RECRUITING

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

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Conditions

X-linked RetinoschisisXLRS, RS1

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

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

Quick Facts

Study Start:2023-08-22
Study Completion:2029-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05878860

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age ≥ 18 for Cohorts 1 through 3, and age ≥ 6 years and \< 18 years for Cohort 4.
  2. 2. Male patients with clinical diagnosis of XLRS caused by mutations in RS1.
  3. 3. Best corrected visual acuity (BCVA) in study eye of 34 to 73 Early Treatment Diabetic Retinopathy Study (ETDRS) letters (corresponding to a Snellen acuity of 20/200 to 20/40).
  1. 1. Pre-existing eye conditions in the study eye that would contribute significantly to an increased risk of visual loss from a subretinal injection.
  2. 2. Any intraocular surgery (including laser treatment) in the study eye within 6 months prior or any intraocular surgery anticipated in the study eye during the first 12 months of the study.
  3. 3. Treatment in a prior ocular gene or cell therapy study.

Contacts and Locations

Study Contact

Atsena Therapeutics Clinical Trials
CONTACT
984-261-2001
clinicaltrials@atsenatx.com

Study Locations (Sites)

Children's Hospital of Los Angeles
Los Angeles, California, 90027
United States
Bascom Palmer Eye Institute
Miami, Florida, 33136
United States
Oregon Health Sciences University
Portland, Oregon, 97239
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
United States

Collaborators and Investigators

Sponsor: Atsena Therapeutics Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-22
Study Completion Date2029-10

Study Record Updates

Study Start Date2023-08-22
Study Completion Date2029-10

Terms related to this study

Keywords Provided by Researchers

  • XLRS, RS1

Additional Relevant MeSH Terms

  • X-linked Retinoschisis