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
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.
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. ;
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