Phase 2RecruitingAge-related condition
Ixoberogene Soroparvovec (Ixo-vec) Contralateral Dosing Study in Participants With Neovascular Age-related Macular Degeneration
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.
- Sponsor
- Adverum Biotechnologies, Inc. (Industry)
- Enrollment
- 15 planned
- Conditions
- Neovascular Age-Related Macular Degeneration (nAMD) Wet AMD
- Interventions
- Ixo-vec
- Ages
- adults, older adults
- Registry
- NCT07630649
Full record on ClinicalTrials.gov
From the registry
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…
Primary outcomes
- Incidence of ocular adverse events (AEs)
- Incidence of ocular serious adverse events (SAEs).
- Incidence of non-ocular serious adverse events (SAEs).
History
Primary completion expected
Last registry update
Registered
Started