NCT02018692Not yet recruitingPhase 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
The Effect of Oral Administration of 9-cis β Carotene Rich Powder of the Alga Dunaliella Bardawil on Visual Functions in Adolescent Patients With Retinitis Pigmentosa
Source: ClinicalTrials.gov · Last updated 6 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 17 Dec 2013
- Start date
- 1 Mar 2026
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Sheba Medical Center
- Diseases
- Retinitis pigmentosa
- NCT number
- NCT02018692
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 30
- From 1 Mar 2026 to the primary completion date, 31 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Participation in another investigational drug study within 4 weeks prior to enrolment
- Initiation of hormone replacement therapy or oral contraceptive therapy within 3 months prior to enrolment
Other illness
- History of malignancy, excepting basal or squamous cell skin carcinoma
- 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
- Uncontrolled endocrine or metabolic disease
- 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
Other
- Currently a smoker
- Current use of vitamin A/ β-carotene supplements
- Females who are pregnant, or breast feeding, or are premenopausal but not using chemical or mechanical contraception
- Intention to engage in vigorous exercise or an aggressive diet regimen
Who the study is looking for
- Written informed consent to participate in the study.
- Adolescent 12-18 years old.
- Electroretinogram (ERG) responses compatible with the diagnosis of Retinitis Pigmentosa
Age in the registry: 12 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Goldschleger Eye Research Institute, Sheba Medical Center, Coordinator of this site? Confirm its status | Tel HaShomer | Israel | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.