Observational Study to Assess Endpoint Operational Feasibility & Measurement Properties in Patients with Retinal Degeneration
NCT ID: NCT06375239
Last Updated: 2025-01-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
120 participants
OBSERVATIONAL
2024-04-05
2026-04-30
Brief Summary
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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.
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Detailed Description
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The study is a non-interventional prospective cohort study of up to 40 patients for each disease condition (Retinitis Pigmentosa, Choroideremia, Stargardt Macular Dystrophy, Geographic Atrophy from Age-related Macular Degeneration, X-linked Retinoschisis or other retinal dystrophies ).
Patients are scheduled for an initial visit where they are tested on a series of efficacy tests. Thereafter, patients will be invited to attend for a further visit up to two weeks and then periodically for up to one year. The objectives of the study are to evaluate how well patients use their vision, how the tests relate to activities of daily living, establish clinical meaningfulness, assess the impact of disease progression and the precision and accuracy of each test in the context of their eye condition.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Retinitis Pigmentosa
Up to 40 patients with Retinitis Pigmentosa
No interventions assigned to this group
Choroideremia
Up to 40 patients with Choroideremia
No interventions assigned to this group
Stargardt Macular Dystrophy (Stargardt Disease)
Up to 40 patients with Stargardt Macular Dystrophy also known as Stargardt Disease
No interventions assigned to this group
Geographic Atrophy from Age-related Macular Degeneration
Up to 40 patients with Geographic Atrophy from Age-related Macular Degeneration
No interventions assigned to this group
X-linked Retinoschisis
Up to 40 patients with X-linked Retinoschisis
No interventions assigned to this group
Other Retinal Dystrophies
Up to 40 patients with other retinal dystrophies
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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The Vision Research and Assessment Institute (VRAI)
UNKNOWN
Ray Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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Vision Research and Assessment Institute
Irvine, California, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RTx-VRAI-NHS01
Identifier Type: -
Identifier Source: org_study_id
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