Retinitis PigmentosaDEFINE-IRDNCT07502664
Development and Evaluation of Functional Visual Field and Navigation Endpoints in Moderate to Profound Inherited Retinal Disease (DEFINE-IRD)
An observational study of Retinitis Pigmentosa and Stargardt Macular Dystrophy, run by Ray Therapeutics, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinitis Pigmentosa, Stargardt Macular Dystrophy, Stargardt Disease
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Feb 2026to Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with moderate to profound vision impairment diagnosed with retinitis pigmentosa or other retinal dystrophies.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Vision Research and Assessment Institute
Irvine, California, 92614
Reem Jaber, MS, CGC, 949-264-3793, info@vr-ai.com
About this study
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.
Read the 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.
- Conditions
- Retinitis Pigmentosa, Stargardt Macular Dystrophy, Stargardt Disease, Geographic Atrophy From Age-related Macular Degeneration, X-linked Retinoschisis, Retinal Dystrophies
- Medical subject headings
- Retinitis Pigmentosa, Stargardt Disease, Retinoschisis, Retinal Dystrophies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Retinitis Pigmentosa | Up to 25 patients with Retinitis Pigmentosa | |
| Other Retinal Dystrophies | Up to 25 patients with Other Retinal Dystrophies |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 20/200 - HM (depending upon indication) can perform specific tests of visual function with a measurable score.
Measured: 3 months
Secondary outcomes (2)
To quantify patient-based measurement properties of each test modality (for the purposes of endpoint qualification)
Test-rest reliability on the same visit or on two different testing sessions on different days including determination of significant learning effects of other scoring variables that impact variability.
Measured: 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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2026
- Study start19 Feb 2026
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinitis PigmentosaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ray Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07502664
- Sponsor's protocol ID
- RTx-VRAI-NHS02 (DEFINE-IRD)
- Acronym
- DEFINE-IRD
- Status last verified
- Mar 2026
- First submitted
- 24 Mar 2026
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of Functional Visual Field and Navigation Endpoints in Moderate to Profound Inherited Retinal Disease (DEFINE-IRD)
- ClinicalTrials.gov ID
- NCT07502664
- Acronym / sponsor ID
- DEFINE-IRD / RTx-VRAI-NHS02 (DEFINE-IRD)
- Conditions
- Retinitis Pigmentosa, Stargardt Macular Dystrophy, Stargardt Disease, Geographic Atrophy From Age-related Macular Degeneration, X-linked Retinoschisis, Retinal Dystrophies
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Ray Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Feb 2026 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 31 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retinitis Pigmentosa | – | –Up to 25 patients with Retinitis Pigmentosa |
| Other Retinal Dystrophies | – | –Up to 25 patients with Other Retinal Dystrophies |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with moderate to profound vision impairment diagnosed with retinitis pigmentosa or other retinal dystrophies.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Operational feasibility of testing moderate to profound vision impaired patients with various retinal dystrophies on a battery of visual assessments
Time frame: 3 months
Determining how many patients in the visual range 20/200 - HM (depending upon indication) can perform specific tests of visual function with a measurable score.
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
Related trials for Retinitis Pigmentosa
RecruitingPhase 1
Safety of Cultured Allogeneic Adult Umbilical Cord or Placental Derived Mesenchymal Stem Cell Exosomes for NAION
Eye Diseases, Retinitis Pigmentosa
RecruitingObservational study
Rod and Cone Mediated Function in Retinal Disease
Retinal Degeneration, Retinitis Pigmentosa
RecruitingPhase 1/2
A Study to Investigate the Safety of OpCT-001 in Adults Who Have Primary Photoreceptor Disease (CLARICO)
Primary Photoreceptor Disease, Retinitis Pigmentosa (RP)
RecruitingEarly Phase 1
Safety and Tolerability Study of Gene Editing Drug ZVS203e in Participants With Retinitis Pigmentosa
Retinitis Pigmentosa
RecruitingPhase 3
A 24-Month Trial of NPI-001 for the Preservation of Photoreceptors in Retinitis Pigmentosa Associated With Usher Syndrome
Retinitis Pigmentosa (RP), Usher Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retinitis Pigmentosa and Stargardt Macular Dystrophy, run by Ray Therapeutics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Reem Jaber, MS, CGC (949-264-3793, info@vr-ai.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.