NCT02018692

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
33mo left

Started Mar 2026

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress7%
Mar 2026Dec 2028

First Submitted

Initial submission to the registry

December 17, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 23, 2013

Completed
12.2 years until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

October 6, 2025

Status Verified

September 1, 2025

Enrollment Period

2.8 years

First QC Date

December 17, 2013

Last Update Submit

September 30, 2025

Conditions

Retinitis Pigmentosa

Outcome Measures

Primary Outcomes (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.

    up to weeks 72

Secondary Outcomes (5)

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

    On weeks 0, 24, 48, 72

  • The area within Goldamann Visual field in isopters in cm2

    On weeks 0, 24, 48, 72

  • Mean binocular maximal photopic electroretinogram b-wave response

    On weeks 0, 24, 48, 72

  • Best-corrected visual acuity (EDTRS)

    On weeks 0, 24, 48, 72

  • Objective visual field by chromatic multifocal pupillometer

    On weeks 0,24,48,72

Study Arms (2)

Alga Dunaliella Bardawil 9-cis beta Carotene Rich Powder

EXPERIMENTAL

15 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.

Dietary Supplement: Alga Dunaliella Bardawil powderDietary Supplement: Placebo:Starch

Placebo (Starch)

PLACEBO COMPARATOR

The 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 .

Dietary Supplement: Alga Dunaliella Bardawil powderDietary Supplement: Placebo:Starch

Interventions

Alga Dunaliella Bardawil powderDIETARY_SUPPLEMENT

9 cis beta carotene rich Alga Dunaliella Bardawil powder

Alga Dunaliella Bardawil 9-cis beta Carotene Rich PowderPlacebo (Starch)
Placebo:StarchDIETARY_SUPPLEMENT

Starch powder

Alga Dunaliella Bardawil 9-cis beta Carotene Rich PowderPlacebo (Starch)

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Goldschleger Eye Research Institute, Sheba Medical Center,

Tel Litwinsky, 52621, Israel

Location

Related Publications (4)

  • 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.

    PMID: 23700011BACKGROUND

  • 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.

    PMID: 23482470BACKGROUND

  • 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.

    PMID: 19955196BACKGROUND

  • 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.

    PMID: 32573764DERIVED

MeSH Terms

Conditions

Retinitis Pigmentosa

Condition Hierarchy (Ancestors)

Eye Diseases, HereditaryEye DiseasesRetinal DystrophiesRetinal DegenerationRetinal DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Ygal Rotenstreich, MD

    Goldschleger Eye Research Institute, Sheba Medical Center, Tel Hashomer

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ygal Rotenstreich, MD

CONTACT

972-3-5302880Ygal.Rotenstreich@sheba.health.gov.il

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Electrophysiology Clinic, Goldschleger Eye Research Institute

Study Record Dates

First Submitted

December 17, 2013

First Posted

December 23, 2013

Study Start

March 1, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

October 6, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)