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

Study acronym: AQUARIUS
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Enrollment increased: 284 → 534 participants
    • Eligibility criteria expanded, about 33 words
    • Secondary endpoints: details revised at 7 of 26 entries
    • Study description revised
  2. Trial sites expanded: 65 → 79 locationsv5
  3. Trial sites expanded: 46 → 65 locationsv4
  4. Trial sites expanded: 36 → 46 locationsv3
  5. Trial sites expanded: 2 → 36 locationsv2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07482176
Lead Sponsor Adverum Biotechnologies, Inc.
Conditions
(from sponsor)		 Neovascular Age-Related Macular Degeneration (nAMD), Wet AMD
Related terms Blindness, Eye Diseases
Enrollment 534 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov