Clinical Trial

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

Study acronym: AQUARIUS
Recruiting Phase 3
View on ClinicalTrials.gov →
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 intravitreal aflibercept (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 as an average at Weeks 52 and 56. Safety, tolerability, and efficacy will be evaluated throughout the study.
Protocol Amendment History 4 changes
notable Trial sites expanded: 65 -> 79 locations 2026-07-16
notable Trial sites expanded: 46 -> 65 locations 2026-06-16
notable Trial sites expanded: 36 -> 46 locations 2026-05-21
notable Trial sites expanded: 2 -> 36 locations 2026-04-30
Trial Details
NCT Number NCT07482176
Lead Sponsor Adverum Biotechnologies, Inc.
Conditions Neovascular Age-Related Macular Degeneration (nAMD), Wet AMD
Enrollment 284 participants
Start Date 2026-03-16
Primary Completion 2027-11-15 (estimated)
Study Completion 2031-10-20 (estimated)
Updated on ClinicalTrials.gov 2026-07-15