A Study Investigating the Efficacy and Safety of Intravitreal (IVT) Injections of Vonaprument (Formerly ANX007) in Participants With Geographic Atrophy (GA)

NCT ID: NCT06510816

Last Updated: 2025-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

659 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-30

Study Completion Date

2027-10-31

Brief Summary

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The primary purpose of the study is to determine if IVT injections of vonaprument every month reduce vision loss in participants with GA secondary to age-related macular degeneration (AMD).

Detailed Description

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Conditions

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Geographic Atrophy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double-masked
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Vonaprument

Participants will receive vonaprument IVT injections every month during the 24-month treatment period.

Group Type EXPERIMENTAL

Vonaprument

Intervention Type DRUG

Form: solution for injection; Route of Administration: IVT injection

Sham Group

Participants will receive Sham IVT injections every month during the 24-month treatment period.

Group Type SHAM_COMPARATOR

Sham Administration

Intervention Type OTHER

Form and Route of Administration: to mimic IVT injection (includes placement of the blunt opening of an empty, needleless syringe barrel on the conjunctiva in the inferotemporal quadrant of the eyeball to stimulate the pressure of an injection).

Interventions

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Vonaprument

Form: solution for injection; Route of Administration: IVT injection

Intervention Type DRUG

Sham Administration

Form and Route of Administration: to mimic IVT injection (includes placement of the blunt opening of an empty, needleless syringe barrel on the conjunctiva in the inferotemporal quadrant of the eyeball to stimulate the pressure of an injection).

Intervention Type OTHER

Other Intervention Names

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ANX007

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Annexon, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Annexon, Inc.

Locations

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Retina Macula Institute of Arizona

Scottsdale, Arizona, United States

Site Status

Retina-Vitreous Associates Medical Group

Beverly Hills, California, United States

Site Status

RCOC Clinical Research Institute Inc

Fullerton, California, United States

Site Status

Global Research Management

Glendale, California, United States

Site Status

Retina Consultants Medical Group

Modesto, California, United States

Site Status

Northern California Retina Vitreous Associates Medical Group, Inc.

Mountain View, California, United States

Site Status

Retinal Consultants Medical Group

Sacramento, California, United States

Site Status

Macula Retina Vitreous Research Institute

Torrance, California, United States

Site Status

Bay Area Retina Associates

Walnut Creek, California, United States

Site Status

Retina Consultants of Southern Colorado PC

Colorado Springs, Colorado, United States

Site Status

RSC Research, LLC

Denver, Colorado, United States

Site Status

Rand Eye Institute

Deerfield Beach, Florida, United States

Site Status

National Ophthalmic Research Institute

Fort Myers, Florida, United States

Site Status

Florida Retina Institute

Orlando, Florida, United States

Site Status

Fort Lauderdale Eye Institute

Plantation, Florida, United States

Site Status

Retina Group of Florida

Sarasota, Florida, United States

Site Status

Retina Vitreous Associates of Florida

St. Petersburg, Florida, United States

Site Status

East Florida Eye Institute

Stuart, Florida, United States

Site Status

Georgia Retina PC

Marietta, Georgia, United States

Site Status

Retina Consultants of Hawaii

‘Aiea, Hawaii, United States

Site Status

Retina Associates - Elmhurst Location

Elmhurst, Illinois, United States

Site Status

University Retina

Oak Forest, Illinois, United States

Site Status

Springfield Clinic LLP

Springfield, Illinois, United States

Site Status

Wolfe Eye Clinic

West Des Moines, Iowa, United States

Site Status

Maine Eye Center

Portland, Maine, United States

Site Status

Retina Group of Washington

Chevy Chase, Maryland, United States

Site Status

Cumberland Valley Retina Consultants

Hagerstown, Maryland, United States

Site Status

Mid Atlantic Retina Specialists

Hagerstown, Maryland, United States

Site Status

Ophthalmic Consultants of Boston

Boston, Massachusetts, United States

Site Status

Retina Research Institute at New England Retina Consultants

Springfield, Massachusetts, United States

Site Status

Retina Consultants of Minnesota

Saint Louis Park, Minnesota, United States

Site Status

Sierra Eye Associates

Reno, Nevada, United States

Site Status

Envision Ocular, LLC

Bloomfield, New Jersey, United States

Site Status

Mid Atlantic Retina

Cherry Hill, New Jersey, United States

Site Status

Vision Research Center Eye Associates of New Mexico

Albuquerque, New Mexico, United States

Site Status

Long Island Vitreoretinal Consultants

Hauppauge, New York, United States

Site Status

Asheville Eye Associates - Retina Division

Asheville, North Carolina, United States

Site Status

North Carolina Retina Associates

Cary, North Carolina, United States

Site Status

North Carolina Retina Associates

Wake Forest, North Carolina, United States

Site Status

Piedmont Retina Specialists - Winston Salem Office

Winston-Salem, North Carolina, United States

Site Status

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Site Status

Retina Vitreous Center

Edmond, Oklahoma, United States

Site Status

Tulsa Retina Consultants

Tulsa, Oklahoma, United States

Site Status

Verum Research, LLC

Eugene, Oregon, United States

Site Status

Eyehealth Northwest Portland

Portland, Oregon, United States

Site Status

Cascade Medical Research Institute

Springfield, Oregon, United States

Site Status

Erie Retina Research, LLC

Erie, Pennsylvania, United States

Site Status

Eye Care Specialists

Kingston, Pennsylvania, United States

Site Status

Palmetto Retina Center

Aiken, South Carolina, United States

Site Status

ReƟna Consultants of Charleston

Beaufort, South Carolina, United States

Site Status

Charleston Neuroscience Center

Charleston, South Carolina, United States

Site Status

Southeastern Retina

Chattanooga, Tennessee, United States

Site Status

Retina Research Institute of Texas

Abilene, Texas, United States

Site Status

Southwest Retina Specialists

Amarillo, Texas, United States

Site Status

Texas Retina Associates- Arlington

Arlington, Texas, United States

Site Status

Austin Research Center for Retina

Austin, Texas, United States

Site Status

Austin Retina Associates

Austin, Texas, United States

Site Status

Austin Clinical Research, LLC

Austin, Texas, United States

Site Status

Retina Consultants of Texas

Bellaire, Texas, United States

Site Status

Retina Foundation of the Southwest

Dallas, Texas, United States

Site Status

Texas Retina Associates - Plano

Dallas, Texas, United States

Site Status

Texas Retina Associates

Fort Worth, Texas, United States

Site Status

Retina Consultants of Texas

Katy, Texas, United States

Site Status

Tennessee Retina PC

Nashville, Texas, United States

Site Status

Retina Consultants of Texas San Antonio

San Antonio, Texas, United States

Site Status

Retina Consultants of Texas

The Woodlands, Texas, United States

Site Status

Strategic Clinical Research Group, LLC

Willow Park, Texas, United States

Site Status

Rocky Mountain Retina Consultants

Salt Lake City, Utah, United States

Site Status

Piedmont Eye Center

Lynchburg, Virginia, United States

Site Status

Eye Clinic of Wisconsin

Wausau, Wisconsin, United States

Site Status

Eye Clinic Albury Wodonga

Albury, New South Wales, Australia

Site Status

Strathfield Retina Clinic

Melbourne, New South Wales, Australia

Site Status

Marsden Eye Specialists

Parramatta, New South Wales, Australia

Site Status

Sydney Eye Hospital

Sydney, New South Wales, Australia

Site Status

Sydney Retina Clinic and Day Surgery

Sydney, New South Wales, Australia

Site Status

Klinikum Klagenfurt am Wörthersee

Klagenfurt, , Austria

Site Status

Kepler Universitätsklinikum

Linz, , Austria

Site Status

Calgary Retina Consultants

Calgary, Alberta, Canada

Site Status

Alberta Retina Consultants

Edmonton, Alberta, Canada

Site Status

Ivey Eye Institute

London, Ontario, Canada

Site Status

Retina Centre of Ottawa

Ottawa, Ontario, Canada

Site Status

Fakultní nemocnice Královské Vinohrady

Prague, , Czechia

Site Status

Všeobecná fakultní nemocnice V Praze

Prague, , Czechia

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Axon Clinical, s.r.o. Ocni Klinika

Prague, , Czechia

Site Status

Groupe Hospitalier Pellegrin - CHU de Bordeaux

Bordeaux, , France

Site Status

Service d'Ophtalmologie Centre Hospitalier Intercommunal de Créteil

Créteil, , France

Site Status

CHU Dijon Bourgogne - Hôpital François Mitterrand

Dijon, , France

Site Status

Centre Ophtalmologique Pôle Vision Val d'Ouest

Écully, , France

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Centre Monticelli Paradis d'Ophtalmologie

Marseille, , France

Site Status

Centre Hospitalier Universitaire de Nice

Nice, , France

Site Status

Hôpital Lariboisière - Service d'ophtalmologie

Paris, , France

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Centre Ophtalmologique Maison Rouge

Strasbourg, , France

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Dietrich Bonhoeffer Klinikum Klinik für Augenheilkunde

Neubrandenburg, Mecklenburg-Vorpommern, Germany

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Augenzentrum am St. Franziskus-Hospital

Münster, North Rhine-Westphalia, Germany

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Uni-Augenklinik Bonn

Bonn, , Germany

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Universitätsklinikum Heidelberg

Heidelberg, , Germany

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Universitätsklinikum Tübingen, Department für Augenheilkunde

Tübingen, , Germany

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Semmelweis Egyetem

Budapest, , Hungary

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Budapest Retina Associates

Budapest, , Hungary

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Debreceni Egyetem Klinikai Kozpont Nagyerdei Campus

Debrecen, , Hungary

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Ganglion Medical Center

Pécs, , Hungary

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Azienda Ospedaliera Universitaria Careggi

Florence, , Italy

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IRCCS MultiMedica

Milan, , Italy

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ASST Fatebenefratelli Sacco

Milan, , Italy

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Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

Milan, , Italy

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IRCCS Ospedale San Raffaele

Milan, , Italy

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Fondazione G.B. Bietti Per Lo Sudio E La Ricerca In Oftalmologia - Presidio

Roma, , Italy

Site Status

Fondazione PTV Policlinico Tor Vergata

Rome, , Italy

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Fondazione Policlinico Agostino Gemelli

Rome, , Italy

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Elisabeth Hospital (ETZ) - location TweeSteden ziekenhuis

Tilburg, , Netherlands

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Southern Eye Specialists

Christchurch, Canterbury, New Zealand

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Capital Eye Specialists

Te Aro, Wellington Region, New Zealand

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Oftalmika Sp.Zo.O.

Bydgoszcz, , Poland

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Centrum Diagnostyki I Mikrochirurgii Oka Lens Sp. Z O.O.

Olsztyn, , Poland

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Ośrodek Chirurgii Oka Prof. Zagórskiego Sp. Z o.o.

Rzeszów, , Poland

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Caminomed Sp. Z O.O.

Tarnowskie Góry, , Poland

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Warszawski Szpital Okulistyczny

Warsaw, , Poland

Site Status

Oftalvist IMED Burjassot

Valencia, Burjasso, Spain

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Institut Català de Retina

Barcelona, , Spain

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Hospital Universitari Vall d'Hebron

Barcelona, , Spain

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Hospital de la Arruzafa - Metavisión Arruzafa

Córdoba, , Spain

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Clínica Baviera

Madrid, , Spain

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Hospital Universitario Puerta de Hierro - Majadahonda

Majadahonda, , Spain

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Hospital Universitari General de Catalunya - Grupo Quironsalud

Sant Cugat del Vallès, , Spain

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Hospital Clinico Universitario de Santiago

Santiago de Compostela, , Spain

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Hospital Universitario Virgen Macarena

Seville, , Spain

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Hospital Universitario Miguel Servet

Zaragoza, , Spain

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Moorfields Eye Hospital NHS foundation Trust

London, , United Kingdom

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King's College Hospital

London, , United Kingdom

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The Retina Clinic

London, , United Kingdom

Site Status

Countries

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United States Australia Austria Canada Czechia France Germany Hungary Italy Netherlands New Zealand Poland Spain United Kingdom

Other Identifiers

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2024-515022-88-00

Identifier Type: CTIS

Identifier Source: secondary_id

ANX007-GA-02

Identifier Type: -

Identifier Source: org_study_id