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

Annexon

Status and phase: Enrolling; Phase 3

Conditions: Geographic Atrophy

Treatments: Drug: ANX007; Other: Sham Administration

Study type: Interventional

Funder types: Industry

Identifiers

NCT06510816

ANX007-GA-02

Details and patient eligibility

About

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).

Enrollment: 630 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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630 participants in 2 patient groups

ANX007

Experimental group

Description:

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

Treatment:

Drug: ANX007

Sham Group

Sham Comparator group

Description:

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

Treatment:

Other: Sham Administration