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Monoclonal Antibodies

ANX007 for Age-Related Macular Degeneration (ARCHER II Trial)

Phase 3
Recruiting
Research Sponsored by Annexon, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of GA of the macula secondary to AMD as determined by the Investigator and confirmed by the independent Central Reading Center.
Be older than 18 years old
Must not have
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Pivotal Trial

Summary

This trial aims to find out if monthly injections of ANX007 can help lessen vision loss in people with geographic atrophy (GA) caused by age-related macular degeneration (AMD).

Who is the study for?
This trial is for individuals with Geographic Atrophy (GA), a form of age-related macular degeneration that leads to vision loss. Participants should not have other eye conditions that could interfere with the study or be taking treatments that affect the immune system.
What is being tested?
The study tests if monthly eye injections of ANX007 can slow down vision loss in people with GA compared to sham (fake) injections. It's designed to see if this new treatment is effective and safe.
What are the potential side effects?
Potential side effects from IVT injections like ANX007 may include discomfort at the injection site, increased eye pressure, inflammation inside the eye, and possible visual disturbances.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with geographic atrophy in the macula due to AMD.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My vision loss is not due to AMD but another condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ANX007Experimental Treatment1 Intervention
Participants will receive ANX007 IVT injections every month during the 24-month treatment period.
Group II: Sham GroupPlacebo Group1 Intervention
Participants will receive Sham IVT injections every month during the 24-month treatment period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ANX007
2021
Completed Phase 2
~280

Find a Location

Who is running the clinical trial?

Annexon, Inc.Lead Sponsor
13 Previous Clinical Trials
849 Total Patients Enrolled
Clinical TrialsStudy DirectorAnnexon, Inc.
2,227 Previous Clinical Trials
895,792 Total Patients Enrolled
34 Trials studying Macular Degeneration
18,853 Patients Enrolled for Macular Degeneration
~420 spots leftby Oct 2026
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