ANX007 for Age-Related Macular Degeneration

(ARCHER II Trial)

Not currently recruiting at 169 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether monthly injections of ANX007, an experimental treatment, can slow or stop vision loss in individuals with geographic atrophy (GA), a condition associated with age-related macular degeneration (AMD). Participants will receive either the ANX007 treatment or a placebo, a harmless substance with no treatment effect, for comparison. The trial is ideal for those diagnosed with GA specifically due to AMD, not other eye conditions. As a Phase 3 trial, it represents the final step before FDA approval, offering participants an opportunity to contribute to potentially groundbreaking treatment advancements.

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.

Is there any evidence suggesting that ANX007 is likely to be safe for humans?

Research has shown that ANX007 is generally well-tolerated. In earlier studies, patients who received monthly injections did not experience an increase in abnormal blood vessel growth in the eye compared to those who received placebo treatments. Both single and repeated injections were well-tolerated for up to 12 months, and the drug effectively reached and acted on the intended part of the eye without causing major problems. While these results are encouraging, ongoing research aims to confirm the treatment's safety and effectiveness. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for AMD?

ANX007 is unique because it targets a specific part of the immune system known as the complement system, which plays a role in inflammation and cell damage in age-related macular degeneration (AMD). Unlike standard treatments like anti-VEGF therapies, which focus on reducing blood vessel growth, ANX007 aims to protect retinal cells from degeneration by inhibiting complement activation. Researchers are excited about ANX007 because it offers a new approach to potentially preserving vision and addressing the underlying causes of AMD, rather than just managing symptoms.

What evidence suggests that ANX007 might be an effective treatment for age-related macular degeneration?

Research shows that ANX007, which participants in this trial may receive, might help protect vision in people with Geographic Atrophy (GA) caused by age-related macular degeneration (AMD). In earlier studies, ANX007 significantly helped maintain vision by protecting the central cells in the eye essential for clear sight. The treatment improved vision in key ways, such as enhancing clarity with glasses or contacts. These results suggest that ANX007 could slow vision loss in people with this condition. ^{2 5 6 7 8}

Who Is on the Research Team?

Clinical Trials

Principal Investigator

Annexon, Inc.

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Vonaprument Experimental Treatment 1 Intervention

Participants will receive vonaprument 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+

Citations

1. ir.annexonbio.com ir.annexonbio.com/news-releases/news-release-details/annexon-presents-phase-2-vision-preservation-data-anx007-dry-amd

Annexon Presents Phase 2 Vision Preservation Data with ... ANX007 demonstrated enhanced protection of vision and greater preservation of central photoreceptor cells in a subpopulation of patients with less advanced ...

2. ir.annexonbio.com ir.annexonbio.com/news-releases/news-release-details/annexon-announces-completion-enrollment-pivotal-phase-3-archer

Annexon Announces Completion of Enrollment in Pivotal ... Annexon Announces Completion of Enrollment in Pivotal Phase 3 ARCHER II Trial of Vonaprument (formerly ANX007) for Dry Age-Related Macular ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06510816

NCT06510816 | A Study Investigating the Efficacy and ... 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 ...

4. clinicaltrials.eu clinicaltrials.eu/trial/study-on-the-effectiveness-and-safety-of-anx007-injections-for-patients-with-geographic-atrophy-from-age-related-macular-degeneration/

Study on the Effectiveness and Safety of ANX007 Injections ... This clinical trial investigates the effectiveness and safety of ANX007 injections for treating Geographic Atrophy, a form of Age-Related Macular ...

5. ir.annexonbio.com ir.annexonbio.com/news-releases/news-release-details/annexon-present-neuroprotective-effects-anx007-2025-arvo-annual

Annexon to Present on the Neuroprotective Effects of ANX007 ... ANX007 is the only investigational therapy in GA to show significant vision preservation on the endpoints of best corrected visual acuity (BCVA) and low ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06510816

NCT06510816 | A Study Investigating the Efficacy and ... 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 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10130689/

Safety and Target Engagement of Complement C1q ... In these studies, single and repeat IVT ANX007 injections were well tolerated and demonstrated full target engagement 4 weeks after dosing with both low and ...

8. aao.org aao.org/newsroom/news-releases/detail/promising-new-drug-may-be-first-to-protect-vision

Promising New Drug May Be the First to Protect Vision in ... Patients treated monthly with an investigational drug (ANX007) cut their risk of vision loss by 72 percent.