Retinitis Pigmentosa Clinical Measures and Repeatability Testing of Potential Outcome Measures

Plain-language summary

This study assesses the reliability (repeatability) of clinical measures and potential outcome measures that could be used in retinitis pigmentosa, an inherited eye disease. It included people aged 12 and older with characteristic evidence of retinitis pigmentosa as well as healthy volunteers. It was conducted as a study with no assigned phase and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Completed

Sponsor

National Eye Institute (NEI)

Start date

9/27/2019

Estimated completion

7/19/2023

Countries

United States

Related genes

Locations

• Bethesda, United States

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

* 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.