A Study Investigating the Efficacy and Safety of Intravitreal (IVT) Injections of ANX007 in Participants With Geographic Atrophy (GA)

Phase 3

Recruiting

• Conditions: Geographic Atrophy
• Interventions: Drug: ANX007; Other: Sham Administration

• Registration Number: NCT06510816
• Lead Sponsor: Annexon, Inc.

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-15
• Study First Submitted QC: 2024-07-15
• Study First Posted: 2024-07-19
• Study Start: 2024-07-30
• Status Verified: 2024-11
• Last Update Submitted: 2024-12-02
• Last Update Posted: 2024-12-04
• Primary Completion: 2026-10-31
• Study Completion: 2027-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 630

Inclusion Criteria

• Diagnosis of GA of the macula secondary to AMD as determined by the Investigator and confirmed by the independent Central Reading Center.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ANX007	ANX007	Participants will receive ANX007 IVT injections every month during the 24-month treatment period.
Sham Group	Sham Administration	Participants will receive Sham IVT injections every month during the 24-month treatment period.

Primary Outcome Measures

Name	Time	Method
Proportion of patients experiencing a best corrected visual acuity (BCVA) ≥15-letter loss from baseline through the primary timepoint as assessed by the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at any two consecutive visits.	The primary timepoint is based on accumulation of the target event rate, but no earlier than Month 12 and no later than Month 18

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in the Hazard of ≥15 letter BCVA Loss Through Month 12 and Month 24	Baseline, Months 12 and 24

Trial Locations

Locations (48)

Retina Consultants of Texas San Antonio; 🇺🇸 San Antonio, Texas, United States

Texas Retina Associates - Fort Worth; 🇺🇸 Fort Worth, Texas, United States

Retina Macula Institute of Arizona; 🇺🇸 Scottsdale, Arizona, United States

RCOC Clinical Research Institute Inc; 🇺🇸 Fullerton, California, United States

Retina Consultants Medical Group; 🇺🇸 Modesto, California, United States

Northern California Retina Vitreous Associates Medical Group, Inc.; 🇺🇸 Mountain View, California, United States

Georgia Retina PC; 🇺🇸 Marietta, Georgia, United States

Retina Associates - Elmhurst Location; 🇺🇸 Elmhurst, Illinois, United States

Retina Research Institute at New England Retina Consultants; 🇺🇸 Springfield, Massachusetts, United States

Retina Consultants of Minnesota; 🇺🇸 Saint Louis Park, Minnesota, United States

Vision Research Center Eye Associates of New Mexico; 🇺🇸 Albuquerque, New Mexico, United States

Long Island Vitreoretinal Consultants; 🇺🇸 Hauppauge, New York, United States

Eyehealth Northwest Portland; 🇺🇸 Portland, Oregon, United States

Charleston Neuroscience Center; 🇺🇸 Charleston, South Carolina, United States

Retina Research Institute of Texas; 🇺🇸 Abilene, Texas, United States

Southwest Retina Specialists; 🇺🇸 Amarillo, Texas, United States

Texas Retina Associates- Arlington; 🇺🇸 Arlington, Texas, United States

Retina Consultants of Texas; 🇺🇸 Schertz, Texas, United States

Strategic Clinical Research Group, LLC; 🇺🇸 Willow Park, Texas, United States

Piedmont Eye Center; 🇺🇸 Lynchburg, Virginia, United States

Retina-Vitreous Associates Medical Group; 🇺🇸 Beverly Hills, California, United States

Retina Consultants of San Diego; 🇺🇸 Poway, California, United States

Retinal Consultants Medical Group Inc; 🇺🇸 Sacramento, California, United States

Orange County Retina Medical Group; 🇺🇸 Santa Ana, California, United States

Bay Area Retina Associates Walnut Creek; 🇺🇸 Walnut Creek, California, United States

Florida Retina Institute- Jacksonville; 🇺🇸 Jacksonville, Florida, United States

Florida Retina Institute- Orlando; 🇺🇸 Orlando, Florida, United States

Fort Lauderdale Eye Institute; 🇺🇸 Plantation, Florida, United States

Retina Vitreous Associates of Florida; 🇺🇸 Saint Petersburg, Florida, United States

Retina Group of Florida - Sarasota Center; 🇺🇸 Sarasota, Florida, United States

Cumberland Valley Retina Consultants PC; 🇺🇸 Hagerstown, Maryland, United States

Mid Atlantic Retina Specialists - Hagerstown; 🇺🇸 Hagerstown, Maryland, United States

Ophthalmic Consultants of Boston; 🇺🇸 Boston, Massachusetts, United States

Sierra Eye Associates; 🇺🇸 Reno, Nevada, United States

Envision Ocular, LLC; 🇺🇸 Bloomfield, New Jersey, United States

Mid Atlantic Retina- New Jersey; 🇺🇸 Cherry Hill, New Jersey, United States

Asheville Eye Associates - Retina Division; 🇺🇸 Asheville, North Carolina, United States

Cleveland Clinic - Main Campus; 🇺🇸 Cleveland, Ohio, United States

Retina Vitreous Center - Edmond; 🇺🇸 Edmond, Oklahoma, United States

Verum Research, LLC; 🇺🇸 Eugene, Oregon, United States

Erie Retina Research; 🇺🇸 Erie, Pennsylvania, United States

Eye Care Specialists; 🇺🇸 Kingston, Pennsylvania, United States

Austin Retina Associates; 🇺🇸 Austin, Texas, United States

Austin Clinical Research, LLC; 🇺🇸 Austin, Texas, United States

Retina Consultants of Texas - Bellaire; 🇺🇸 Bellaire, Texas, United States

Retina Foundation of the Southwest; 🇺🇸 Dallas, Texas, United States

Texas Retina Associates - Plano; 🇺🇸 Dallas, Texas, United States

Retina Consultants of Texas - (The Woodlands); 🇺🇸 The Woodlands, Texas, United States