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Neovascular Age-Related Macular Degeneration (nAMD)GeneticsVision and hearingGeneticDrugPhase 3

What this study is

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.

What's being tested

  • Ixo-vec

    Intervention · GENETIC

    Ixo-vec will be administered intravitreally.

  • Aflibercept

    Intervention · DRUG

    Aflibercept will be administered intravitreally.

Study details

Official title
A Multi-center, Randomized, Double-masked, Active-comparator-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Ixoberogene Soroparvovec (Ixo-vec) in Participants With Neovascular Age-related Macular Degeneration (AQUARIUS)
Sponsor
Adverum Biotechnologies, Inc.
Conditions
Neovascular Age-Related Macular Degeneration (nAMD) · Wet AMD
Enrolling
534 people
Starts
2026-03-16
Est. completion
2031-10-20
Design
Double-blind, randomized, parallel groups, Phase 3
Record
View on ClinicalTrials.gov ↗