Clinical trial NCT06510816: A Study Investigating the Efficacy and Safety of Intravitreal (IVT) Injections of ANX007 in Participants With Geographic Atrophy (GA)
Official title: A Phase 3, Multicenter, Randomized, Parallel-Group, Double-Masked, 2-Arm, Sham Controlled Study of the Efficacy, Safety, and Tolerability of ANX007 Administered by Intravitreal Injection in Patients With Geographic Atrophy (GA) Secondary to Age Related Macular Degeneration (AMD)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Geographic Atrophy
Lead sponsor: Annexon, Inc.
Sponsor class: INDUSTRY
First posted: 2024-07-19
Enrollment: 630
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-masked
Primary purpose: TREATMENT

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).


Eligibility criteria: Inclusion Criteria:

* Diagnosis of GA of the macula secondary to AMD as determined by the Investigator and confirmed by the independent Central Reading Center.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Proportion of patients experiencing a best corrected visual acuity (BCVA) ≥15-letter loss from baseline through the primary timepoint as assessed by the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at any two consecutive visits.
timeFrame: 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 outcomes:
measure: Change From Baseline in the Hazard of ≥15 letter BCVA Loss Through Month 12 and Month 24
timeFrame: Baseline, Months 12 and 24
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Retina Macula Institute of Arizona
state: Arizona
city: Beverly Hills
country: United States
facility: Retina-Vitreous Associates Medical Group
state: California
city: Fullerton
country: United States
facility: RCOC Clinical Research Institute Inc
state: California
city: Glendale
country: United States
facility: Global Research Management
state: California
city: Modesto
country: United States
facility: Retina Consultants Medical Group
state: California
city: Mountain View
country: United States
facility: Northern California Retina Vitreous Associates Medical Group, Inc.
state: California
city: Poway
country: United States
facility: Retina Consultants of San Diego
state: California
city: Sacramento
country: United States
facility: Retinal Consultants Medical Group
state: California
city: Santa Barbara
country: United States
facility: California Retina Consultants- Santa Barbara
state: California
city: Torrance
country: United States
facility: Macula Retina Vitreous Research Institute
state: California
city: Walnut Creek
country: United States
facility: Bay Area Retina Associates
state: California
city: Colorado Springs
country: United States
facility: Retina Consultants of Southern Colorado PC
state: Colorado
city: Denver
country: United States
facility: RSC Research, LLC
state: Colorado
city: Manchester
country: United States
facility: Retina Consultants, P.C.
state: Connecticut
city: Deerfield Beach
country: United States
facility: Rand Eye Institute
state: Florida
city: Fort Myers
country: United States
facility: National Ophthalmic Research Institute
state: Florida
city: Jacksonville
country: United States
facility: Florida Retina Institute- Jacksonville
state: Florida
city: Orlando
country: United States
facility: Florida Retina Institute
state: Florida
city: Plantation
country: United States
facility: Fort Lauderdale Eye Institute
state: Florida
city: Saint Petersburg
country: United States
facility: Retina Vitreous Associates of Florida
state: Florida
city: Sarasota
country: United States
facility: Retina Group of Florida
state: Florida
city: Stuart
country: United States
facility: East Florida Eye Institute
state: Florida
city: Tallahassee
country: United States
facility: Southern Vitreoretinal Associates
state: Florida
city: Marietta
country: United States
facility: Georgia Retina PC
state: Georgia
city: 'Aiea
country: United States
facility: Retina Consultants of Hawaii
state: Hawaii
city: Elmhurst
country: United States
facility: Retina Associates - Elmhurst Location
state: Illinois
city: Oak Park
country: United States
facility: Illinois Retina Associates, S.C.
state: Illinois
city: Springfield
country: United States
facility: Springfield Clinic LLP
state: Illinois
city: West Des Moines
country: United States
facility: Wolfe Eye Clinic
state: Iowa
city: Lexington
country: United States
facility: Retina Associates of Kentucky
state: Kentucky
city: Portland
country: United States
facility: Maine Eye Center
state: Maine
city: Chevy Chase
country: United States
facility: Retina Group of Washington
state: Maryland
city: Hagerstown
country: United States
facility: Cumberland Valley Retina Consultants
state: Maryland
city: Hagerstown
country: United States
facility: Mid Atlantic Retina Specialists
state: Maryland
city: Boston
country: United States
facility: Ophthalmic Consultants of Boston
state: Massachusetts
city: Springfield
country: United States
facility: Retina Research Institute at New England Retina Consultants
state: Massachusetts
city: Saint Louis Park
country: United States
facility: Retina Consultants of Minnesota
state: Minnesota
city: Reno
country: United States
facility: Sierra Eye Associates
state: Nevada
city: Bloomfield
country: United States
facility: Envision Ocular, LLC
state: New Jersey
city: Cherry Hill
country: United States
facility: Mid Atlantic Retina
state: New Jersey
city: Albuquerque
country: United States
facility: Vision Research Center Eye Associates of New Mexico
state: New Mexico
city: Hauppauge
country: United States
facility: Long Island Vitreoretinal Consultants
state: New York
city: New York
country: United States
facility: Vitreous Retina Macula Consultants of NY (VRMNY)
state: New York
city: Asheville
country: United States
facility: Asheville Eye Associates - Retina Division
state: North Carolina
city: Wake Forest
country: United States
facility: North Carolina Retina Associates
state: North Carolina
city: Winston-Salem
country: United States
facility: Piedmont Retina Specialists - Winston Salem Office
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Edmond
country: United States
facility: Retina Vitreous Center
state: Oklahoma
city: Tulsa
country: United States
facility: Tulsa Retina Consultants
state: Oklahoma
city: Eugene
country: United States
facility: Verum Research, LLC
state: Oregon
city: Portland
country: United States
facility: Eyehealth Northwest Portland
state: Oregon
city: Springfield
country: United States
facility: Cascade Medical Research Institute
state: Oregon
city: Erie
country: United States
facility: Erie Retina Research, LLC
state: Pennsylvania
city: Kingston
country: United States
facility: Eye Care Specialists
state: Pennsylvania
city: Aiken
country: United States
facility: Palmetto Retina Center
state: South Carolina
city: Beaufort
country: United States
facility: ReƟna Consultants of Charleston
state: South Carolina
city: Charleston
country: United States
facility: Charleston Neuroscience Center
state: South Carolina
city: Abilene
country: United States
facility: Retina Research Institute of Texas
state: Texas
city: Amarillo
country: United States
facility: Southwest Retina Specialists
state: Texas
city: Arlington
country: United States
facility: Texas Retina Associates- Arlington
state: Texas
city: Austin
country: United States
facility: Austin Research Center for Retina
state: Texas
city: Austin
country: United States
facility: Austin Retina Associates
state: Texas
city: Austin
country: United States
facility: Austin Clinical Research, LLC
state: Texas
city: Bellaire
country: United States
facility: Retina Consultants of Texas
state: Texas
city: Dallas
country: United States
facility: Retina Foundation of the Southwest
state: Texas
city: Dallas
country: United States
facility: Texas Retina Associates - Plano
state: Texas
city: Fort Worth
country: United States
facility: Texas Retina Associates
state: Texas
city: Katy
country: United States
facility: Retina Consultants of Texas
state: Texas
city: Nashville
country: United States
facility: Tennessee Retina PC
state: Texas
city: San Antonio
country: United States
facility: Retina Consultants of Texas San Antonio
state: Texas
city: Schertz
country: United States
facility: Retina Consultants of Texas
state: Texas
city: The Woodlands
country: United States
facility: Retina Consultants of Texas
state: Texas
city: Willow Park
country: United States
facility: Strategic Clinical Research Group, LLC
state: Texas
city: Salt Lake City
country: United States
facility: Rocky Mountain Retina Consultants
state: Utah
city: West Jordan
country: United States
facility: Salt Lake Retina
state: Utah
city: Lynchburg
country: United States
facility: Piedmont Eye Center
state: Virginia
city: Wausau
country: United States
facility: Eye Clinic of Wisconsin
state: Wisconsin
city: Albury
country: Australia
facility: Eye Clinic Albury Wodonga
state: New South Wales
city: Melbourne
country: Australia
facility: Strathfield Retina Clinic
state: New South Wales
city: Parramatta
country: Australia
facility: Marsden Eye Specialists
state: New South Wales
city: Sydney
country: Australia
facility: Sydney Eye Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Sydney Retina Clinic and Day Surgery
state: New South Wales
city: Linz
country: Austria
facility: Kepler Universitätsklinikum
city: Calgary
country: Canada
facility: Calgary Retina Consultants
state: Alberta
city: Edmonton
country: Canada
facility: Alberta Retina Consultants
state: Alberta
city: London
country: Canada
facility: Ivey Eye Institute
state: Ontario
city: Ottawa
country: Canada
facility: Retina Centre of Ottawa
state: Ontario
city: Toronto
country: Canada
facility: Toronto Western Hospital -UHN
state: Ontario
city: Praha 10
country: Czechia
facility: Fakultní nemocnice Královské Vinohrady
city: Praha 5
country: Czechia
facility: Axon Clinical, s.r.o. Ocni Klinika
city: Creteil
country: France
facility: Service d'Ophtalmologie Centre Hospitalier Intercommunal de Créteil
city: Dijon Cedex
country: France
facility: CHU Dijon Bourgogne - Hôpital François Mitterrand
city: Neubrandenburg
country: Germany
facility: Dietrich Bonhoeffer Klinikum Klinik für Augenheilkunde
state: Mecklenburg Vorpommern
city: Muenster
country: Germany
facility: Augenzentrum am St. Franziskus-Hospital
state: North Rhine-Westphalia
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen, Department für Augenheilkunde
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Budapest
country: Hungary
facility: Budapest Retina Associates
city: Pecs
country: Hungary
facility: Ganglion Medical Center
city: Milano
country: Italy
facility: IRCCS Ospedale San Raffaele
city: Tilburg
country: Netherlands
facility: Elisabeth Hospital (ETZ) - location TweeSteden ziekenhuis
city: Christchurch
country: New Zealand
facility: Southern Eye Specialists
state: Canterbury
city: Te Aro
country: New Zealand
facility: Capital Eye Specialists
state: Wellington
city: Bydgoszcz
country: Poland
facility: Oftalmika Sp.Zo.O.
city: Olsztyn
country: Poland
facility: Centrum Diagnostyki I Mikrochirurgii Oka Lens Sp. Z O.O.
city: Tarnowskie Góry
country: Poland
facility: Caminomed Sp. Z O.O.
city: Warsaw
country: Poland
facility: Warszawski Szpital Okulistyczny
city: Valencia
country: Spain
facility: Oftalvist IMED Burjassot
state: Burjasso
city: Barcelona
country: Spain
facility: Institut Català de Retina
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Cordoba
country: Spain
facility: Hospital de la Arruzafa - Metavisión Arruzafa
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro - Majadahonda
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Zaragoza
country: Spain
facility: Hospital Clínico Universitario Lozano Blesa
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
city: London
country: United Kingdom
facility: Moorfields Eye Hospital NHS foundation Trust
city: London
country: United Kingdom
facility: The Retina Clinic
Study officials:
affiliation: Annexon, Inc.
name: Clinical Trials
role: STUDY_DIRECTOR
References: