29464
United States
Palmetto Retina Center
West Columbia, South Carolina, 29169
United States
Tennessee Retina, PC
Nashville, Tennessee, 37203
United States
Austin Research Center for Retina
Austin, Texas, 78705
United States
Austin Retina Associates
Austin, Texas, 78705
United States
Retina Consultants Texas
Bellaire, Texas, 77401
United States
Star Retina PLLC
Burleson, Texas, 76028
United States
Red River Research Partners (Formerly AXIS Clinical)
Dallas, Texas, 75024
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
Austin Retina Associates
Round Rock, Texas, 78681
United States
Retina Associates of South Texas
San Antonio, Texas, 782401375
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
Retina Associates Of Utah Retina Specialist
Salt Lake City, Utah, 84107
United States
Piedmont Eye Center
Lynchburg, Virginia, 24502
United States
Virginia Eye Institute
Richmond, Virginia, 23226
United States

Collaborators and Investigators

Sponsor: Regeneron Pharmaceuticals

  • Clinical Trial Management, STUDY_DIRECTOR, Regeneron Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-30
Study Completion Date2032-05-21

Study Record Updates

Study Start Date2024-10-30
Study Completion Date2032-05-21

Terms related to this study

Keywords Provided by Researchers

  • GA secondary to AMD

Additional Relevant MeSH Terms

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