Geographic AtrophyPhase 3ARCHER IINCT06510816
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)
A Phase 3 study testing Vonaprument in people with Geographic Atrophy, run by Annexon, Inc. at 132 sites in 14 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Geographic Atrophy
- What is being tested?
- Vonaprument
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 659 participants
- Where
- 132 sitesin 14 countries
- Study dates
- 30 Jul 2024to 31 Jul 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of dry AMD with GA as determined by the Investigator and confirmed by the independent Central Reading Center.
Who cannot join
- 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.
Trial locations and contacts
132 sites in 14 countries.
132 sites in 14 countries
United States71 sites
Retina Consultants of Hawaii
‘Aiea, Hawaii, 96701
Retina Research Institute of Texas
Abilene, Texas, 79606
Palmetto Retina Center
Aiken, South Carolina, 29802
Vision Research Center Eye Associates of New Mexico
Albuquerque, New Mexico, 87109
Southwest Retina Specialists
Amarillo, Texas, 79106
Texas Retina Associates- Arlington
Arlington, Texas, 76012
Asheville Eye Associates - Retina Division
Asheville, North Carolina, 28803
Austin Research Center for Retina
Austin, Texas, 78705
Austin Retina Associates
Austin, Texas, 78705
Austin Clinical Research, LLC
Austin, Texas, 78750
Retina Consultants of Charleston
Beaufort, South Carolina, 29901
Retina Consultants of Texas
Bellaire, Texas, 77401
Retina-Vitreous Associates Medical Group
Beverly Hills, California, 90211
Envision Ocular, LLC
Bloomfield, New Jersey, 07003
Ophthalmic Consultants of Boston
Boston, Massachusetts, 02114
North Carolina Retina Associates
Cary, North Carolina, 27511
Charleston Neuroscience Center
Charleston, South Carolina, 29414
Mid Atlantic Retina New Jersey
Cherry Hill, New Jersey, 08054
Retina Group of Washington
Chevy Chase, Maryland, 20815
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Retina Consultants of Southern Colorado PC
Colorado Springs, Colorado, 80909
Retina Foundation of the Southwest
Dallas, Texas, 75231
Texas Retina Associates
Dallas, Texas, 75231
Rand Eye Institute
Deerfield Beach, Florida, 33064
RSC Research, LLC
Denver, Colorado, 80222
Retina Vitreous Center
Edmond, Oklahoma, 73013
Retina Associates Ltd
Elmhurst, Illinois, 60126
Erie Retina Research, LLC
Erie, Pennsylvania, 16507
Verum Research, LLC
Eugene, Oregon, 97401
National Ophthalmic Research Institute
Fort Myers, Florida, 33912
Texas Retina Associates
Fort Worth, Texas, 76104
Retinal Consultants of Orange County Clinical Research Institute Inc
Fullerton, California, 92835
Global Research Management
Glendale, California, 91204
Cumberland Valley Retina Consultants
Hagerstown, Maryland, 21740
Mid Atlantic Retina Specialists
Hagerstown, Maryland, 21740
Long Island Vitreoretinal Consultants
Hauppauge, New York, 11788
Southeastern Retina Associates
Johnson City, Tennessee, 37604
Retina Consultants of Texas
Katy, Texas, 77494
Eye Care Specialists
Kingston, Pennsylvania, 18704
Piedmont Eye Center
Lynchburg, Virginia, 24502
Georgia Retina PC
Marietta, Georgia, 30060
Retina Consultants Medical Group
Modesto, California, 95356
Northern California Retina Vitreous Associates Medical Group, Inc.
Mountain View, California, 94040
Tennessee Retina PC
Nashville, Texas, 37203
University Retina
Oak Forest, Illinois, 60452
Florida Retina Institute
Orlando, Florida, 32806
Fort Lauderdale Eye Institute
Plantation, Florida, 33324
Maine Eye Center
Portland, Maine, 04101
Eyehealth Northwest Portland
Portland, Oregon, 97209
Sierra Eye Associates
Reno, Nevada, 89502
Retinal Consultants Medical Group
Sacramento, California, 95825
Retina Consultants of Minnesota
Saint Louis Park, Minnesota, 55416
Rocky Mountain Retina Consultants
Salt Lake City, Utah, 84107
Retina Consultants of Texas San Antonio
San Antonio, Texas, 78240
Retina Group of Florida
Sarasota, Florida, 34232
Retina Macula Institute of Arizona
Scottsdale, Arizona, 85255
Springfield Clinic LLP
Springfield, Illinois, 62703
Retina Research Institute at New England Retina Consultants
Springfield, Massachusetts, 01107
Cascade Medical Research Institute
Springfield, Oregon, 97477
Retina Vitreous Associates of Florida
St. Petersburg, Florida, 33711
East Florida Eye Institute
Stuart, Florida, 34994
Retina Associates of Florida
Tampa, Florida, 33609
Retina Consultants of Texas
The Woodlands, Texas, 77384
Macula Retina Vitreous Research Institute
Torrance, California, 90503
Tulsa Retina Consultants
Tulsa, Oklahoma, 74114
North Carolina Retina Associates
Wake Forest, North Carolina, 27587
Bay Area Retina Associates
Walnut Creek, California, 94598
Eye Clinic of Wisconsin
Wausau, Wisconsin, 54403
Wolfe Eye Clinic
West Des Moines, Iowa, 50266
Strategic Clinical Research Group, LLC
Willow Park, Texas, 76087
Piedmont Retina Specialists
Winston-Salem, North Carolina, 27103
Spain10 sites
Institut Català de Retina
Barcelona, 08017
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Hospital de la Arruzafa - Metavisión Arruzafa
Córdoba, 14012
Clínica Baviera
Madrid, 28046
Hospital Universitario Puerta de Hierro - Majadahonda
Majadahonda, 28222
Hospital Universitari General de Catalunya - Valles Ophthalmology Research - OMIQ Research
Sant Cugat del Vallès, 08195
Hospital Clinico Universitario de Santiago
Santiago de Compostela, 15706
Hospital Universitario Virgen Macarena
Seville, 41009
Oftalvist IMED Burjassot
Valencia, Burjassot, 46100
Hospital Universitario Miguel Servet
Zaragoza, 50009
France8 sites
Groupe Hospitalier Pellegrin - CHU de Bordeaux
Bordeaux, 33076
Centre Hospitalier Intercommunal De Créteil
Créteil, 94000
CHU Dijon Bourgogne - Hôpital François Mitterrand
Dijon, 21079
Centre Ophtalmologique Pôle Vision Val d'Ouest
Écully
Centre Monticelli Paradis d'Ophtalmologie
Marseille
Centre Hospitalier Universitaire de Nice
Nice, 06001
Hôpital Lariboisière - Service d'ophtalmologie
Paris, 75010
Centre Ophtalmologique Maison Rouge
Strasbourg, 67000
Italy8 sites
Azienda Ospedaliera Universitaria Careggi
Florence, 50134
IRCCS MultiMedica
Milan, 20123
ASST Fatebenefratelli Sacco
Milan, 20157
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, 20122
IRCCS Ospedale San Raffaele
Milan, 20132
Fondazione G.B. Bietti Per Lo Sudio E La Ricerca In Oftalmologia - Presidio
Roma, 00184
Fondazione PTV Policlinico Tor Vergata
Rome, 00133
Fondazione Policlinico Agostino Gemelli
Rome, 00168
Australia5 sites
Eye Clinic Albury Wodonga
Albury, New South Wales, 2640
Marsden Eye Specialists
Parramatta, New South Wales, 2150
Strathfield Retina Clinic
Strathfield, New South Wales, 2135
Sydney Eye Hospital
Sydney, New South Wales, 2000
Sydney Retina Clinic and Day Surgery
Sydney, New South Wales, 2000
Germany5 sites
Universitäts-Klinikum Bonn
Bonn, 53127
Universitätsklinikum Heidelberg
Heidelberg, 69120
Augenzentrum am St. Franziskus-Hospital
Münster, North Rhine-Westphalia, 48145
Dietrich Bonhoeffer Klinikum Klinik für Augenheilkunde
Neubrandenburg, Mecklenburg-Vorpommern, 17036
Universitätsklinikum Tübingen, Department für Augenheilkunde
Tübingen, 72076
Hungary5 sites
Semmelweis Egyetem
Budapest, 1085
Budapesti Bajcsy-Zsilinszky Kórház és Rendelőintézet Szemészet Osztály
Budapest, 1106
Budapest Retina Associates
Budapest, 1133
Debreceni Egyetem Klinikai Kozpont Nagyerdei Campus
Debrecen, Hajdú-Bihar, 4032
Ganglion Medical Center
Pécs, Baranya, 7621
Poland5 sites
Oftalmika Sp.Zo.O.
Bydgoszcz, 85-631
Centrum Diagnostyki I Mikrochirurgii Oka Lens Sp. Z O.O.
Olsztyn, 10-424
Ośrodek Chirurgii Oka Prof. Zagórskiego Sp. Z o.o.
Rzeszów, 35-017
Caminomed Sp. Z O.O.
Tarnowskie Góry, 42-600
Warszawski Szpital Okulistyczny
Warsaw, 01-258
Canada4 sites
Calgary Retina Consultants
Calgary, Alberta, T2H 0C8
Alberta Retina Consultants
Edmonton, Alberta, T5H 0X5
Ivey Eye Institute
London, Ontario, N6A 4V2
Retina Centre of Ottawa
Ottawa, Ontario, K2B 7E9
Czechia3 sites
Fakultní nemocnice Královské Vinohrady
Prague, 100 34
Všeobecná fakultní nemocnice V Praze
Prague, 128 08
Axon Clinical, s.r.o. Ocni Klinika
Prague, 150 00
United Kingdom3 sites
Moorfields Eye Hospital NHS foundation Trust
Greater London, London, EC1V 2PD
King's College Hospital
London, SE5 9RS
The Retina Clinic London
London, W1G 9AX
Austria2 sites
Klinikum Klagenfurt am Wörthersee
Klagenfurt, 9020
Kepler Universitätsklinikum
Linz, 4020
New Zealand2 sites
Southern Eye Specialists
Christchurch, Canterbury, 8013
Capital Eye Specialists
Te Aro, Wellington Region, 6011
Netherlands1 site
Elisabeth Hospital (ETZ) - location TweeSteden ziekenhuis
Tilburg, 5042 AD
About this study
Official title: 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.
- Conditions
- Geographic Atrophy
- Being tested
- Vonaprument, Sham Administration
- Medical subject headings
- Geographic Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VonaprumentDrug
Also called ANX007
Form: solution for injection; Route of Administration: IVT injection
Sham AdministrationOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Vonaprument | Experimental | Participants will receive vonaprument IVT injections every month during the 24-month treatment period. Receives: Drug: Vonaprument |
| Sham Group | Sham comparator | Participants will receive Sham IVT injections every month during the 24-month treatment period. Receives: Other: Sham Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline through Month 15
Proportion of Participants Experiencing a BCVA ≥15-letter Loss from Baseline Through Month 24 as Assessed by the ETDRS Chart at Any Two Consecutive Visits
Measured: Baseline through Month 24
Secondary outcomes (3)
Time to Confirmed BCVA ≥15-letter Loss
Measured: Baseline to Month 15 and Baseline to Month 24
Proportion of Participants with Low-luminance BCVA (LLVA) ≥15-letter Loss
Measured: Baseline through Month 15 and Baseline through Month 24
Change from Baseline in Area of Total Loss of the Ellipsoid Zone (EZ) Layer
Measured: Baseline, Month 15 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start30 Jul 2024
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Geographic AtrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-masked
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 659 participants (actual)
Sponsor and investigators
- Lead sponsor
- Annexon, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Annexon, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06510816
- Sponsor's protocol ID
- ANX007-GA-02
- Other IDs
- 2024-515022-88-00
- Acronym
- ARCHER II
- Status last verified
- Oct 2026
- First submitted
- 15 Jul 2024
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06510816
- Acronym / sponsor ID
- ARCHER II / ANX007-GA-02
- Conditions
- Geographic Atrophy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 659 participants (actual)
- Lead sponsor
- Annexon, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Jul 2024 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 19 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-masked
| Arm | Type | Receives |
|---|---|---|
| Vonaprument | Experimental | Drug: VonaprumentParticipants will receive vonaprument IVT injections every month during the 24-month treatment period. |
| Sham Group | Sham comparator | Other: Sham AdministrationParticipants will receive Sham IVT injections every month during the 24-month treatment period. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of dry AMD with GA as determined by the Investigator and confirmed by the independent Central Reading Center.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VonaprumentAlso: ANX007Form: solution for injection; Route of Administration: IVT injection | Drug | Vonaprument |
| Sham AdministrationForm 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). | Other | Sham Group |
Primary outcome
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
Proportion of Participants Experiencing a BCVA ≥15-letter Loss from Baseline Through Month 24 as Assessed by the ETDRS Chart at Any Two Consecutive Visits
Time frame: Baseline through Month 24
3 secondary outcomes
Time to Confirmed BCVA ≥15-letter Loss
Time frame: Baseline to Month 15 and Baseline to Month 24
Proportion of Participants with Low-luminance BCVA (LLVA) ≥15-letter Loss
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Geographic Atrophy
Active, not recruitingPhase 1/2
Phase 1/2 Study of VOY-101 in Patients With Advanced Non-Neovascular Age-Related Macular Degeneration
Age-Related Macular Degeneration, Geographic Atrophy
RecruitingPhase 1/2
Autologous Transplantation of Induced Pluripotent Stem Cell-Derived Retinal Pigment Epithelium for Geographic Atrophy Associated With Age-Related Macular Degeneration
Dry Age-Related Macular Degeneration, Geographic Atrophy
RecruitingPhase 3
A Study Investigating Subcutaneously Administered Pozelimab in Combination With Cemdisiran or Cemdisiran Alone in Adult Participants With Geographic Atrophy
Age-related Macular Degeneration (AMD), Geographic Atrophy (GA)
RecruitingPhase 1
Phase 1 Study of C.001 in Retinal Degeneration
Geographic Atrophy, Stargardt Disease
RecruitingPhase 2/3
A Long-term Extension Study of JNJ-81201887 (AAVCAGsCD59) Parent Studies in Participants With Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD)
Geographic Atrophy, Macular Degeneration
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Annexon, Inc.
132 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vonaprument in people with Geographic Atrophy, run by Annexon, Inc. at 132 sites in 14 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 132 sites in United States, Spain, France, Italy, Australia and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.