A Study Investigating the Efficacy and Safety of Intravitreal (IVT) Injections of Vonaprument (Formerly ANX007) in Participants With Dry Age-Related Macular Degeneration (AMD) 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 dry AMD with GA.

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 dry AMD with GA 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 apply.

Locations (132)

Outcomes

Primary Outcomes

Proportion of Participants Experiencing a Best Corrected Visual Acuity (BCVA) ≥15-letter Loss from Baseline Through Month 15 as Assessed by the Early Treatment Diabetic Retinopathy Study (ETDRS) Chart at Any Two Consecutive Visits

Time frame: Baseline through Month 15

Secondary Outcomes

Time to Confirmed BCVA ≥15-letter Loss

Time frame: Baseline to Month 15 and Baseline to Month 24

Proportion of Participants Experiencing a Confirmed BCVA ≥15-letter Loss

Time frame: Baseline through Month 24

Proportion of Participants with Low-luminance BCVA (LLVA) ≥15-letter Loss

Time frame: Baseline through Month 15 and Baseline through Month 24

Change from Baseline in Area of Total Loss of the Ellipsoid Zone (EZ) Layer

Time frame: Baseline, Month 15 and 24

Data from ClinicalTrials.gov

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