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Retinitis PigmentosaPhase 1/2NCT02018692

The Effect of Oral Administration of 9-cis Rich Powder of the Alga Dunaliella Bardawil on Visual Functions in Adolescent Patients With Retinitis Pigmentosa

A Phase 1/2 study testing Alga Dunaliella Bardawil powder in people with Retinitis Pigmentosa, run by Sheba Medical Center at 1 site in Israel.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 12 to 18 years
Conditions the study is for
Retinitis Pigmentosa
What is being tested?
Alga Dunaliella Bardawil powder
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteIsrael
Study dates
1 Mar 2026to 31 Dec 2028
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Written informed consent to participate in the study.
  • Adolescent 12-18 years old.
  • Electroretinogram (ERG) responses compatible with the diagnosis of Retinitis Pigmentosa

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ygal Rotenstreich, MD contact

972-3-5302880

Ygal.Rotenstreich@sheba.health.gov.il

Israel1 site

  • Goldschleger Eye Research Institute, Sheba Medical Center,

    Tel HaShomer, 52621

    Ygal Rotenstreich, MD, 972-3-530-2880, ygal.rotenstreich@sheba.health.gov.il

Other trials in Israel

About this study

Official title: 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

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.

Read the detailed description

Retinitis pigmentosa is a genetically disease consisting of progressive retinal degeneration starting in the rods. Its prevalence is 1:4000 people and is the fourth most common blinding disease in Israel in 2004 [7% of all blindness]. The investigators treated a non-progressive form of the disease [Fundus Albipunctatus] by oral therapy of the food supplement made from alga Dunaliella Bardawil composed of approximately 50% 9-cis β-carotene.

The 9-cis β -carotene has been shown to be a precursor of 9-cis retinoic acid both in-vitro in human intestinal mucosa and in-vivo in a ferret, perfused with 9-cis b-carotene. The night vision, as measured objectively by electroretinography (ERG) more than doubled in six patients tested following treatment. The visual field was also improved significantly. In a more recent study the investigators treated 29 retinitis pigmentosa patients with the 9-cis b Carotene algae Dunaliella Bardawil in a double masked placebo control cross over trial. Significant improvement in retinal function was recorded in 34% of the patients.

As a natural extension of this study we will perform a double-masked, randomized, crossover, placebo-controlled study for adolescent patients. Longer treatment duration will be tested: a 24 week treatment with either the 9-cis β-carotene-rich capsules or placebo followed by an additional a 24 week treatment with the other capsules and a wash-out period of 24 weeks between this two type of treatments. We predict that with this study design a maximal/increased therapeutic effect as well as efficient washout will be achieved.

Being tested
Alga Dunaliella Bardawil powder, Placebo:Starch
Medical subject headings
Retinitis Pigmentosa

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Alga Dunaliella Bardawil powderDietary supplement

    9 cis beta carotene rich Alga Dunaliella Bardawil powder

  • Placebo:StarchDietary supplement

    Starch powder

Study groups in NCT02018692
Study groupRoleWhat they receive
Alga Dunaliella Bardawil 9-cis beta Carotene Rich PowderExperimental15 patients will first receive the capsules containing the alga Dunaliella Bardawil 9-cis beta-Carotene rich powder (5mg/Kg) for 24 weeks. After 24 weeks of washout period they will receive capsule containing placebo (Starch) for 24 weeks.
Receives: Dietary Supplement: Alga Dunaliella Bardawil powder; Dietary Supplement: Placebo:Starch
Placebo (Starch)Placebo comparatorThe other 15 Patients will receive first the placebo (Starch) capsules for 24 weeks. After 24 weeks of washout period they will receive capsules containing the alga Dunaliella Bardawil 9-cis beta-Carotene rich powder .
Receives: Dietary Supplement: Alga Dunaliella Bardawil powder; Dietary Supplement: Placebo:Starch

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean binocular maximal scotopic electroretinogram b-wave response

    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.

    Measured: up to weeks 72

Secondary outcomes (5)

  1. The area within the Dark adapted chromatic Goldamann Visual field in isopters in cm2

    Kinetic visual field for chromatic stimuli will be recorded in both eyes after 30 minutes of dark adaptation. Area of vision within the isopter will be measured by software in cm2.

    Measured: On weeks 0, 24, 48, 72

  2. The area within Goldamann Visual field in isopters in cm2

    Kinetic visual field will be recorded in both eyes. Area of vision within the isopter will be measured by software in cm2.

    Measured: On weeks 0, 24, 48, 72

  3. Mean binocular maximal photopic electroretinogram b-wave response

    Using the protocol of the International Society for Clinical Electrophysiology of Vision and the UTAS 3000 system (LKC Technologies, Gaithersburg, MD), full-field photopic electroretinographic responses will be recorded from both eyes of each patient.

    Measured: On weeks 0, 24, 48, 72

  4. Best-corrected visual acuity (EDTRS)

    Measured: On weeks 0, 24, 48, 72

  5. Objective visual field by chromatic multifocal pupillometer

    Measured: On weeks 0,24,48,72

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Dec 2013 (estimated)
  2. Study start1 Mar 2026 (estimated)
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02018692
Sponsor's protocol ID
SHEBA-13-9579-YR-CTIL
Status last verified
Sep 2025
First submitted
17 Dec 2013
Last updated
6 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Rotenstreich Y, Belkin M, Sadetzki S, Chetrit A, Ferman-Attar G, Sher I, Harari A, Shaish A, Harats D. Treatment with 9-cis beta-carotene-rich powder in patients with retinitis pigmentosa: a randomized crossover trial. JAMA Ophthalmol. 2013 Aug;131(8):985-92. doi: 10.1001/jamaophthalmol.2013.147.

    PubMed 23700011

  • Skaat A, Sher I, Kolker A, Elyasiv S, Rosenfeld E, Mhajna M, Melamed S, Belkin M, Rotenstreich Y. Pupillometer-based objective chromatic perimetry in normal eyes and patients with retinal photoreceptor dystrophies. Invest Ophthalmol Vis Sci. 2013 Apr 17;54(4):2761-70. doi: 10.1167/iovs.12-11127.

    PubMed 23482470

  • Rotenstreich Y, Harats D, Shaish A, Pras E, Belkin M. Treatment of a retinal dystrophy, fundus albipunctatus, with oral 9-cis-beta-carotene. Br J Ophthalmol. 2010 May;94(5):616-21. doi: 10.1136/bjo.2009.167049. Epub 2009 Dec 2.

    PubMed 19955196

  • Schwartz SG, Wang X, Chavis P, Kuriyan AE, Abariga SA. Vitamin A and fish oils for preventing the progression of retinitis pigmentosa. Cochrane Database Syst Rev. 2020 Jun 18;6(6):CD008428. doi: 10.1002/14651858.CD008428.pub3.

    PubMed 32573764

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Alga Dunaliella Bardawil powder in people with Retinitis Pigmentosa, run by Sheba Medical Center at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 6 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ygal Rotenstreich, MD (972-3-5302880, Ygal.Rotenstreich@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean binocular maximal scotopic electroretinogram b-wave response (time frame: up to weeks 72). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02018692, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2025.

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