ATSN-201 Gene Therapy in RS1-Associated X-linked Retinoschisis — LIGHTHOUSE

X-linked Retinoschisis Clinical Trial

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

Status Recruiting

Clinical Trial Summary

This study will evaluate the safety and tolerability of ATSN-201 in male subjects ≥ 6 years of age with RS1-associated X-linked retinoschisis (XLRS).

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05878860
Study type	Interventional
Source	Atsena Therapeutics Inc.
Contact	Atsena Therapeutics Clinical Trials
Phone	984-261-2001
Email	clinicaltrials@atsenatx.com
Status	Recruiting
Phase	Phase 1/Phase 2
Start date	August 22, 2023
Completion date	October 2029

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT06066008` - Safety and Efficacy Study of Novel Gene Therapy ZM-01 for X-linked Retinoschisis Patients	Early Phase 1
Completed	`NCT02331173` - Clinical Evaluation of Patients With X-linked Retinoschisis	N/A
Completed	`NCT02416622` - Safety and Efficacy of rAAV-hRS1 in Patients With X-linked Retinoschisis (XLRS)	Phase 1/Phase 2
Recruiting	`NCT05814952` - Safety and Efficacy Study of LX103 Treatment of X-Linked Retinoschisis (XLRS)	N/A