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:
2025-12-24 @ 3:28 PM
Ignite Modification Date:
2025-12-24 @ 3:28 PM
NCT ID:
NCT02018692
Eligibility Criteria:
Inclusion Criteria:
* Written informed consent to participate in the study.
* Adolescent 12-18 years old.
* Electroretinogram (ERG) responses compatible with the diagnosis of Retinitis Pigmentosa
Exclusion Criteria:
* Currently a smoker
* Current use of vitamin A/ β-carotene supplements
* Active arterial disease within 3 months prior to enrolment in the study, e.g. unstable angina, myocardial infarction, transient ischemic attack, stroke, coronary artery bypass graft surgery
* History of malignancy, excepting basal or squamous cell skin carcinoma
* Females who are pregnant, or breast feeding, or are premenopausal but not using chemical or mechanical contraception
* Uncontrolled hypertension, defined either as resting diastolic blood pressure \>95 mmHg (taken from the mean of 3 readings) or as resting systolic blood pressure \>180 mmHg
* History of alcohol abuse or drug abuse or both
* Intention to engage in vigorous exercise or an aggressive diet regimen
* Uncontrolled endocrine or metabolic disease
* Participation in another investigational drug study within 4 weeks prior to enrolment
* Serious or unstable medical or psychological condition which, in the opinion of the PI, would compromise the subject's safety or successful participation in the study
* Initiation of hormone replacement therapy or oral contraceptive therapy within 3 months prior to enrolment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
18 Years
Study:
NCT02018692
Study Brief:
Protocol Section:
NCT02018692