Geographic AtrophyPhase 3AiiM OLENCT07807969
An Open-label Extension Study of the Long-Term Safety of Vonaprument (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 7 sites in United States.
Trial summary
The primary purpose of the study is to assess the long term safety of intravitreal (IVT) injections of vonaprument. 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?
- No, everyone receives an active treatment
- How many people
- 605 participants
- Where
- 7 sitesUnited States
- Study dates
- 30 Sep 2026to 31 Jul 2029
- 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
- Participants with a diagnosis of dry AMD with GA who completed the Phase 3 ARCHER II study (NCT06510816) and who had not permanently ceased receiving the assigned masked treatment (IVT or Sham administration) at/before the ARCHER II Month 24 Visit.
Who cannot join
- Any event or condition arising during the ARCHER II study that would put the participant in danger or lead to undue harm by participating in this OLE study.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites
Asheville Eye Associates - Retina Division
Asheville, North Carolina, 28803
Verum Research, LLC
Eugene, Oregon, 97401
Cumberland Valley Retina Consultants
Hagerstown, Maryland, 21740
Mid Atlantic Retina Specialists
Hagerstown, Maryland, 21740
Retina Group of Florida
Sarasota, Florida, 34233
Retina Research Institute at New England Retina Consultants
Springfield, Massachusetts, 01107
Retina Vitreous Associates of Florida
St. Petersburg, Florida, 33711
About this study
Official title: A Multicenter, Open-Label Extension Study of the Long-Term Safety of Vonaprument (ANX007) Administered by Intravitreal Injection in Participants With Dry Age-Related Macular Degeneration With Geographic Atrophy
The primary purpose of the study is to assess the long term safety of intravitreal (IVT) injections of vonaprument.
- Conditions
- Geographic Atrophy
- Being tested
- Vonaprument
- 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
| Study group | Role | What they receive |
|---|---|---|
| Vonaprument | Experimental | Participants will receive vonaprument IVT injections every month for 24 months. Receives: Drug: Vonaprument |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Treatment Emergent Adverse Events
Measured: Through Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start30 Sep 2026 (estimated)
- Primary completion31 Jul 2029 (estimated)
- Study completion31 Jul 2029 (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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 605 participants (estimated)
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
- NCT07807969
- Sponsor's protocol ID
- ANX007-GA-03
- Other IDs
- 2026-527023-96-00
- Acronym
- AiiM OLE
- Status last verified
- Sep 2026
- First submitted
- 3 Sep 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label Extension Study of the Long-Term Safety of Vonaprument (ANX007) Administered by Intravitreal Injection in Participants With Dry Age-Related Macular Degeneration With Geographic Atrophy
- ClinicalTrials.gov ID
- NCT07807969
- Acronym / sponsor ID
- AiiM OLE / ANX007-GA-03
- Conditions
- Geographic Atrophy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 605 participants (estimated)
- Lead sponsor
- Annexon, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 31 Jul 2029 (estimated)
- Study completion
- 31 Jul 2029 (estimated)
- First posted
- 8 Sep 2026 (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 assess the long term safety of intravitreal (IVT) injections of vonaprument.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vonaprument | Experimental | Drug: VonaprumentParticipants will receive vonaprument IVT injections every month for 24 months. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants with a diagnosis of dry AMD with GA who completed the Phase 3 ARCHER II study (NCT06510816) and who had not permanently ceased receiving the assigned masked treatment (IVT or Sham administration) at/before the ARCHER II Month 24 Visit.
Key exclusion criteria (1 listed)
- Any event or condition arising during the ARCHER II study that would put the participant in danger or lead to undue harm by participating in this OLE study.
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 |
Primary outcome
Number of Participants with Treatment Emergent Adverse Events
Time frame: Through Month 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 8 Sep 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.
Clinical Trials study director
Annexon, Inc.
7 sites in 1 country: 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 7 sites in United States.
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 1 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: opening soon, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. 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. 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?
Contact Study Coordinator (650-822-5500, clinicaltrials@annexonbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Treatment Emergent Adverse Events (time frame: Through Month 24). 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 8 Sep 2026.