Clinical Trials in Israel / NCT02018692
Starting soon
Phase 1/2
The Effect of Oral Administration of 9-cis Rich Powder of the Alga Dunaliella Bardawil on Visual Functions in Adolescent Patients With Retinitis Pigmentosa
NCT02018692 · tracked via the Priya Life Science Israel tracker
Condition(s) studied
Retinitis Pigmentosa
Investigational drug(s) / intervention(s)
Alga Dunaliella Bardawil powderPlacebo:Starch
Alga Dunaliella Bardawil powder: 9 cis beta carotene rich Alga Dunaliella Bardawil powder
Placebo:Starch: Starch powder
Study summary
The aim of this study is to determine whether 9-cis-beta Caroten rich D. Brdawiil extract is effective in the treatment of retinitis pigmentosa in adolescent patients.
Eligibility
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
Primary outcome measure(s)
- Mean binocular maximal scotopic electroretinogram b-wave response — up to weeks 72
Using the protocol of the International Society for Clinical Electrophysiology of Vision and the "UTAS 3000" system (LKC Technologies, Gaithersburg, MD), full-field electroretinographic responses will be recorded from both eyes of each patient. For scotopic conditions, maximal ERG b-wave responses will be recorded following 30 minutes of dark adaptation.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Goldschleger Eye Research Institute, Sheba Medical Center, | Tel Litwinsky | Israel |
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Other trials for the same condition
9-cis Beta-Carotene-Rich Extract of Dunaliella Alga in Retinitis Pigmentosa Patients
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Rate of Progression of PCDH15-Related Retinal Degeneration in Usher Syndrome 1F
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT02018692 on ClinicalTrials.gov ↗ ← All trials in Israel