Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-25 @ 5:03 AM
NCT ID:
NCT03845218
Eligibility Criteria:
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
100 Years
Study:
NCT03845218
Study Brief:
Protocol Section:
NCT03845218