Study of Ixo-vec Gene Therapy Safety and Effectiveness in the Second Eye of Adults 50 and Older With Wet Age-Related Macular Degeneration

What this Trial Is About

Researchers are evaluating the safety, tolerability, and effectiveness of a gene therapy called Ixo-vec Ixoberogene soroparvovec in adults aged 50 years and older who have bilateral neovascular wet age-related macular degeneration nAMD. This Phase 2, single-arm, open-label study focuses on treating the second eye contralateral eye with Ixo-vec, including participants who have previously received the therapy in one eye and those receiving it for the first time. The study aims to understand how well the treatment works and how long its effects last when both eyes are treated at different times. Participants will receive a single intravitreal injection of Ixo-vec in the contralateral eye. The study includes both participants experienced with Ixo-vec and those who are treatment-nave, with dosing designed to evaluate safety and clinical activity including visual and anatomical outcomes. The treatments durability will be assessed over time, along with the need for additional anti-VEGF therapy. The study does not involve a placebo or comparator group and is conducted across multiple centers. During the study, participants will be followed for approximately 5 years to monitor safety, including ocular and non-ocular adverse events, and to evaluate visual acuity and retinal thickness changes. Researchers will also track supplemental aflibercept injections required after treatment. Participants will undergo regular assessments of vision and eye health, and adherence to study procedures will be monitored throughout. The long follow-up period allows evaluation of the gene therapys lasting effects and safety profile in bilateral treatment of nAMD.

Ixoberogene Soroparvovec (Ixo-vec) Contralateral Dosing Study in Participants With Neovascular Age-related Macular Degeneration