Status:
COMPLETED
Retinitis Pigmentosa Clinical Measures and Repeatability Testing of Potential Outcome Measures
Lead Sponsor:
National Eye Institute (NEI)
Conditions:
Retinitis Pigmentosa
Eligibility:
All Genders
12-100 years
Brief Summary
Background: Retinitis pigmentosa (RP) is a group of blinding eye diseases. It is caused mostly by mutations in photoreceptor-expressed genes. RP affects about 2 million people globally. There is no c...
Detailed Description
Precis Objective: The objective of this study is to investigate the nature of photoreceptor dysfunction in retinitis pigmentosa (RP) patients using focal static and kinetic psychophysical tests to de...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA for RP Participants:
- To be eligible, the following inclusion criteria must be met, where applicable.
- Participant must be 12 years of age or older.
- Participant (or legal guardian) must understand and sign the protocol s informed consent document.
- Participant must have evidence of RP as defined by characteristic ERG responses, visual fields, clinical exam and /or genetic testing.
- INCLUSION CRITERIA FOR HEALTHY VOLUNTEERS:
- To be eligible, the following inclusion criteria must be met:
- Participant must be 18 years of age or older.
- Participant must understand and sign the protocol s informed consent document.
- Participant must not have evidence of RP.
- EXCLUSION CRITERIA FOR ALL PARTICIPANTS:
- A participant is not eligible if any of the following exclusion criteria are present.
- Participant is actively receiving study therapy in another investigational study.
- Participant is started on (or changed dosage of) topical or systemic carbonic anhydrase inhibitor (CAI) treatment in the three months prior to enrollment.
- Participant is expected to be unable to comply with study procedures or follow-up visits.
- Participant has evidence of an ocular disease other than RP in either eye that may confound the outcome of the study (e.g., diabetic retinopathy with ten or more hemorrhages or microaneurysms, uveitis, pseudovitelliform macular degeneration, severe myopia).
- Participant is taking ocular or systemic medications known to be toxic to the lens, retina or optic nerve (e.g., ethambutol, chloroquine, or hydroxychloroquine).
- Participant has a condition that would preclude participation in the study (e.g., unstable medical status including blood pressure and glycemic control) by interfering with the participant s ability to engage in the required protocol evaluation and testing and/or comply with study visits.
- Participant is an NIH employee associated with this study.
- Participant is unable or unwilling to give informed consent that includes use of medical records and clinical samples for current and future research.
Exclusion
Key Trial Info
Start Date :
September 27 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 19 2023
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT03845218
Start Date
September 27 2019
End Date
July 19 2023
Last Update
October 3 2025
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892