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) (AiiM OLE)

September 3, 2026 updated by: Annexon, Inc.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

605

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 Contact

Study Locations

  • United States
    • Florida
      • Sarasota, Florida, United States, 34233
        • Retina Group of Florida
      • St. Petersburg, Florida, United States, 33711
        • Retina Vitreous Associates of Florida
    • Maryland
      • Hagerstown, Maryland, United States, 21740
        • Cumberland Valley Retina Consultants
      • Hagerstown, Maryland, United States, 21740
        • Mid Atlantic Retina Specialists
    • Massachusetts
      • Springfield, Massachusetts, United States, 01107
        • Retina Research Institute at New England Retina Consultants
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Asheville Eye Associates - Retina Division
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Verum Research, LLC

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:

  • 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.

Exclusion Criteria:

  • 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.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vonaprument
Participants will receive vonaprument IVT injections every month for 24 months.
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
Number of Participants with Treatment Emergent Adverse Events
Time Frame: Through Month 24
Through Month 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 (Estimated)

September 30, 2026

Primary Completion (Estimated)

July 31, 2029

Study Completion (Estimated)

July 31, 2029

Study Registration Dates

First Submitted

September 3, 2026

First Submitted That Met QC Criteria

September 3, 2026

First Posted (Actual)

September 8, 2026

Study Record Updates

Last Update Posted (Actual)

September 8, 2026

Last Update Submitted That Met QC Criteria

September 3, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANX007-GA-03
  • 2026-527023-96-00 (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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