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: 2025-05
• Last Update Submitted: 2025-05-08
• Last Update Posted: 2025-05-11
• 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.

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.

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 (114)

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

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

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

Global Research Management; 🇺🇸 Glendale, California, United States

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

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

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

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

California Retina Consultants- Santa Barbara; 🇺🇸 Santa Barbara, California, United States

Macula Retina Vitreous Research Institute; 🇺🇸 Torrance, California, United States

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