Ireland
--:--IST
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
Phase
Phase 1/2
Started
2026-03-01
Last updated
2025-10-06

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

Sex
ALL
Min age
12 Years
Max age
18 Years
Healthy volunteers
No
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)

FacilityCityRegionStatus
Goldschleger Eye Research Institute, Sheba Medical Center, Tel Litwinsky Israel
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