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)

A Phase 3, Multicenter, Randomized, Parallel-Group, Double-Masked, 2-Arm, Sham Controlled Study of the Efficacy, Safety, and Tolerability of ANX007 (Vonaprument) Administered by Intravitreal Injection in Participants With Dry Age-Related Macular Degeneration With Geographic Atrophy

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06510816

Acronym

ARCHER II

Enrollment

659

Registered

2024-07-19

Start date

2024-07-30

Completion date

2027-07-31

Last updated

2026-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Geographic Atrophy

Brief summary

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.

Interventions

DRUGVonaprument

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

OTHERSham Administration

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).

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

Double-masked

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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	Baseline through Month 15

Secondary

Measure	Time frame
Time to Confirmed BCVA ≥15-letter Loss	Baseline to Month 15 and Baseline to Month 24
Proportion of Participants Experiencing a Confirmed BCVA ≥15-letter Loss	Baseline through Month 24
Proportion of Participants with Low-luminance BCVA (LLVA) ≥15-letter Loss	Baseline through Month 15 and Baseline through Month 24
Change from Baseline in Area of Total Loss of the Ellipsoid Zone (EZ) Layer	Baseline, Month 15 and 24

Countries

Australia, Austria, Canada, Czechia, France, Germany, Hungary, Italy, Netherlands, New Zealand, Poland, Spain, United Kingdom, United States

Contacts

STUDY_DIRECTORClinical Trials

Annexon, Inc.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 5, 2026