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NCT02018692 | NOT YET RECRUITING | Retinitis Pigmentosa

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

Sheba Medical Center

Information provided by (Responsible Party):

Dr. Ygal Rotenstreich

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.

Condition or disease

Retinitis Pigmentosa

Intervention/treatment

Alga Dunaliella Bardawil powder

Placebo:Starch

Phase

PHASE1

PHASE2

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 30 participants
Masking : QUADRUPLE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2025-03-01
Estimated Primary Completion Date : 2027-12-31
Estimated Study Completion Date : 2027-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 12 Years to 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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/ 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
The Effect of Oral Administration of 9-cis Rich Powder of the Alga Dunaliella Bardawil on Visual Functions in Adolescent Patients With Retinitis Pigmentosa

Location Details

NCT02018692

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How to Participate

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Locations

Not yet recruiting

Israel,

Goldschleger Eye Research Institute, Sheba Medical Center,

Tel Hashomer, Israel, 52621