Development and Evaluation of Functional Visual Field and Navigation Endpoints in Moderate to Profound Inherited Retinal Disease (DEFINE-IRD)

Ray Therapeutics, Inc.25 enrolled

Overview

The Vision Research and Assessment Institute (VRAI) was established with the 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. The VRAI facilitates the development and refinement of existing endpoints specifically for testing patients with Low Vision.

This observational, non-interventional study is designed to assess both the operational feasibility and the measurement properties of selected visual function assessments in this population. The study will emphasize outcome measures that are sensitive to peripheral visual function and that reflect real-world functional abilities, including spatial orientation, mobility, and wayfinding.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Retinitis Pigmentosa Stargardt Macular Dystrophy Stargardt Disease Geographic Atrophy From Age-related Macular Degeneration X-linked Retinoschisis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of bilateral retinitis pigmentosa (RP) or other retinal dystrophies impacting peripheral vision as confirmed from previous eye examination records * Best-corrected visual acuity between 20/200 to HM in at least one eye. * Reasonably fluent in English or Spanish Exclusion Criteria: * Cognitive impairment, memory loss or dementia sufficient in severity to preclude informed consent 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 * Current pregnancy as reported by patient

Outcomes

Primary Outcomes

Operational feasibility of testing moderate to profound vision impaired patients with various retinal dystrophies on a battery of visual assessments

Determining how many patients in the visual range 20/200 - HM (depending upon indication) can perform specific tests of visual function with a measurable score.

Time frame: 3 months

Secondary Outcomes

To quantify patient-based measurement properties of each test modality (for the purposes of endpoint qualification)

Test-rest reliability on the same visit or on two different testing sessions on different days including determination of significant learning effects of other scoring variables that impact variability.

Time frame: 2 years

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.