A Study Investigating the Efficacy and Safety of Intravitreal (IVT) Injections of Vonaprument (Formerly ANX007) in Participants With Dry Age-Related Macular Degeneration (AMD) With Geographic Atrophy (GA) (ARCHER II)

April 28, 2026 updated by: Annexon, Inc.

A Phase 3, Multicenter, Randomized, Parallel-Group, Double-Masked, 2-Arm, Sham Controlled Study of the Efficacy, Safety, and Tolerability of ANX007 (Vonaprument) Administered by Intravitreal Injection in Participants With Dry Age-Related Macular Degeneration With Geographic Atrophy

The primary purpose of the study is to determine if IVT injections of vonaprument every month reduce vision loss in participants with dry AMD with GA.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

659

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Albury, New South Wales, Australia, 2640
        • Eye Clinic Albury Wodonga
      • Parramatta, New South Wales, Australia, 2150
        • Marsden Eye Specialists
      • Strathfield, New South Wales, Australia, 2135
        • Strathfield Retina Clinic
      • Sydney, New South Wales, Australia, 2000
        • Sydney Eye Hospital
      • Sydney, New South Wales, Australia, 2000
        • Sydney Retina Clinic and Day Surgery
  • Austria
      • Klagenfurt, Austria, 9020
        • Klinikum Klagenfurt am Worthersee
      • Linz, Austria, 4020
        • Kepler Universitätsklinikum
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2H 0C8
        • Calgary Retina Consultants
      • Edmonton, Alberta, Canada, T5H 0X5
        • Alberta Retina Consultants
    • Ontario
      • London, Ontario, Canada, N6A 4V2
        • Ivey Eye Institute
      • Ottawa, Ontario, Canada, K2B 7E9
        • Retina Centre of Ottawa
  • Czechia
      • Prague, Czechia, 128 08
        • Vseobecna fakultni nemocnice v Praze
      • Prague, Czechia, 100 34
        • Fakultni nemocnice Kralovske Vinohrady
      • Prague, Czechia, 150 00
        • Axon Clinical, s.r.o. Ocni Klinika
  • France
      • Bordeaux, France, 33076
        • Groupe Hospitalier Pellegrin - CHU de Bordeaux
      • Créteil, France, 94000
        • Centre Hospitalier Intercommunal de Creteil
      • Dijon, France, 21079
        • CHU Dijon Bourgogne - Hopital Francois Mitterrand
      • Marseille, France
        • Centre Monticelli Paradis d'Ophtalmologie
      • Nice, France, 06001
        • Centre Hospitalier Universitaire de Nice
      • Paris, France, 75010
        • Hôpital Lariboisière - Service d'ophtalmologie
      • Strasbourg, France, 67000
        • Centre Ophtalmologique Maison Rouge
      • Écully, France
        • Centre Ophtalmologique Pôle Vision Val d'Ouest
  • Germany
      • Bonn, Germany, 53127
        • Universitäts-Klinikum Bonn
      • Heidelberg, Germany, 69120
        • UniversitatsKlinikum Heidelberg
      • Tübingen, Germany, 72076
        • Universitätsklinikum Tübingen, Department für Augenheilkunde
    • Mecklenburg-Vorpommern
      • Neubrandenburg, Mecklenburg-Vorpommern, Germany, 17036
        • Dietrich Bonhoeffer Klinikum Klinik für Augenheilkunde
    • North Rhine-Westphalia
      • Münster, North Rhine-Westphalia, Germany, 48145
        • Augenzentrum am St. Franziskus-Hospital
  • Hungary
      • Budapest, Hungary, 1085
        • Semmelweis Egyetem
      • Budapest, Hungary, 1133
        • Budapest Retina Associates
      • Budapest, Hungary, 1106
        • Budapesti Bajcsy-Zsilinszky Kórház és Rendelőintézet Szemészet Osztály
    • Baranya
      • Pécs, Baranya, Hungary, 7621
        • Ganglion Medical Center
    • Hajdú-Bihar
      • Debrecen, Hajdú-Bihar, Hungary, 4032
        • Debreceni Egyetem Klinikai Kozpont Nagyerdei Campus
  • Italy
      • Florence, Italy, 50134
        • Azienda Ospedaliera Universitaria Careggi
      • Milan, Italy, 20122
        • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
      • Milan, Italy, 20132
        • IRCCS Ospedale San Raffaele
      • Milan, Italy, 20157
        • ASST Fatebenefratelli Sacco
      • Milan, Italy, 20123
        • IRCCS MultiMedica
      • Roma, Italy, 00184
        • Fondazione G.B. Bietti Per Lo Sudio E La Ricerca In Oftalmologia - Presidio
      • Rome, Italy, 00133
        • Fondazione PTV Policlinico Tor Vergata
      • Rome, Italy, 00168
        • Fondazione Policlinico Agostino Gemelli
  • Netherlands
      • Tilburg, Netherlands, 5042 AD
        • Elisabeth Hospital (ETZ) - location TweeSteden ziekenhuis
  • New Zealand
    • Canterbury
      • Christchurch, Canterbury, New Zealand, 8013
        • Southern Eye Specialists
    • Wellington Region
      • Te Aro, Wellington Region, New Zealand, 6011
        • Capital Eye Specialists
  • Poland
      • Bydgoszcz, Poland, 85-631
        • Oftalmika Sp.Zo.O.
      • Olsztyn, Poland, 10-424
        • Centrum Diagnostyki I Mikrochirurgii Oka Lens Sp. Z O.O.
      • Rzeszów, Poland, 35-017
        • Ośrodek Chirurgii Oka Prof. Zagórskiego Sp. Z o.o.
      • Tarnowskie Góry, Poland, 42-600
        • Caminomed Sp. z o.o.
      • Warsaw, Poland, 01-258
        • Warszawski Szpital Okulistyczny
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron
      • Barcelona, Spain, 08017
        • Institut Català de Retina
      • Córdoba, Spain, 14012
        • Hospital de la Arruzafa - Metavisión Arruzafa
      • Madrid, Spain, 28046
        • Clinica Baviera
      • Majadahonda, Spain, 28222
        • Hospital Universitario Puerta de Hierro - Majadahonda
      • Sant Cugat del Vallès, Spain, 08195
        • Hospital Universitari General de Catalunya - Valles Ophthalmology Research - OMIQ Research
      • Santiago de Compostela, Spain, 15706
        • Hospital Clínico Universitario de Santiago
      • Seville, Spain, 41009
        • Hospital Universitario Virgen Macarena
      • Zaragoza, Spain, 50009
        • Hospital Universitario Miguel Servet
    • Burjassot
      • Valencia, Burjassot, Spain, 46100
        • Oftalvist IMED Burjassot
  • United Kingdom
      • London, United Kingdom, SE5 9RS
        • King's College Hospital
      • London, United Kingdom, W1G 9AX
        • The Retina Clinic London
    • London
      • Greater London, London, United Kingdom, EC1V 2PD
        • Moorfields Eye Hospital NHS Foundation Trust
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85255
        • Retina Macula Institute of Arizona
    • California
      • Beverly Hills, California, United States, 90211
        • Retina-Vitreous Associates Medical Group
      • Fullerton, California, United States, 92835
        • Retinal Consultants of Orange County Clinical Research Institute Inc
      • Glendale, California, United States, 91204
        • Global Research Management
      • Modesto, California, United States, 95356
        • Retina Consultants Medical Group
      • Mountain View, California, United States, 94040
        • Northern California Retina Vitreous Associates Medical Group, Inc.
      • Sacramento, California, United States, 95825
        • Retinal Consultants Medical Group
      • Torrance, California, United States, 90503
        • Macula Retina Vitreous Research Institute
      • Walnut Creek, California, United States, 94598
        • Bay Area Retina Associates
    • Colorado
      • Colorado Springs, Colorado, United States, 80909
        • Retina Consultants of Southern Colorado PC
      • Denver, Colorado, United States, 80222
        • RSC Research, LLC
    • Florida
      • Deerfield Beach, Florida, United States, 33064
        • Rand Eye Institute
      • Fort Myers, Florida, United States, 33912
        • National Ophthalmic Research Institute
      • Orlando, Florida, United States, 32806
        • Florida Retina Institute
      • Plantation, Florida, United States, 33324
        • Fort Lauderdale Eye Institute
      • Sarasota, Florida, United States, 34232
        • Retina Group of Florida
      • St. Petersburg, Florida, United States, 33711
        • Retina Vitreous Associates of Florida
      • Stuart, Florida, United States, 34994
        • East Florida Eye Institute
      • Tampa, Florida, United States, 33609
        • Retina Associates of Florida
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Georgia Retina PC
    • Hawaii
      • ‘Aiea, Hawaii, United States, 96701
        • Retina Consultants Of Hawaii
    • Illinois
      • Elmhurst, Illinois, United States, 60126
        • Retina Associates Ltd
      • Oak Forest, Illinois, United States, 60452
        • University Retina
      • Springfield, Illinois, United States, 62703
        • Springfield Clinic LLP
    • Iowa
      • West Des Moines, Iowa, United States, 50266
        • Wolfe Eye Clinic
    • Maine
      • Portland, Maine, United States, 04101
        • Maine Eye Center
    • Maryland
      • Chevy Chase, Maryland, United States, 20815
        • Retina Group of Washington
      • Hagerstown, Maryland, United States, 21740
        • Cumberland Valley Retina Consultants
      • Hagerstown, Maryland, United States, 21740
        • Mid Atlantic Retina Specialists
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Ophthalmic Consultants of Boston
      • Springfield, Massachusetts, United States, 01107
        • Retina Research Institute at New England Retina Consultants
    • Minnesota
      • Saint Louis Park, Minnesota, United States, 55416
        • Retina Consultants of Minnesota
    • Nevada
      • Reno, Nevada, United States, 89502
        • Sierra Eye Associates
    • New Jersey
      • Bloomfield, New Jersey, United States, 07003
        • Envision Ocular, LLC
      • Cherry Hill, New Jersey, United States, 08054
        • Mid Atlantic Retina New Jersey
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Vision Research Center Eye Associates of New Mexico
    • New York
      • Hauppauge, New York, United States, 11788
        • Long Island Vitreoretinal Consultants
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Asheville Eye Associates - Retina Division
      • Cary, North Carolina, United States, 27511
        • North Carolina Retina Associates
      • Wake Forest, North Carolina, United States, 27587
        • North Carolina Retina Associates
      • Winston-Salem, North Carolina, United States, 27103
        • Piedmont Retina Specialists
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Cleveland Medical Center
    • Oklahoma
      • Edmond, Oklahoma, United States, 73013
        • Retina Vitreous Center
      • Tulsa, Oklahoma, United States, 74114
        • Tulsa Retina Consultants
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Verum Research, LLC
      • Portland, Oregon, United States, 97209
        • Eyehealth Northwest Portland
      • Springfield, Oregon, United States, 97477
        • Cascade Medical Research Institute
    • Pennsylvania
      • Erie, Pennsylvania, United States, 16507
        • Erie Retina Research, LLC
      • Kingston, Pennsylvania, United States, 18704
        • Eye Care Specialists
    • South Carolina
      • Aiken, South Carolina, United States, 29802
        • Palmetto Retina Center
      • Beaufort, South Carolina, United States, 29901
        • Retina Consultants of Charleston
      • Charleston, South Carolina, United States, 29414
        • Charleston Neuroscience Center
    • Tennessee
      • Johnson City, Tennessee, United States, 37604
        • Southeastern Retina Associates
    • Texas
      • Abilene, Texas, United States, 79606
        • Retina Research Institute of Texas
      • Amarillo, Texas, United States, 79106
        • Southwest Retina Specialists
      • Arlington, Texas, United States, 76012
        • Texas Retina Associates- Arlington
      • Austin, Texas, United States, 78705
        • Austin Retina Associates
      • Austin, Texas, United States, 78705
        • Austin Research Center for Retina
      • Austin, Texas, United States, 78750
        • Austin Clinical Research, LLC
      • Bellaire, Texas, United States, 77401
        • Retina Consultants of Texas
      • Dallas, Texas, United States, 75231
        • Texas Retina Associates
      • Dallas, Texas, United States, 75231
        • Retina Foundation of the Southwest
      • Fort Worth, Texas, United States, 76104
        • Texas Retina Associates
      • Katy, Texas, United States, 77494
        • Retina Consultants of Texas
      • Nashville, Texas, United States, 37203
        • Tennessee Retina PC
      • San Antonio, Texas, United States, 78240
        • Retina Consultants of Texas San Antonio
      • The Woodlands, Texas, United States, 77384
        • Retina Consultants of Texas
      • Willow Park, Texas, United States, 76087
        • Strategic Clinical Research Group, LLC
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Rocky Mountain Retina Consultants
    • Virginia
      • Lynchburg, Virginia, United States, 24502
        • Piedmont Eye Center
    • Wisconsin
      • Wausau, Wisconsin, United States, 54403
        • Eye Clinic of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of dry AMD with GA 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 apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Sham Group
Participants will receive Sham IVT injections every month during the 24-month treatment period.
Other: 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).
Experimental: Vonaprument
Participants will receive vonaprument IVT injections every month during the 24-month treatment period.
Drug: Vonaprument
Form: solution for injection; Route of Administration: IVT injection
Other Names:
  • ANX007

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of Participants Experiencing a Best Corrected Visual Acuity (BCVA) ≥15-letter Loss from Baseline Through Month 15 as Assessed by the Early Treatment Diabetic Retinopathy Study (ETDRS) Chart at Any Two Consecutive Visits
Time Frame: Baseline through Month 15
Baseline through Month 15

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to Confirmed BCVA ≥15-letter Loss
Time Frame: Baseline to Month 15 and Baseline to Month 24
Baseline to Month 15 and Baseline to Month 24
Proportion of Participants Experiencing a Confirmed BCVA ≥15-letter Loss
Time Frame: Baseline through Month 24
Baseline through Month 24
Proportion of Participants with Low-luminance BCVA (LLVA) ≥15-letter Loss
Time Frame: Baseline through Month 15 and Baseline through Month 24
Baseline through Month 15 and Baseline through Month 24
Change from Baseline in Area of Total Loss of the Ellipsoid Zone (EZ) Layer
Time Frame: Baseline, Month 15 and 24
Baseline, Month 15 and 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Annexon, Inc.

Investigators

  • Study Director: Clinical Trials, Annexon, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 30, 2024

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

July 31, 2027

Study Registration Dates

First Submitted

July 15, 2024

First Submitted That Met QC Criteria

July 15, 2024

First Posted (Actual)

July 19, 2024

Study Record Updates

Last Update Posted (Actual)

May 4, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANX007-GA-02
  • 2024-515022-88-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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