Actively Recruiting

Age: 18Years +
All Genders
ID07502664

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

Led by Ray Therapeutics, Inc. · Updated on 2026-03-31

25

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the operational feasibility and measurement properties of various visual function assessments for patients with moderate to profound inherited retinal diseases, including Retinitis Pigmentosa and other retinal dystrophies. The study focuses on tests sensitive to peripheral vision and functional abilities such as spatial orientation, mobility, and wayfinding. This observational, non-interventional research aims to improve and standardize efficacy endpoints for people with low vision. Participants include up to 50 patients divided into two groups: those with Retinitis Pigmentosa and those with other retinal dystrophies. The study does not involve treatment but assesses visual function through a battery of tests over time. The primary outcome is the feasibility of testing patients with moderate to profound vision impairment within three months, with secondary outcomes measuring patient- and assessor-based properties of each test modality over two years. During the study, participants will undergo various visual assessments designed to reflect real-life visual challenges. Researchers will collect data on the reliability and sensitivity of these tests. The study spans up to two years, emphasizing long-term evaluation of measurement tools. Participants' safety and compliance will be monitored, and the study supports the development of better testing methods for low vision conditions.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of bilateral retinitis pigmentosa or other retinal dystrophies impacting peripheral vision confirmed by previous eye exams
  • Best-corrected visual acuity between 20/200 and hand motion in at least one eye
  • Reasonably fluent in English or Spanish
  • Adults aged 18 years or older
Not Eligible

You will not qualify if you...

  • Cognitive impairment, memory loss, or dementia preventing informed consent or test completion
  • Any condition that interferes with participation or compliance with the study protocol
  • Current pregnancy as reported by the patient

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to 3 months

Participants undergo a series of visual function assessments to evaluate peripheral vision and real-world functional abilities such as spatial orientation, mobility, and wayfinding.

Multiple visits over 3 months

Long-term Monitoring

Duration - Up to 2 years

Participants are monitored to assess measurement properties of the visual tests over time for endpoint qualification.

Periodic visits during 2 years

Trial Site Locations

Total: 1 location

1

Vision Research and Assessment Institute

Irvine, California, United States, 92614

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Research Team

R

Reem Jaber, MS, CGC

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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