An observational study in Retinitis Pigmentosa, Choroideremia and Stargardt Macular Dystrophy, sponsored by Ray Therapeutics, Inc.. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-08.
Sponsored by Ray Therapeutics, Inc. · Observational
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.
The VRAI is a state-of-the-art research institute specifically for patients with low or very low vision due to diseases of the retina of the eye. The Institute is staffed by highly experienced Low Vision specialists and provides a comfortable, familiar environment for patient testing.
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.
278 studies on the registry are indexed under Retinitis Pigmentosa; 72 are open to participants now.
This study's planned enrollment of 120 is above the median of 52 across 87 observational studies indexed under Retinitis Pigmentosa.
Browse Retinitis Pigmentosa studies →Ray Therapeutics, Inc. is the lead sponsor of 5 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with moderate to profound vision impairment diagnosed with retinitis pigmentosa, choroideremia, or Stargardt macular dystrophy (also known as Stargardt disease), geographic atrophy from age-related macular degeneration, X-linked retinoschisis or other retinal dystrophies
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Up to 40 patients with Retinitis Pigmentosa
Up to 40 patients with Choroideremia
Up to 40 patients with Stargardt Macular Dystrophy also known as Stargardt Disease
Up to 40 patients with Geographic Atrophy from Age-related Macular Degeneration
Up to 40 patients with X-linked Retinoschisis
Up to 40 patients with other retinal dystrophies
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 20/70 - HM (depending upon indication) can perform specific tests of visual function with a measurable score.
Time frame: 3 months
To quantify patient-based measurement properties of each test modality (for the purposes of endpoint qualification)
Test-retest reliability on the same visit or on two different testing sessions on different days including determination of significant learning effects or other scoring variables that impact variability.
Time frame: 2 years
To quantify assessor-based measurement properties of each test modality (for the purposes of endpoint qualification)
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.
Time frame: 2 years
Plan to share: No
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Ray Therapeutics, Inc.