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Gene Therapy Trial Browser
Clinical Trial Report
Gene Therapy Trial Report
Summary
Study to Evaluate Safety of RTx-015 Injection in Retinitis Pigmentosa or Choroideremia Patients (ENVISION)
NCTID
NCT06460844
(View at clinicaltrials.gov)
Description
A Phase 1, open-label, non-randomized, dose-escalation study, where approximately 15 eligible patients with retinitis pigmentosa or choroideremia will be enrolled sequentially in up to 3 dose cohorts of RTx-015. Enrolled patients will receive a single, unilateral intravitreal injection of RTx-015 in the study eye at Visit 3 (Day 0) and be followed for a total of 12 months.
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Development Status
Active
Indication
Retinitis Pigmentosa, Choroideremia
Disease Ontology Term
DOID:10584
Compound Name
RTx-015
Sponsor
Ray Therapeutics, Inc.
Funder Type
Industry
Recruitment Status
Recruiting
Enrollment Count
15
Results Posted
Not Available
Therapy Information
Target Gene/Variant
Codon optimized ChR-3M
Therapy Type
Gene transfer
Therapy Route
In-vivo
Mechanism of Action
Overexpression of protective allele/gene
Route of Administration
Intravitreal
Drug Product Type
Viral vector
Target Tissue/Cell
Delivery System
Viral transduction
Vector Type
AAV.7m8
Editor Type
none
Dose 1
Undisclosed low dose
Dose 2
Undisclosed medium dose
Dose 3
Undisclosed high dose
Dose 4
Dose 5
Study Record Dates
Current Stage
Phase1
Submit Date
2024-06-10
Completion Date
2026-05
Last Update
2025-03-10
Participation Criteria
Eligible Age
>=18 Years
Standard Ages
Adult, Older adult
Sexes Eligible for Study
ALL
Locations
No.of Trial Sites
3
Locations
United States
Regulatory Information
Has US IND
True
FDA Designations
Recent Updates
Resources/Links
News and Press Releases
About Ray Therapeutics
On a Personal Mission for His Daughter, Paul Bresge Launches Another Eye Disease Biotech With $100M for Ray Therapeutics
Preclinical Publications
AAV dose-dependent transduction efficiency in retinal ganglion cells and functional efficacy of optogenetic vision restoration
Improved CoChR Variants Restore Visual Acuity and Contrast Sensitivity in a Mouse Model of Blindness under Ambient Light Conditions