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

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

Recruiting
18 years and older
All
Phase N/A

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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.

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

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

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

NCT07502664

Ray Therapeutics, Inc.

13 May 2026

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