RECRUITING

BS01 in Patients With Retinitis Pigmentosa

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

A Phase 1/2, Safety and Efficacy Trial of BS01, a Recombinant Adeno-Associated Virus Vector Expressing ChronosFP (AAV2-CAG-ChronosFP) in Patients with Retinitis Pigmentosa

Official Title

Phase 1/2, Safety and Efficacy Trial of BS01, a Recombinant Adeno-Associated Virus Vector Expressing ChronosFP in Patients With Retinitis Pigmentosa

Quick Facts

Study Start:2020-02-06
Study Completion:2029-12-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04278131

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:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Confirmed diagnosis of retinitis pigmentosa
  2. * At least one eye with vision no better than 20/160 visual acuity on the EDTRS scale or, for patients with peripheral vision loss, a visual field no greater than 30°.
  1. * Prior receipt of any AAV gene therapy product
  2. * Large amplitude nystagmus

Contacts and Locations

Study Contact

Minako Koga
CONTACT
mkoga@kmphc.com

Principal Investigator

Sheila Nirenberg, PhD
STUDY_DIRECTOR
Bionic Sight LLC

Study Locations (Sites)

New Jersey Retina
Teaneck, New Jersey, 07666
United States

Collaborators and Investigators

Sponsor: Bionic Sight LLC

  • Sheila Nirenberg, PhD, STUDY_DIRECTOR, Bionic Sight LLC

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 Date2020-02-06
Study Completion Date2029-12-30

Study Record Updates

Study Start Date2020-02-06
Study Completion Date2029-12-30

Terms related to this study

Additional Relevant MeSH Terms

  • Retinitis Pigmentosa