Observational Study to Assess Endpoint Operational Feasibility & Measurement Properties in Retinitis Pigmentosa Patients

Retinitis Pigmentosa Clinical Trial

Official title:

Observational, Non-Interventional Study to Determine the Operational Feasibility and Measurement Properties of Endpoints in Patients With Retinitis Pigmentosa

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06375239
• Other study ID #: RTx-VRAI-NHS01
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Retinitis
• Retinitis Pigmentosa

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