Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06375239
Status:
RECRUITING
Last Update Posted:
2024-04-19
First Post:
2024-04-15
Brief Title:
Observational Study to Assess Endpoint Operational Feasibility Measurement Properties in Retinitis Pigmentosa Patients
Sponsor:
Ray Therapeutics Inc
Organization:
Ray Therapeutics Inc
Study Overview
Official Title:
Observational Non-Interventional Study to Determine the Operational Feasibility and Measurement Properties of Endpoints in Patients With Retinitis Pigmentosa
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None