NCT07502664Recruiting

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

Ray Therapeutics, Inc.

Start Date

2/19/2026

Completion Date

2/1/2027

Summary

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.

Detailed Description

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

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Conditions

Retinitis PigmentosaStargardt Macular DystrophyStargardt DiseaseGeographic Atrophy From Age-related Macular DegenerationX-linked RetinoschisisRetinal Dystrophies

Locations

Vision Research and Assessment Institute

Irvine, California 92614

United States