Clinical Trial: ATSN-201 Gene Therapy in RS1-Associated X-linked Retinoschisis
Study Status: RECRUITING
Recruit Status: RECRUITING
Study Type: INTERVENTIONAL
Official Title: A Phase 1/2, Open-Label, Dose Escalation and Dose Expansion Study to Evaluate the Safety and Tolerability of ATSN-201 Gene Therapy in Male Subjects With RS1-Associated X-linked Retinoschisis
Brief Summary: This study will evaluate the safety and tolerability of ATSN-201 in male subjects 6 to 64 years old with RS1-associated X-linked retinoschisis (XLRS).
Detailed Summary: Eligible patients who enroll in this study will receive a one-time subretinal injection of ATSN-201 in one eye.
Safety and tolerability will be evaluated for 5 years.
Sponsor: Atsena Therapeutics Inc.
Current Primary Outcome: Incidence of dose-limiting toxicities (DLTs) and treatment-emergent adverse events (TEAEs).
Original Primary Outcome: Incidence of dose-limiting toxicities (DLTs) and treatment-emergent adverse events (TEAEs).
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Atsena Therapeutics Inc.
Dates:
Date Received: May 12, 2023
Date Started: August 22, 2023
Date Completion: August 22, 2023
Last Updated: November 14, 2023
Last Verified: November 01, 2023