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

• Register: ClinicalTrials.gov
• Last refreshed on: 6 May 2024
• Main ID: NCT02018692
• Date of registration: 17/12/2013
• Prospective Registration: Yes
• Primary sponsor: Sheba Medical Center
• Public title: The Effect of Oral Administration of 9-cis Rich Powder of the Alga Dunaliella Bardawil on Visual Functions in Adolescent Patients With Retinitis Pigmentosa
• Scientific title: The Effect of Oral Administration of 9-cis ß Carotene Rich Powder of the Alga Dunaliella Bardawil on Visual Functions in Adolescent Patients With Retinitis Pigmentosa
• Date of first enrolment: March 1, 2025
• Target sample size: 30
• Recruitment status: Not yet recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT02018692
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 1/Phase 2

Countries of recruitment

Israel

Contacts

• Name: Ygal Rotenstreich, MD
• Affiliation: Goldschleger Eye Research Institute, Sheba Medical Center, Tel Hashomer

• Name: Ygal Rotenstreich, MD

• Name: Ygal Rotenstreich, MD

Key inclusion & exclusion criteria

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/ ß-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



Age minimum: 12 Years
Age maximum: 18 Years
Gender: All

Health Condition(s) or Problem(s) studied

Retinitis Pigmentosa

Intervention(s)

Dietary Supplement: Alga Dunaliella Bardawil powder

Dietary Supplement: Placebo:Starch

Primary Outcome(s)

Mean binocular maximal scotopic electroretinogram b-wave response [Time Frame: up to weeks 72]

Secondary Outcome(s)

The area within the Dark adapted chromatic Goldamann Visual field in isopters in cm2 [Time Frame: On weeks 0, 24, 48, 72]

The area within Goldamann Visual field in isopters in cm2 [Time Frame: On weeks 0, 24, 48, 72]

Mean binocular maximal photopic electroretinogram b-wave response [Time Frame: On weeks 0, 24, 48, 72]

Objective visual field by chromatic multifocal pupillometer [Time Frame: On weeks 0,24,48,72]

Best-corrected visual acuity (EDTRS) [Time Frame: On weeks 0, 24, 48, 72]

Secondary ID(s)

SHEBA-13-9579-YR-CTIL

Source(s) of Monetary Support

Please refer to primary and secondary sponsors