Investigating ANX007 injections for vision loss in geographic atrophy
A Phase 3, Multicenter, Randomized, Parallel-Group, Double-Masked, 2-Arm, Sham Controlled Study of the Efficacy, Safety, and Tolerability of ANX007 Administered by Intravitreal Injection in Patients With Geographic Atrophy (GA) Secondary to Age Related Macular Degeneration (AMD)
This study is testing if monthly injections of a new treatment called ANX007 can help people with vision loss from geographic atrophy due to age-related macular degeneration.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 630 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | Annexon, Inc. Industry-sponsored |
| Locations | 117 sites (Scottsdale, Arizona and 116 other locations) |
| Trial ID | NCT06510816 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the efficacy and safety of monthly intravitreal injections of ANX007 in patients suffering from geographic atrophy (GA) due to age-related macular degeneration (AMD). Participants will receive either the active treatment or a sham administration to assess the impact on vision loss. The study is designed to determine if ANX007 can effectively slow down the progression of vision impairment associated with GA. The trial is conducted in multiple locations across California and Arizona.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with geographic atrophy secondary to age-related macular degeneration.
Not a fit: Patients with geographic atrophy caused by conditions other than age-related macular degeneration will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce vision loss for patients with geographic atrophy.
How similar studies have performed: Other studies have shown promise with similar approaches, but the specific efficacy of ANX007 in this context is being investigated for the first time.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of GA of the macula secondary to AMD as determined by the Investigator and confirmed by the independent Central Reading Center. Exclusion Criteria: * 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. NOTE: Other protocol-defined inclusion and exclusion criteria may apply.
Where this trial is running
Scottsdale, Arizona and 116 other locations
- Retina Macula Institute of Arizona — Scottsdale, Arizona, United States (Recruiting)
- Retina-Vitreous Associates Medical Group — Beverly Hills, California, United States (Recruiting)
- RCOC Clinical Research Institute Inc — Fullerton, California, United States (Recruiting)
- Global Research Management — Glendale, California, United States (Recruiting)
- Retina Consultants Medical Group — Modesto, California, United States (Recruiting)
- Northern California Retina Vitreous Associates Medical Group, Inc. — Mountain View, California, United States (Recruiting)
- Retina Consultants of San Diego — Poway, California, United States (Completed)
- Retinal Consultants Medical Group — Sacramento, California, United States (Recruiting)
- California Retina Consultants- Santa Barbara — Santa Barbara, California, United States (Completed)
- Macula Retina Vitreous Research Institute — Torrance, California, United States (Recruiting)
- Bay Area Retina Associates — Walnut Creek, California, United States (Recruiting)
- Retina Consultants of Southern Colorado PC — Colorado Springs, Colorado, United States (Recruiting)
- RSC Research, LLC — Denver, Colorado, United States (Recruiting)
- Retina Consultants, P.C. — Manchester, Connecticut, United States (Completed)
- Rand Eye Institute — Deerfield Beach, Florida, United States (Recruiting)
- National Ophthalmic Research Institute — Fort Myers, Florida, United States (Recruiting)
- Florida Retina Institute- Jacksonville — Jacksonville, Florida, United States (Completed)
- Florida Retina Institute — Orlando, Florida, United States (Recruiting)
- Fort Lauderdale Eye Institute — Plantation, Florida, United States (Recruiting)
- Retina Vitreous Associates of Florida — Saint Petersburg, Florida, United States (Recruiting)
- Retina Group of Florida — Sarasota, Florida, United States (Recruiting)
- East Florida Eye Institute — Stuart, Florida, United States (Recruiting)
- Southern Vitreoretinal Associates — Tallahassee, Florida, United States (Recruiting)
- Georgia Retina PC — Marietta, Georgia, United States (Recruiting)
- Retina Consultants of Hawaii — 'Aiea, Hawaii, United States (Recruiting)
- Retina Associates - Elmhurst Location — Elmhurst, Illinois, United States (Recruiting)
- Illinois Retina Associates, S.C. — Oak Park, Illinois, United States (Completed)
- Springfield Clinic LLP — Springfield, Illinois, United States (Recruiting)
- Wolfe Eye Clinic — West Des Moines, Iowa, United States (Recruiting)
- Retina Associates of Kentucky — Lexington, Kentucky, United States (Not_yet_recruiting)
- Maine Eye Center — Portland, Maine, United States (Recruiting)
- Retina Group of Washington — Chevy Chase, Maryland, United States (Recruiting)
- Cumberland Valley Retina Consultants — Hagerstown, Maryland, United States (Recruiting)
- Mid Atlantic Retina Specialists — Hagerstown, Maryland, United States (Recruiting)
- Ophthalmic Consultants of Boston — Boston, Massachusetts, United States (Recruiting)
- Retina Research Institute at New England Retina Consultants — Springfield, Massachusetts, United States (Recruiting)
- Retina Consultants of Minnesota — Saint Louis Park, Minnesota, United States (Recruiting)
- Sierra Eye Associates — Reno, Nevada, United States (Recruiting)
- Envision Ocular, LLC — Bloomfield, New Jersey, United States (Recruiting)
- Mid Atlantic Retina — Cherry Hill, New Jersey, United States (Recruiting)
- Vision Research Center Eye Associates of New Mexico — Albuquerque, New Mexico, United States (Recruiting)
- Long Island Vitreoretinal Consultants — Hauppauge, New York, United States (Recruiting)
- Vitreous Retina Macula Consultants of NY (VRMNY) — New York, New York, United States (Completed)
- Asheville Eye Associates - Retina Division — Asheville, North Carolina, United States (Recruiting)
- North Carolina Retina Associates — Wake Forest, North Carolina, United States (Recruiting)
- Piedmont Retina Specialists - Winston Salem Office — Winston-Salem, North Carolina, United States (Recruiting)
- University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States (Recruiting)
- Cleveland Clinic Foundation — Cleveland, Ohio, United States (Not_yet_recruiting)
- Retina Vitreous Center — Edmond, Oklahoma, United States (Recruiting)
- Tulsa Retina Consultants — Tulsa, Oklahoma, United States (Recruiting)
+67 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Study Coordinator
- Email: clinicaltrials@annexonbio.com
- Phone: 650-822-5500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.