Development and Evaluation of Functional Visual Field and Navigation Endpoints in Moderate to Profound Inherited Retinal Disease (DEFINE-IRD)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Retinitis Pigmentosa, Stargardt Macular Dystrophy, Stargardt Disease, Geographic Atrophy From Age-related Macular Degeneration. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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.
Primary outcome measures
- Operational feasibility of testing moderate to profound vision impaired patients with various retinal dystrophies on a battery of visual assessments [Time frame: 3 months]
Secondary outcome measures (2)
- To quantify patient-based measurement properties of each test modality (for the purposes of endpoint qualification) [Time frame: 2 years]
- To quantify assessor-based measurement properties of each test modality (for the purposes of endpoint qualification) [Time frame: 2 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Vision Research and Assessment Institute — Irvine
Identifiers
NCT: NCT07502664 · RTx-VRAI-NHS02 (DEFINE-IRD)