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

NCT07502664 | Recruiting

• 1 other identifier: RTx-VRAI-NHS02 (DEFINE-IRD)
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Secondary Outcomes (2)

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

  2 years

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

  2 years

Study Arms (2)

Retinitis Pigmentosa

Up to 25 patients with Retinitis Pigmentosa

Other Retinal Dystrophies

Up to 25 patients with Other Retinal Dystrophies

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with moderate to profound vision impairment diagnosed with retinitis pigmentosa or other retinal dystrophies.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ray Therapeutics, Inc.: lead

Study Sites (1)

Vision Research and Assessment Institute

Irvine, California, 92614, United States

RECRUITING

MeSH Terms

Conditions

Retinitis Pigmentosa; Stargardt Disease; Retinoschisis; Retinal Dystrophies

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Retinal Degeneration; Retinal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Macular Degeneration

Central Study Contacts

Reem Jaber, MS, CGC

CONTACT

949-264-3793; info@vr-ai.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2026
• First Posted: March 31, 2026
• Study Start: February 19, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: March 31, 2026

Record last verified: 2026-03

Locations

US (1)