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NCT Number: NCT07502664

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vision Research and Assessment Institute

Irvine, California, 92614, United States

Location status: Recruiting

Location contact

Reem Jaber, MS, CGC

CONTACT

[email protected]

949-264-3793

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: 3 months

    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.

Secondary outcomes

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

    Time frame: 2 years

    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.

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

    Time frame: 2 years

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Reem Jaber, MS, CGC

CONTACT

[email protected]

949-264-3793

Sponsors and collaborators

Lead sponsor

Ray Therapeutics, Inc.

Industry

Registry information

Acronym: DEFINE-IRD

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 31, 2026
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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