Recruiting

Observational Study

Sponsor:

Ray Therapeutics, Inc.

Code:

NCT06375239

Conditions

Retinitis Pigmentosa

Choroideremia

Stargardt Macular Dystrophy

Stargardt Disease

Geographic Atrophy from Age-related Macular Degeneration

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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

Choroideremia

Stargardt Macular Dystrophy

Stargardt Disease

Geographic Atrophy from Age-related Macular Degeneration

Study ID

NCT06375239

Start date

Apr 5, 2024

Status verified date

Jan, 2025

Completion date

Apr 30, 2026

Anticipated

Primary completion date

Apr 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Diagnosis of bilateral retinitis pigmentosa, choroideremia, Stargardt macular dystrophy, geographic atrophy from age-related macular degeneration, X-linked retinoschisis or other retinal dystrophies confirmed from previous eye examination records
  • Best-corrected visual acuity between 20/70 and HM in at least one eye as tested with clinic-based visual acuity method
  • Reasonably fluent in English

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 Design

Enrollment

120 participants

Anticipated

Interventions and Outcome Measures

Arms

Retinitis Pigmentosa

Up to 40 patients with Retinitis Pigmentosa

Choroideremia

Up to 40 patients with Choroideremia

Stargardt Macular Dystrophy (Stargardt Disease)

Up to 40 patients with Stargardt Macular Dystrophy also known as Stargardt Disease

Geographic Atrophy from Age-related Macular Degeneration

Up to 40 patients with Geographic Atrophy from Age-related Macular Degeneration

X-linked Retinoschisis

Up to 40 patients with X-linked Retinoschisis

Other Retinal Dystrophies

Up to 40 patients with other retinal dystrophies

Primary outcome measure

  • Operational feasibility of testing moderate to profound vision impaired patients with various retinal dystrophies on a battery of visual assessments [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Shawn Yu, OD

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

Locations

Vision Research and Assessment Institute

Recruiting

Irvine, California, United States, 92612

Contacts

Shawn Yu, OD

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

More Information

Sponsor

Ray Therapeutics, Inc.

Last update posted

Jan 8, 2025

Last verified

Jan, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ray Therapeutics, Inc. on 2025-01-08.