ANX007 for Age-Related Macular Degeneration

(ARCHER II Trial)

Recruiting at 131 trial locations

Overseen By Wayne Solley

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Annexon, Inc.

Disqualifiers: Stargardt disease, Cone-rod dystrophy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 24

Duration: 24 months

630 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

What is the purpose of this trial?

The primary purpose of the study is to determine if IVT injections of ANX007 every month reduce vision loss in participants with GA secondary to age-related macular degeneration (AMD).

Research Team

Clinical Trials

Principal Investigator

Annexon, Inc.

Eligibility Criteria

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.

Inclusion Criteria

I have been diagnosed with geographic atrophy in the macula due to AMD.

Exclusion Criteria

My vision loss is not due to AMD but another condition.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ANX007 or Sham IVT injections every month

24 months

24 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• ANX007

Trial Overview 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.

Participant Groups

Group I: ANX007 Experimental Treatment 1 Intervention

Participants will receive ANX007 IVT injections every month during the 24-month treatment period.

Group II: Sham Group Placebo Group 1 Intervention

Participants will receive Sham IVT injections every month during the 24-month treatment period.

Who Is Running the Clinical Trial?

Annexon, Inc.

Lead Sponsor

Trials

14

Recruited

1,500+