A Study Investigating the Efficacy and Safety of Intravitreal (IVT) Injections of ANX007 in Participants With Geographic Atrophy (GA)
- Registration Number
- NCT06510816
- Lead Sponsor
- Annexon, Inc.
- Brief Summary
The primary purpose of the study is to determine if IVT injections of ANX007 every month reduce vision loss in participants with GA secondary to age-related macular degeneration (AMD).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 630
- Diagnosis of GA of the macula secondary to AMD as determined by the Investigator and confirmed by the independent Central Reading Center.
- Geographic atrophy due to other causes than AMD such as Stargardt disease, cone-rod dystrophy, pathologic myopia, or toxic maculopathies (for example, plaquenil maculopathy) in either eye.
NOTE: Other protocol-defined inclusion and exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ANX007 ANX007 Participants will receive ANX007 IVT injections every month during the 24-month treatment period. Sham Group Sham Administration Participants will receive Sham IVT injections every month during the 24-month treatment period.
- Primary Outcome Measures
Name Time Method Proportion of patients experiencing a best corrected visual acuity (BCVA) โฅ15-letter loss from baseline through the primary timepoint as assessed by the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at any two consecutive visits. The primary timepoint is based on accumulation of the target event rate, but no earlier than Month 12 and no later than Month 18
- Secondary Outcome Measures
Name Time Method Change From Baseline in the Hazard of โฅ15 letter BCVA Loss Through Month 12 and Month 24 Baseline, Months 12 and 24
Trial Locations
- Locations (114)
Retina Consultants of San Diego
๐บ๐ธPoway, California, United States
Verum Research, LLC
๐บ๐ธEugene, Oregon, United States
IRCCS Ospedale San Raffaele
๐ฎ๐นMilano, Italy
Centrum Diagnostyki I Mikrochirurgii Oka Lens Sp. Z O.O.
๐ต๐ฑOlsztyn, Poland
Retina Macula Institute of Arizona
๐บ๐ธScottsdale, Arizona, United States
Retina-Vitreous Associates Medical Group
๐บ๐ธBeverly Hills, California, United States
RCOC Clinical Research Institute Inc
๐บ๐ธFullerton, California, United States
Global Research Management
๐บ๐ธGlendale, California, United States
Retina Consultants Medical Group
๐บ๐ธModesto, California, United States
Northern California Retina Vitreous Associates Medical Group, Inc.
๐บ๐ธMountain View, California, United States
Retinal Consultants Medical Group
๐บ๐ธSacramento, California, United States
California Retina Consultants- Santa Barbara
๐บ๐ธSanta Barbara, California, United States
Macula Retina Vitreous Research Institute
๐บ๐ธTorrance, California, United States
Bay Area Retina Associates
๐บ๐ธWalnut Creek, California, United States
Retina Consultants of Southern Colorado PC
๐บ๐ธColorado Springs, Colorado, United States
RSC Research, LLC
๐บ๐ธDenver, Colorado, United States
Retina Consultants, P.C.
๐บ๐ธManchester, Connecticut, United States
Rand Eye Institute
๐บ๐ธDeerfield Beach, Florida, United States
National Ophthalmic Research Institute
๐บ๐ธFort Myers, Florida, United States
Florida Retina Institute- Jacksonville
๐บ๐ธJacksonville, Florida, United States
Florida Retina Institute
๐บ๐ธOrlando, Florida, United States
Fort Lauderdale Eye Institute
๐บ๐ธPlantation, Florida, United States
Retina Vitreous Associates of Florida
๐บ๐ธSaint Petersburg, Florida, United States
Retina Group of Florida
๐บ๐ธSarasota, Florida, United States
East Florida Eye Institute
๐บ๐ธStuart, Florida, United States
Southern Vitreoretinal Associates
๐บ๐ธTallahassee, Florida, United States
Georgia Retina PC
๐บ๐ธMarietta, Georgia, United States
Retina Consultants of Hawaii
๐บ๐ธ'Aiea, Hawaii, United States
Retina Associates - Elmhurst Location
๐บ๐ธElmhurst, Illinois, United States
Illinois Retina Associates, S.C.
๐บ๐ธOak Park, Illinois, United States
Springfield Clinic LLP
๐บ๐ธSpringfield, Illinois, United States
Wolfe Eye Clinic
๐บ๐ธWest Des Moines, Iowa, United States
Retina Associates of Kentucky
๐บ๐ธLexington, Kentucky, United States
Maine Eye Center
๐บ๐ธPortland, Maine, United States
Retina Group of Washington
๐บ๐ธChevy Chase, Maryland, United States
Cumberland Valley Retina Consultants
๐บ๐ธHagerstown, Maryland, United States
Mid Atlantic Retina Specialists
๐บ๐ธHagerstown, Maryland, United States
Ophthalmic Consultants of Boston
๐บ๐ธBoston, Massachusetts, United States
Retina Research Institute at New England Retina Consultants
๐บ๐ธSpringfield, Massachusetts, United States
Retina Consultants of Minnesota
๐บ๐ธSaint Louis Park, Minnesota, United States
Sierra Eye Associates
๐บ๐ธReno, Nevada, United States
Envision Ocular, LLC
๐บ๐ธBloomfield, New Jersey, United States
Mid Atlantic Retina
๐บ๐ธCherry Hill, New Jersey, United States
Vision Research Center Eye Associates of New Mexico
๐บ๐ธAlbuquerque, New Mexico, United States
Long Island Vitreoretinal Consultants
๐บ๐ธHauppauge, New York, United States
Vitreous Retina Macula Consultants of NY (VRMNY)
๐บ๐ธNew York, New York, United States
Asheville Eye Associates - Retina Division
๐บ๐ธAsheville, North Carolina, United States
North Carolina Retina Associates
๐บ๐ธWake Forest, North Carolina, United States
Piedmont Retina Specialists - Winston Salem Office
๐บ๐ธWinston-Salem, North Carolina, United States
University Hospitals Cleveland Medical Center
๐บ๐ธCleveland, Ohio, United States
Cleveland Clinic Foundation
๐บ๐ธCleveland, Ohio, United States
Retina Vitreous Center
๐บ๐ธEdmond, Oklahoma, United States
Tulsa Retina Consultants
๐บ๐ธTulsa, Oklahoma, United States
Eyehealth Northwest Portland
๐บ๐ธPortland, Oregon, United States
Cascade Medical Research Institute
๐บ๐ธSpringfield, Oregon, United States
Erie Retina Research, LLC
๐บ๐ธErie, Pennsylvania, United States
Eye Care Specialists
๐บ๐ธKingston, Pennsylvania, United States
Palmetto Retina Center
๐บ๐ธAiken, South Carolina, United States
Reฦna Consultants of Charleston
๐บ๐ธBeaufort, South Carolina, United States
Charleston Neuroscience Center
๐บ๐ธCharleston, South Carolina, United States
Retina Research Institute of Texas
๐บ๐ธAbilene, Texas, United States
Southwest Retina Specialists
๐บ๐ธAmarillo, Texas, United States
Texas Retina Associates- Arlington
๐บ๐ธArlington, Texas, United States
Austin Research Center for Retina
๐บ๐ธAustin, Texas, United States
Austin Retina Associates
๐บ๐ธAustin, Texas, United States
Austin Clinical Research, LLC
๐บ๐ธAustin, Texas, United States
Retina Consultants of Texas
๐บ๐ธThe Woodlands, Texas, United States
Retina Foundation of the Southwest
๐บ๐ธDallas, Texas, United States
Texas Retina Associates - Plano
๐บ๐ธDallas, Texas, United States
Texas Retina Associates
๐บ๐ธFort Worth, Texas, United States
Tennessee Retina PC
๐บ๐ธNashville, Texas, United States
Retina Consultants of Texas San Antonio
๐บ๐ธSan Antonio, Texas, United States
Strategic Clinical Research Group, LLC
๐บ๐ธWillow Park, Texas, United States
Rocky Mountain Retina Consultants
๐บ๐ธSalt Lake City, Utah, United States
Salt Lake Retina
๐บ๐ธWest Jordan, Utah, United States
Piedmont Eye Center
๐บ๐ธLynchburg, Virginia, United States
Eye Clinic of Wisconsin
๐บ๐ธWausau, Wisconsin, United States
Eye Clinic Albury Wodonga
๐ฆ๐บAlbury, New South Wales, Australia
Strathfield Retina Clinic
๐ฆ๐บMelbourne, New South Wales, Australia
Marsden Eye Specialists
๐ฆ๐บParramatta, New South Wales, Australia
Sydney Eye Hospital
๐ฆ๐บSydney, New South Wales, Australia
Sydney Retina Clinic and Day Surgery
๐ฆ๐บSydney, New South Wales, Australia
Kepler Universitรคtsklinikum
๐ฆ๐นLinz, Austria
Calgary Retina Consultants
๐จ๐ฆCalgary, Alberta, Canada
Alberta Retina Consultants
๐จ๐ฆEdmonton, Alberta, Canada
Ivey Eye Institute
๐จ๐ฆLondon, Ontario, Canada
Retina Centre of Ottawa
๐จ๐ฆOttawa, Ontario, Canada
Toronto Western Hospital -UHN
๐จ๐ฆToronto, Ontario, Canada
Fakultnรญ nemocnice Krรกlovskรฉ Vinohrady
๐จ๐ฟPraha 10, Czechia
Axon Clinical, s.r.o. Ocni Klinika
๐จ๐ฟPraha 5, Czechia
Service d'Ophtalmologie Centre Hospitalier Intercommunal de Crรฉteil
๐ซ๐ทCreteil, France
CHU Dijon Bourgogne - Hรดpital Franรงois Mitterrand
๐ซ๐ทDijon Cedex, France
Dietrich Bonhoeffer Klinikum Klinik fรผr Augenheilkunde
๐ฉ๐ชNeubrandenburg, Mecklenburg Vorpommern, Germany
Augenzentrum am St. Franziskus-Hospital
๐ฉ๐ชMuenster, North Rhine-Westphalia, Germany
Universitรคtsklinikum Tรผbingen, Department fรผr Augenheilkunde
๐ฉ๐ชTรผbingen, Germany
Semmelweis Egyetem
๐ญ๐บBudapest, Hungary
Budapest Retina Associates
๐ญ๐บBudapest, Hungary
Ganglion Medical Center
๐ญ๐บPecs, Hungary
Elisabeth Hospital (ETZ) - location TweeSteden ziekenhuis
๐ณ๐ฑTilburg, Netherlands
Southern Eye Specialists
๐ณ๐ฟChristchurch, Canterbury, New Zealand
Capital Eye Specialists
๐ณ๐ฟTe Aro, Wellington, New Zealand
Oftalmika Sp.Zo.O.
๐ต๐ฑBydgoszcz, Poland
Caminomed Sp. Z O.O.
๐ต๐ฑTarnowskie Gรณry, Poland
Warszawski Szpital Okulistyczny
๐ต๐ฑWarsaw, Poland
Oftalvist IMED Burjassot
๐ช๐ธValencia, Burjasso, Spain
Institut Catalร de Retina
๐ช๐ธBarcelona, Spain
Hospital Universitari Vall d'Hebron
๐ช๐ธBarcelona, Spain
Hospital de la Arruzafa - Metavisiรณn Arruzafa
๐ช๐ธCordoba, Spain
Hospital Universitario Puerta de Hierro - Majadahonda
๐ช๐ธMajadahonda, Spain
Hospital Universitario Virgen Macarena
๐ช๐ธSevilla, Spain
Hospital Clรญnico Universitario Lozano Blesa
๐ช๐ธZaragoza, Spain
Hospital Universitario Miguel Servet
๐ช๐ธZaragoza, Spain
Moorfields Eye Hospital NHS foundation Trust
๐ฌ๐งLondon, United Kingdom
The Retina Clinic
๐ฌ๐งLondon, United Kingdom