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NCT Number: NCT06510816

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)

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Geographic Atrophy Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Eye Clinic Albury Wodonga, Albury, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vonaprument

Drug

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

Other names: ANX007

Sham Administration

Other

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).

Primary outcomes

  1. 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

  1. Time to Confirmed BCVA ≥15-letter Loss

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

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

    Time frame: Baseline through Month 24

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

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

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

    Time frame: Baseline, Month 15 and 24

Sponsors and collaborators

Lead sponsor

Annexon, Inc.

Industry

Registry information

Official study title

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

Acronym: ARCHER II

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jul 19, 2024
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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