drugset / Trial / NCT07482176

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

NCT07482176

Phase 3 Recruiting 284 enrolled Adverum Biotechnologies, Inc.
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2026-03-16
Primary completion
2027-11-15
Completion
2031-10-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Aflibercept Protein / enzyme biologic 2 mg Intravitreal
Subject Ixo-vec Gene therapy (AAV / viral vector) 6e+10 vg Intravitreal