Vista - Phase 2/3 Currently Enrolling
The Vista clinical trial is a Phase 2/3 study to further assess the safety and effectiveness effect of AGTC-501 gene therapy and to determine whether it may help a person with XLRP see better or maintain current vision. Vista will enroll male patients with a confirmed diagnosis of X-Linked Retinitis Pigmentosa. Enrollment is expected to begin later this year.
Dawn - Phase 2 Open-label ENROLLING BY INVITATION
The Dawn clinical trial is a non-randomized, open-label study of AGTC-501 in participants with XLRP who have previously been treated with a full-length AAV-vector based gene therapy targeting RPGR protein. The purpose of Dawn is to assess 2 different doses of the study drug for efficacy, safety, and tolerability in a participant’s eye that was not previously treated (fellow eye) for XLRP.
SKYLINE - Phase 2 Expansion ENROLLMENT COMPLETE
The Skyline clinical trial is the Phase 2 follow-on study for male patients ages 8-50 years (inclusive) that completed in 2022. which 14 male participants received one of two dose levels of AGTC-501 in one eye to assess whether two doses of AGTC-501 demonstrate improvement in a participant’s vision and other symptoms of XLRP. Patients that met eligibility criteria and enrolled into the SKYLINE trial received a single injection of either a low dose or a high dose of AGTC-501 into one eye. An efficacious dose is evident. AGTC-501 is generally safe and well tolerated.
Click here to read about our promising 12-month data.
Horizon - Phase 1/2 ENROLLMENT COMPLETE
The Horizon clinical trial is a Phase 1/2 study that completed enrollment of 29 male participants and all participants are in long-term follow-up. Participants received a single dose of AGTC-501 in one eye to obtain initial data about safety and potential efficacy of AGTC-501 gene therapy. The 12-month post treatment data results demonstrate AGTC-501 is generally safe and well tolerated.
