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

Part of paid clinical trials in Chandler, Arizona.

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT06541704
Phase
PHASE3
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
50 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Pozelimab — DRUG
    Subcutaneous (SC) injection
  • Cemdisiran — DRUG
    SC injection
  • Placebo — DRUG
    SC injection

Study Details

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)

Key Dates

Start date
Oct 30, 2024
Status verified
Mar 2026
Primary completion
Nov 29, 2027
Completion
May 21, 2032

Study Design

Enrollment
975 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Growth rate (slope) of total GA lesion area (mm^2 /year) from baseline, measured by Fundus Autofluorescence (FAF) [ Time Frame: To week 52 ]

Central Contacts

Locations (152)

FacilityCityStateZIPSite coordinators
Barnet Dulaney Perkins Eye Center-OphthamalogyChandlerArizona85224-
Associated Retina ConsultantsPhoenixArizona85020-
Barnet Dulaney Perkins Eye CenterPhoenixArizona85016-
Retinal Research InstitutePhoenixArizona85053-
Retina Macula Institute of ArizonaScottsdaleArizona85255-
Retina Associates of TuscanTucsonArizona85712-
Retina Partners of Northwest Arkansas, PLLCSpringdaleArkansas72764-
Retina Specialists of Beverly Hills- Department of OphthalmologyBeverly HillsCalifornia90212-
Retina Vitreous Associates Medical GroupBeverly HillsCalifornia90211-
The Retina PartnersEncinoCalifornia91436-
Eye Medical Center of FresnoFresnoCalifornia93720-
Retina Consultants of Orange CountyFullertonCalifornia92835-
Salehi Retina Institute dba Retina Associates of Southern CaliforniaHuntington BeachCalifornia92647-
University of California IrvineIrvineCalifornia92617-
University of California San Diego, Jacobs Retina CenterLa JollaCalifornia92093-
South Coast Retina CenterLong BeachCalifornia90807-
American Institute of ResearchLos AngelesCalifornia90017-
Jules Stein Eye Institute in David Geffen School of Medicine at UclaLos AngelesCalifornia90095-
Kaiser Permanente Los Angeles Medical CenterLos AngelesCalifornia90027-
Retinal Consultants Medical Group Inc ModestoModestoCalifornia95356-
Northern California Retina Vitreous Associates Medical Group, Inc.Mountain ViewCalifornia94040-
California Retina ConsultantsOxnardCalifornia93036-
Desert Retina ConsultantsPalm DesertCalifornia92211-
California Eye Specialists Medical Group Inc.PasadenaCalifornia91107-
Retina Consultants San DiegoPowayCalifornia92064-
California Eye Specialists Medical Group, Inc.RedlandsCalifornia92373-
Optic Eye CareRowland HeightsCalifornia91748-
Retinal Consultants Medical Group (RCMG) - Greenback Lane Retina CenterSacramentoCalifornia95841-
UC Davis Health Eye CenterSacramentoCalifornia95817-
Vrmg IncSacramentoCalifornia95825-
West Coast Retina Medical Group, Inc.San FranciscoCalifornia94109-
Orange County Retina Medical GroupSanta AnaCalifornia92705-
Macula Retina Vitreous Research InstituteTorranceCalifornia90503-
University of ColoradoAuroraColorado80045-
Retina Consultants of Southern ColoradoColorado SpringsColorado80909-
Retina Specialists of Colorado - DenverDenverColorado80222-
Southwest Retina Research CenterDurangoColorado81303-
Colorado Retina - LakewoodLakewoodColorado80228-
Eye care Center of Northern Colorado doing business as Advanced Vision Research InstituteLongmontColorado80503-
Retina Group of New EnglandWaterfordConnecticut06385-
Advanced Retina Institute-OphthalmologyBonita SpringsFlorida34134-
Advanced ResearchCoral SpringsFlorida33067-
Retina Group of FloridaFort LauderdaleFlorida33308-
National Ophthalmic Research InstituteFort MyersFlorida33912-
ClearVista Clinical Research, Retina Center Tampa BayHudsonFlorida34667-
Florida Retina Institute, Jacksonville Perimeter Park- OphthalmologyJacksonvilleFlorida32216-
Florida Retina ConsultantsLakelandFlorida33805-
Bascom Palmer Eye InstituteNaplesFlorida34103-
Florida Retina Institute - OrlandoOrlandoFlorida32806-
Retina Care SpecialistsPalm Beach GardensFlorida33410-
Eye Associates of PinellasPinellas ParkFlorida33782-
Retina Group of Florida, RAS-Sarasota Retina Center-OphthalmologySarasotaFlorida34232-
Retina Vitreous Associates of Florida Saint PetersburgSt. PetersburgFlorida33711-
University of South Florida OphthalmologyTampaFlorida33612-
Center for Retina and Macular DiseaseWinter HavenFlorida33880-
Southeast Retina CenterAugustaGeorgia30909-
Georgia Retina - MariettaMariettaGeorgia30060-
Retinal Vitreal ConsultantsChicagoIllinois60616-
The University of ChicagoChicagoIllinois60637-
University of Illinois at ChicagoChicagoIllinois60612-
University Retina and Macula Associates PC - LemontLemontIllinois60439-
Illinois Retina AssociatesOak ParkIllinois60304-
Springfield Clinic Main Campus EastSpringfieldIllinois62703-
Retina Associates, LLCLenexaKansas66215-
University of LouisvilleLouisvilleKentucky40202-
Retina Associates New OrleansMetairieLouisiana70006-
Ross Davis RetinaMetairieLouisiana70006-
Ochsner HealthNew OrleansLouisiana70121-
Eye Assoc. of NE LA dba Haik Humble Eye CtrWest MonroeLouisiana71291-
Eye Associates of Northeast Louisiana dba Haik Humble Eye CenterWest MonroeLouisiana71291-
The Retina Care CenterBaltimoreMaryland21209-
The Retina Group of WashingtonChevy ChaseMaryland20815-
Cumberland Valley Retina Consultants-OphthalmologyHagerstownMaryland21740-
Mid Atlantic Retina SpecialistHagerstownMaryland21740-
Massachusetts Eye And Ear InfirmaryBostonMassachusetts02114-
Opthalmic Consultants of BostonBostonMassachusetts02114-
New England Retina Consultants, PCSpringfieldMassachusetts01107-
Retina Associates of MichiganGrand BlancMichigan48439-
Mississippi Retina AssociatesMadisonMississippi39110-
Deep Blue Retina Clinical Research PLLCSouthavenMississippi38671-
Retina Research Institute, LLCSt LouisMissouri63144-
Mid Atlantic Retina - Cherry HillCherry HillNew Jersey08034-
New Jersey RetinaTeaneckNew Jersey07666-
New Jersey RetinaToms RiverNew Jersey08755-
University of New Mexico, HSCAlbuquerqueNew Mexico87131-
Vision Research Center at Eye Associates of New MexicoAlbuquerqueNew Mexico87109-
Sight MDBrentwoodNew York11717-
Retina Vitreous Surgeons of Central New York, PCLiverpoolNew York13088-
MaculaCare, PLLCNew YorkNew York10021-
New York Ear & Eye- East 85thNew YorkNew York10028-
Northwell Health- Manhattan, Ear, Eye and Throat Hospital- OphthalmologyNew YorkNew York10065-
Retina Associates of New York, Upper East SideNew YorkNew York10075-
Seeta Eye centerPoughkeepsieNew York12603-
Western Carolina Retinal AssociatesAshevilleNorth Carolina28803-
NC Retina AssociatesCaryNorth Carolina27511-
Graystone EyeHickoryNorth Carolina28602-
North Carolina Retina AssociatesWake ForestNorth Carolina27587-
Piedmont Retina SpecialistWinston-SalemNorth Carolina27103-
Cincinnati Eye InstituteCincinnatiOhio45242-
University Hospitals Cleveland Medical CenterClevelandOhio44106-
The Ohio State UniversityColumbusOhio43212-
Midwest Retina, IncDublinOhio43016-
Retina Vitreous Center - EdmondEdmondOklahoma73013-
Tulsa Retina ConsultantsTulsaOklahoma74114-
Verum Research LLCEugeneOregon97401-
EyeHealth NorthwestPortlandOregon97225-
OHSU-Casey Eye Institute, Marquam Hill-OphthalmologyPortlandOregon97239-
Retina Northwest, The Highlands BuildingPortlandOregon97221-
Cascade Medical Research Institute LLCSpringfieldOregon97477-
Mid Atlantic RetinaBethlehemPennsylvania18017-
Erie Retinal Surgery & Erie Retina ResearchEriePennsylvania16507-
Mid Atlantic Retina, Wills Eye HospitalPhiladelphiaPennsylvania19107-
Vision Research Solutions - the Eye InstitutePhiladelphiaPennsylvania19141-
Sewickley Eye GroupSewickleyPennsylvania15143-
Retina Consultants of CarolinaGreenvilleSouth Carolina29605-
Charleston Neuroscience Institute LLCLadsonSouth Carolina29456-
Charleston Neuroscience Institute, LLCMt. PleasantSouth Carolina29464-
Palmetto Retina CenterWest ColumbiaSouth Carolina29169-
Black Hills Regional Eye InstituteRapid CitySouth Dakota57701-
Tennessee Retina, PCNashvilleTennessee37203-
Vanderbilt Eye InstituteNashvilleTennessee37232-
Retina Research Institute of TexasAbileneTexas79606-
Austin Clinical Research LLCAustinTexas78750-
Austin Research Center for RetinaAustinTexas78705-
Austin Retina AssociatesAustinTexas78705-
Retina Consultants TexasBellaireTexas77401-
Star Retina PLLCBurlesonTexas76028-
Retina Foundation of the SouthwestDallasTexas75231-
Texas Retina AssociatesDallasTexas75231-
University of Texas Southwestern Medical CenterDallasTexas75390-
Retina Consultants of TexasKatyTexas77494-
Valley Retina Institute, P.A.McAllenTexas78503-
Red River Research Partners (Formerly AXIS Clinical)PlanoTexas75024-
Austin Retina AssociatesRound RockTexas78681-
Medical Center Ophthalmology AssociatesSan AntonioTexas78240-
Retina Associates of South TexasSan AntonioTexas78240-
Retina Consultants of TexasSan AntonioTexas78240-
Retina Consultants of Texas Brown Retina InstituteSan AntonioTexas78251-
Retina Center of TexasSouthlakeTexas76092-
Retina Consultants TexasThe WoodlandsTexas77384-
Tyler Retina Research Institute- OphthalmologyTylerTexas75703-
Retina Associates Of Utah Retina SpecialistSalt Lake CityUtah84107-
Rocky Mountain Retina ConsultantsSalt Lake CityUtah84107-
Salt Lake Retina- OphthalmologyWest JordanUtah84088-
University of VermontBurlingtonVermont05401-
Southeastern Retina AssociatesBristolVirginia24201-
Retina Group of WashingtonFairfaxVirginia22031-
Piedmont Eye CenterLynchburgVirginia24502-
Retina Institute of VirginiaRichmondVirginia23235-
Virginia Eye InstituteRichmondVirginia23226-
Spokane Eye Clinical ResearchSpokaneWashington99204-
West Virginia University Eye InstituteMorgantownWest Virginia26506-

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By research site
Barnet Dulaney Perkins Eye Center-Ophthamalogy· Chandler, AZAssociated Retina Consultants· Phoenix, AZBarnet Dulaney Perkins Eye Center· Phoenix, AZRetinal Research Institute· Phoenix, AZRetina Macula Institute of Arizona· Scottsdale, AZRetina Associates of Tuscan· Tucson, AZ

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