Clinical Trial

Efficacy and Safety Study of Ixoberogene Soroparvovec (Ixo-vec) in Participants With Neovascular Age-Related Macular Degeneration

Study acronym: ARTEMIS
Active, Not Recruiting Phase 3
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Summary
This is a multi-center, randomized, double-masked, active-comparator-controlled, Phase 3 study in a broad participant population (treatment-naïve and treatment-experienced) with neovascular (wet) age-related macular degeneration (nAMD). The study will evaluate a single intravitreal (IVT) injection of Ixo-vec compared to an active comparator. The primary endpoint of this study is the mean change in best corrected visual acuity (BCVA) of Ixo-vec compared to an active comparator measured at an average of Weeks 52 and 56. Safety, tolerability, and efficacy will be evaluated throughout the study.
Protocol Amendment History 10 amendments
This ClinicalTrials.gov record has been amended 10 times since 2025-02-26; most recent amendment 2026-05-20.
Status change: Recruiting → Active, Not Recruiting 2026-05-20
Status change: Not Yet Recruiting → Recruiting 2025-03-25
Trial Details
NCT Number NCT06856577
Lead Sponsor Adverum Biotechnologies, Inc.
Conditions Neovascular Age-Related Macular Degeneration (nAMD), Wet AMD
Enrollment 311 participants
Start Date 2025-02-28
Primary Completion 2026-12-22 (estimated)
Study Completion 2030-11-23 (estimated)
Updated on ClinicalTrials.gov 2026-05-22