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Ixoberogene Soroparvovec (Ixo-vec) Contralateral Dosing Study in Participants With Neovascular Age-related Macular Degeneration
Sponsor: Adverum Biotechnologies, Inc.
Summary
The purpose of this study is to evaluate safety, effectiveness and durability of a gene therapy called Ixo-vec (Ixoberogene soroparvovec) when administered to the contralateral (second) eye of adult participants (≥ 50 years of age) who have been diagnosed with bilateral neovascular (wet) age related macular degeneration (nAMD). The study will enroll adults with nAMD in both eyes, including participants who previously received Ixo-vec treatment in one (initial) eye and/or participants who will receive Ixo-vec treatment for the first time. This study focuses on how the treatment works when both eyes are treated at different times and how effective and long-lasting Ixo-vec treatment is in the second (contralateral) eye. Participants will receive a single administration of Ixo-vec in the contralateral eye and will be followed for approximately 5 years to evaluate safety, efficacy and durability of contralateral treatment. Secondary objectives include assessments that will evaluate clinical activity, including visual and anatomic outcomes, as well as the need for supplemental anti-VEGF therapy. The study is intended to provide additional information on the safety, tolerability, and use of Ixo-vec in bilateral treatment.
Official title: Evaluation of the Safety and Tolerability of Ixoberogene Soroparvovec (Ixo-vec) Intravitreal Gene Therapy in the Second (Contralateral) Eye of Participants With Bilateral Neovascular Age-related Macular Degeneration.
Key Details
Gender
All
Age Range
50 Years - Any
Study Type
INTERVENTIONAL
Enrollment
15
Start Date
2026-06-02
Completion Date
2031-06
Last Updated
2026-06-05
Healthy Volunteers
No
Interventions
Ixo-vec
Ixo-vec (6 × 10\^10 vg/eye) will be administered intravitreally
Locations (4)
Adverum site 124
Deerfield Beach, Florida, United States
Adverum site 176
Fort Lauderdale, Florida, United States
Adverum site 168
Jacksonville, Florida, United States
Adverum site 122
West Columbia, South Carolina, United States