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

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ClinicalTrials.gov Identifier: NCT02018692
Recruitment Status : Not yet recruiting
First Posted : December 23, 2013
Last Update Posted : April 27, 2017
Sponsor:
Information provided by (Responsible Party):
Dr. Ygal Rotenstreich, Sheba Medical Center

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 Intervention/treatment Phase
Retinitis Pigmentosa Dietary Supplement: Alga Dunaliella Bardawil powder Dietary Supplement: Placebo:Starch Phase 1 Phase 2

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  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
Estimated Study Start Date : January 1, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019


Arm Intervention/treatment
Experimental: Alga Dunaliella Bardawil 9-cis beta Carotene Rich Powder
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 powder
9 cis beta carotene rich Alga Dunaliella Bardawil powder

Dietary Supplement: Placebo:Starch
Starch powder

Placebo Comparator: Placebo (Starch)
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 powder
9 cis beta carotene rich Alga Dunaliella Bardawil powder

Dietary Supplement: Placebo:Starch
Starch powder




Primary Outcome Measures :
  1. Mean binocular maximal scotopic electroretinogram b-wave response [ Time Frame: up to weeks 72 ]
    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.


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

  2. The area within Goldamann Visual field in isopters in cm2 [ Time Frame: On weeks 0, 24, 48, 72 ]
    Kinetic visual field will be recorded in both eyes. Area of vision within the isopter will be measured by software in cm2.

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

  4. Best-corrected visual acuity (EDTRS) [ Time Frame: On weeks 0, 24, 48, 72 ]
  5. Objective visual field by chromatic multifocal pupillometer [ Time Frame: On weeks 0,24,48,72 ]


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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02018692


Contacts
Contact: Ygal Rotenstreich, MD 972-3-5302880 Ygal.Rotenstreich@sheba.health.gov.il

Locations
Israel
Goldschleger Eye Research Institute, Sheba Medical Center, Not yet recruiting
Tel Hashomer, Israel, 52621
Contact: Ygal Rotenstreich, MD    972-3-530-2880    ygal.rotenstreich@sheba.health.gov.il   
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Ygal Rotenstreich, MD Goldschleger Eye Research Institute, Sheba Medical Center, Tel Hashomer

Publications:
Responsible Party: Dr. Ygal Rotenstreich, Director, Electrophysiology Clinic, Goldschleger Eye Research Institute, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT02018692     History of Changes
Other Study ID Numbers: SHEBA-13-9579-YR-CTIL
First Posted: December 23, 2013    Key Record Dates
Last Update Posted: April 27, 2017
Last Verified: April 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Retinitis
Retinitis Pigmentosa
Cone-Rod Dystrophies
Retinal Diseases
Eye Diseases
Eye Diseases, Hereditary
Retinal Dystrophies
Retinal Degeneration
Genetic Diseases, Inborn
Carotenoids
Beta Carotene
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Provitamins
Vitamins
Micronutrients
Growth Substances