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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06375239
Other study ID # RTx-VRAI-NHS01
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 5, 2024
Est. completion date April 30, 2026

Study information

Verified date April 2024
Source Ray Therapeutics, Inc.
Contact Shawn Yu, OD
Phone 949-264-3793
Email info@vr-ai.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

RayTx established The Vision Research and Assessment Institute (VRAI) with the express purpose of serving as a testing facility for efficacy endpoints for patients with Low Vision. The mission of the VRAI is to enable the highest quality, standardized efficacy testing of patients with visual impairment to be performed by expert clinicians in an optimized environment. The proposed assessments or testing modalities to be evaluated in this non-interventional study are published in some capacity, and some of these publications already include patients with severe-to-profound vision loss from retinitis pigmentosa and other inherited retinal diseases.


Description:

The study is designed as a two-part, non-interventional prospective cohort study of up to 20-40 patients. In Part A, patients will be initially assessed on a battery of tests to determine operational feasibility. Between 5-10 patients are expected to complete Part A. Following Part A the battery of tests may be reduced or modified before proceeding to Part B. In Part B, the same patients from Part A and the remainder of the cohort (15-35 pts) will be scheduled for two visits separated by 1 day and up to 2 weeks. Part B will assess the variability of the battery of tests due to confounding variables such as disease progression. Additional visits over the course of one year from the first retest visit will be offered in order to better characterize the natural history decline and any impact to the battery of tests.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date April 30, 2026
Est. primary completion date April 30, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Diagnosis of bilateral retinitis pigmentosa confirmed from previous eye examination records - Best-corrected visual acuity between 20/200 and HM in at least one eye as tested with clinic-based visual acuity method - Reasonably fluent in English Exclusion Criteria: - Cognitive impairment, memory loss or dementia sufficient in severity to preclude informed or in the opinion of the investigator would prevent satisfactory completion of some or all of the testing. - Any circumstance that in the opinion of the investigator, would interfere with participation in, or compliance with the study protocol

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Vision Research and Assessment Institute Irvine California

Sponsors (2)

Lead Sponsor Collaborator
Ray Therapeutics, Inc. The Vision Research and Assessment Institute (VRAI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Operational feasibility of testing severe to profound vision impaired patients with RP on a battery of visual assessments Determining how many patients in the visual range 20/200 - HM can perform specific tests of visual function with a measurable score. 3 months
Secondary To quantify patient-based measurement properties of each test modality (for the purposes of endpoint qualification) Test-retest reliability on the same visit or on two different testing sessions on different days including determination of significant learning effects or other scoring variables that impact variability. 2 years
Secondary To quantify assessor-based measurement properties of each test modality (for the purposes of endpoint qualification) Intra- and inter-grader variability for scoring of tests by test graders/raters. Assessments incorporating independent graders/raters will be assessed for within session and across session scoring reliability to ensure consistent methods. 2 years
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