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

NCT07482176 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 284

Last updated 2026-05-20

No results posted yet for this study

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.

Conditions

  • Neovascular Age-Related Macular Degeneration (nAMD)
  • Wet AMD

Interventions

GENETIC

Ixo-vec

Ixo-vec will be administered intravitreally.

DRUG

Aflibercept

Aflibercept will be administered intravitreally.

Sponsors & Collaborators

  • Adverum Biotechnologies, Inc.

    lead INDUSTRY

Principal Investigators

  • Adam Turpcu, PhD · Adverum Biotechnologies, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-16
Primary Completion
2027-11-15
Completion
2031-10-20
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07482176 on ClinicalTrials.gov