RecruitingPhase 3NCT05878860

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

A Phase 1/2/3, Open-Label, Dose Escalation, Dose Expansion and Randomized, Controlled Study to Evaluate the Safety and Efficacy of ATSN-201 Gene Therapy in Subjects With RS1-Associated X-linked Retinoschisis (LIGHTHOUSE)

Sponsor

Atsena Therapeutics Inc.

Enrollment

97 participants

Start Date

Aug 22, 2023

Study Type

INTERVENTIONAL

Conditions

X-linked Retinoschisis

Summary

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

Eligibility

Min Age: 6 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called ATSN-201 for people with x-linked retinoschisis. The study is currently recruiting participants at 4 locations. People eligible for this study include aged 6 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALATSN-201

AAV.SPR-hGRK1-hRS1syn

Locations(21)

Associated Retina Consultants

Phoenix, Arizona, United States

Shiley Eye Institute

La Jolla, California, United States

Children's Hospital of Los Angeles

Los Angeles, California, United States

Stanford University

Palo Alto, California, United States

UC San Francisco

San Francisco, California, United States

Bascom Palmer Eye Institute

Miami, Florida, United States

Massachusetts Eye and Ear

Boston, Massachusetts, United States

Boston Children's Hospital

Boston, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Mayo Clinic

Rochester, Minnesota, United States

Columbia University

New York, New York, United States

Flaum Eye Institute, University of Rochester

Rochester, New York, United States

Duke University

Durham, North Carolina, United States

Oregon Health Sciences University

Portland, Oregon, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Retina Foundation of the Southwest

Dallas, Texas, United States

Moran Eye Center

Salt Lake City, Utah, United States

University of Wisconsin

Madison, Wisconsin, United States

The Hospital for Sick Children

Toronto, Ontario, Canada

McGill University (MUHC)

Montreal, Quebec, Canada

Oxford Eye Hospital

Oxford, England, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05878860

Related Trials

Development and Evaluation of Functional Visual Field and Navigation Endpoints in Moderate to Profound Inherited Retinal Disease (DEFINE-IRD)

NCT075026641 location

Safety and Efficacy of a Single Subretinal Injection of JWK002 Gene Therapy in Subjects With X-linked Retinoschisis(XLRS)

NCT063458981 location

Safety and Efficacy Study of LX103 Treatment of X-Linked Retinoschisis (XLRS)

NCT058149521 location