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NCT03845218

Retinitis Pigmentosa Clinical Measures and Repeatability Testing of Potential Outcome Measures

Sponsor: National Eye Institute (NEI)

View on ClinicalTrials.gov

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 cure, but treatment and diagnosis can be guided by certain tests. Researchers want to see how well these tests capture stages of RP. Objectives: To find out how well certain tests track changes in retinitis pigmentosa. Eligibility: People ages 12 and older with RP Healthy volunteers ages 18 and older with no evidence of RP Design: Participants will be screened in another protocol. Participants will have 2 visits about 6 weeks apart. Both will include all the tests below. Each visit will last 5-6 hours, or a visit can be split into 2 days. Participants will give their medical and eye history. Participants will have an eye exam. Their pupils will be dilated with eye drops. Participants will give blood samples. Pictures of participants retinas will be taken. Their retinas will be measured. Participants will take several eye tests. They will: Sit in a dark room and press a button when they see lights. View a bright background then press a button when they see lights. Look into a bowl and press a button when they see lights. Sit in the dark with their eyes patched. Then they will take eye-numbing drops and wear contacts as lights flash. A small electrode taped to their forehead will record signals from their retinas. Minors will give written consent to stay in the study when they turn 18. After the study ends, they may also be asked to give consent for researchers to continue to use their study information.

Official title: A Survey Study of Retinitis Pigmentosa (RP) Clinical Measures and Repeatability Testing of Potential Outcome Measures.

Key Details

Gender

All

Age Range

12 Years - 100 Years

Study Type

OBSERVATIONAL

Enrollment

Start Date

2019-09-27

Completion Date

2023-07-19

Last Updated

2026-08-20

Healthy Volunteers

Conditions

Retinitis Pigmentosa

* 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: 1. Participant must be 18 years of age or older. 2. Participant must understand and sign the protocol s informed consent document. 3. 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.

Locations (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States