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

Phase 3Active Not RecruitingNCT06510816

Annexon, Inc.659 enrolled

Overview

The primary purpose of the study is to determine if IVT injections of vonaprument every month reduce vision loss in participants with GA secondary to age-related macular degeneration (AMD).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

659

Conditions

Geographic Atrophy

Interventions

VonaprumentDRUG

Form: solution for injection; Route of Administration: IVT injection

Sham AdministrationOTHER

Form and Route of Administration: to mimic IVT injection (includes placement of the blunt opening of an empty, needleless syringe barrel on the conjunctiva in the inferotemporal quadrant of the eyeball to stimulate the pressure of an injection).

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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.

Locations (130)

Outcomes

Primary Outcomes

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.

Time frame: 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 Outcomes

Change From Baseline in the Hazard of ≥15 letter BCVA Loss Through Month 12 and Month 24

Time frame: Baseline, Months 12 and 24

Data from ClinicalTrials.gov

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