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

Status: Recruiting
Location: See all (110) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 85
Healthy Volunteers: f
View:

• 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

Locations
United States
Arizona
Associated Retina Consultants
RECRUITING
Phoenix
Barnet Dulaney Perkins Eye Center
RECRUITING
Phoenix
Retinal Research Institute
RECRUITING
Phoenix
Retina Associates of Tuscan
RECRUITING
Tucson
California
Retina Vitreous Associates Medical Group
RECRUITING
Beverly Hills
The Retina Partners
RECRUITING
Encino
Eye Medical Center of Fresno
RECRUITING
Fresno
Retina Consultants of Orange County
RECRUITING
Fullerton
Salehi Retina Institute dba Retina Associates of Southern California
RECRUITING
Huntington Beach
University of California San Diego, Jacobs Retina Center
RECRUITING
La Jolla
South Coast Retina Center
RECRUITING
Long Beach
American Institute of Research
RECRUITING
Los Angeles
Retinal Consultants Medical Group Inc Modesto
RECRUITING
Modesto
California Retina Consultants
RECRUITING
Oxnard
California Eye Specialists Medical Group Inc.
RECRUITING
Pasadena
Retina Consultants San Diego
RECRUITING
Poway
California Eye Specialists Medical Group, Inc.
RECRUITING
Redlands
Retinal Consultants Medical Group (RCMG) - Greenback Lane Retina Center
RECRUITING
Sacramento
Vrmg Inc
RECRUITING
Sacramento
West Coast Retina Medical Group, Inc.
RECRUITING
San Francisco
Orange County Retina Medical Group
RECRUITING
Santa Ana
Macula Retina Vitreous Research Institute
RECRUITING
Torrance
Colorado
University of Colorado
RECRUITING
Aurora
Retina Consultants of Southern Colorado
RECRUITING
Colorado Springs
Southwest Retina Research Center
RECRUITING
Durango
Colorado Retina - Lakewood
RECRUITING
Lakewood
Eye care Center of Northern Colorado doing business as Advanced Vision Research Institute
RECRUITING
Longmont
Connecticut
Retina Group of New England
RECRUITING
Waterford
Florida
Advanced Research
RECRUITING
Coral Springs
Retina Group of Florida
RECRUITING
Fort Lauderdale
National Ophthalmic Research Institute
RECRUITING
Fort Myers
Florida Retina Institute, Jacksonville Perimeter Park- Ophthalmology
RECRUITING
Jacksonville
Florida Retina Consultants
RECRUITING
Lakeland
Florida Retina Institute - Orlando
RECRUITING
Orlando
Retina Care Specialists
RECRUITING
Palm Beach Gardens
Retina Group of Florida, RAS-Sarasota Retina Center-Ophthalmology
RECRUITING
Sarasota
Retina Vitreous Associates of Florida Saint Petersburg
RECRUITING
St. Petersburg
Georgia
Southeast Retina Center
RECRUITING
Augusta
Georgia Retina - Marietta
RECRUITING
Marietta
Illinois
Retinal Vitreal Consultants
RECRUITING
Chicago
The University of Chicago
RECRUITING
Chicago
University Retina and Macula Associates PC - Lemont
RECRUITING
Lemont
Illinois Retina Associates
RECRUITING
Oak Park
Springfield Clinic Main Campus East
RECRUITING
Springfield
Kansas
Retina Associates, LLC
RECRUITING
Lenexa
Louisiana
Retina Associates New Orleans
RECRUITING
Metairie
Ross Davis Retina
RECRUITING
Metairie
Eye Assoc. of NE LA dba Haik Humble Eye Ctr
RECRUITING
West Monroe
Eye Associates of Northeast Louisiana dba Haik Humble Eye Center
RECRUITING
West Monroe
Massachusetts
Opthalmic Consultants of Boston
RECRUITING
Boston
New England Retina Consultants, PC
RECRUITING
Springfield
Maryland
Cumberland Valley Retina Consultants-Ophthalmology
RECRUITING
Hagerstown
Mid Atlantic Retina Specialist
RECRUITING
Hagerstown
Missouri
Retina Research Institute, LLC
RECRUITING
St Louis
Mississippi
Mississippi Retina Associates
RECRUITING
Madison
Deep Blue Retina Clinical Research PLLC
RECRUITING
Southaven
North Carolina
Western Carolina Retinal Associates
RECRUITING
Asheville
Graystone Eye
RECRUITING
Hickory
Piedmont Retina Specialist
RECRUITING
Winston-salem
New York
Sight MD
RECRUITING
Brentwood
Retina Vitreous Surgeons of Central New York, PC
RECRUITING
Liverpool
Ohio
Cincinnati Eye Institute
RECRUITING
Cincinnati
The Ohio State University
RECRUITING
Columbus
Midwest Retina, Inc
RECRUITING
Dublin
Oklahoma
Retina Vitreous Center - Edmond
RECRUITING
Edmond
Tulsa Retina Consultants
RECRUITING
Tulsa
Oregon
Verum Research LLC
RECRUITING
Eugene
EyeHealth Northwest
RECRUITING
Portland
Retina Northwest, The Highlands Building
RECRUITING
Portland
Cascade Medical Research Institute LLC
RECRUITING
Springfield
Pennsylvania
Mid Atlantic Retina
RECRUITING
Bethlehem
Erie Retinal Surgery & Erie Retina Research
RECRUITING
Erie
Sewickley Eye Group
RECRUITING
Sewickley
South Carolina
Retina Consultants of Carolina
RECRUITING
Greenville
Charleston Neuroscience Institute LLC
RECRUITING
Ladson
Charleston Neuroscience Institute, LLC
RECRUITING
Mt. Pleasant
Palmetto Retina Center
RECRUITING
West Columbia
Tennessee
Tennessee Retina, PC
RECRUITING
Nashville
Texas
Austin Research Center for Retina
RECRUITING
Austin
Austin Retina Associates
RECRUITING
Austin
Retina Consultants Texas
RECRUITING
Bellaire
Star Retina PLLC
RECRUITING
Burleson
Red River Research Partners (Formerly AXIS Clinical)
RECRUITING
Dallas
Retina Foundation of the Southwest
RECRUITING
Dallas
Texas Retina Associates
RECRUITING
Dallas
University of Texas Southwestern Medical Center
RECRUITING
Dallas
Retina Consultants of Texas
RECRUITING
Katy
Valley Retina Institute, P.A.
RECRUITING
Mcallen
Austin Retina Associates
RECRUITING
Round Rock
Medical Center Ophthalmology Associates
RECRUITING
San Antonio
Retina Associates of South Texas
RECRUITING
San Antonio
Retina Consultants of Texas
RECRUITING
San Antonio
Retina Consultants of Texas Brown Retina Institute
RECRUITING
San Antonio
Retina Center of Texas
RECRUITING
Southlake
Retina Consultants Texas
RECRUITING
The Woodlands
Utah
Retina Associates Of Utah Retina Specialist
RECRUITING
Salt Lake City
Virginia
Piedmont Eye Center
RECRUITING
Lynchburg
Virginia Eye Institute
RECRUITING
Richmond
Other Locations
Austria
Medical University Graz
RECRUITING
Graz
VIROS - Vienna Institute for Research in Ocular Surgery
RECRUITING
Vienna
Canada
Retina Centre of Ottawa - Department of Ophthalmology
RECRUITING
Ottawa
Germany
Saarland University Medical Center
RECRUITING
Homburg
Universitaetsklinikum Marburg, Klinik fuer Augenheilkunde
RECRUITING
Marburg
St. Franziskus-Hospital
RECRUITING
Münster
Universitaetsklinikum Muenster
RECRUITING
Münster
Knappschaftsklinikum Saar GmbH- Eye Clnic Sulzbach
RECRUITING
Sulzbach
Hungary
Budapest Retina Associates
RECRUITING
Budapest
Spain
Oftalvist Clinic. IMED Hospital
RECRUITING
Burjassot
Hospital Arruzafa
RECRUITING
Córdoba
Hospital Universitario Virgen Macarena Unidad Coronaria 1 planta
RECRUITING
Seville
Contact Information
Primary
Clinical Trials Administrator
clinicaltrials@regeneron.com
844-734-6643
Time Frame
Start Date: 2024-10-30
Estimated Completion Date: 2032-05-21
Participants
Target number of participants: 975
Treatments
Experimental: Pozelimab + Cemdisiran treatment group
Randomized 1:1:1
Experimental: Cemdisiran monotherapy treatment group
Randomized 1:1:1
Placebo_comparator: Placebo treatment group
Randomized 1:1:1
Sponsors
Leads: Regeneron Pharmaceuticals

This content was sourced from clinicaltrials.gov

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