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The Effect of Oral Administration of 9-cis β Carotene Rich Powder of the Alga Dunaliella Bardawil

Primary Purpose

Retinitis Pigmentosa

Status

Active

Phase

Phase 1

Locations

Israel

Study Type

Interventional

Intervention

Alga Dunaliella Bardawil

Placebo (starch)

About this trial

This is an interventional treatment trial for Retinitis Pigmentosa

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Written informed consent to participate in the study.
Men or women aged 18 years or older.
Electroretinogram (ERG) responses compatible with the diagnosis of Retinitis Pigmentosa

Exclusion Criteria:

Current smokers.
Current use of Vitamin A/ beta carotene supplements.
Active arterial disease within 3 months of study entry such as unstable angina, myocardial infarction, transient ischemic attack (TIA), stroke, and coronary artery bypass graft (CABG) surgery.
History of malignancy, except basal or squamous cell skin carcinoma.
Pregnant women, women who are breast feeding, and women of childbearing potential who are not using chemical or mechanical contraception.
Uncontrolled hypertension defined as either resting diastolic blood pressure of >95mmHg (taken from the mean of 3 readings) or resting systolic blood Pressure of > 180 mmHg.
History of alcohol abuse or drug abuse, or both.
Patient plans to engage in vigorous exercise or an aggressive diet regimen.
Uncontrolled endocrine or metabolic disease.
Participation in another investigational drug study within 4 weeks of entry into this study.
Serious or unstable medical or psychological condition that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study.
Subject whose hormone replacement therapy (HRT) or oral contraceptive therapy (OCT) was initiated within the 3 month prior to enrollment.

Sites / Locations

Sheba Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Alga Dunaliella Bardawil 9-cis beta Carotene Rich Powder

Placebo (Starch)

Arm Description

50 patients will receive first the capsules containing the alga Dunaliella Bardawil 9-cis beta-Carotene rich powder and after 24 weeks of washout period will receive capsule containing placebo (Starch).

The other 50 Patients will receive first the placebo (Starch) capsules and after 24 weeks of washout period will receive capsules containing the alga Dunaliella Bardawil 9-cis beta-Carotene rich powder .

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

Best-corrected visual acuity (EDTRS)

Full Information

NCT ID

NCT01680510

First Posted

September 4, 2012

Last Updated

January 15, 2023

Sponsor

Sheba Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01680510

Brief Title

The Effect of Oral Administration of 9-cis β Carotene Rich Powder of the Alga Dunaliella Bardawil

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

September 2012 (Actual)

Primary Completion Date

December 31, 2024 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sheba Medical Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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 alga Dunaliella Bardawil accumulates high concentration of β -carotene when grown under appropriate conditions. The β -carotene of the alga is composed of approximately 50% of all-trans - β carotene and 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Retinitis Pigmentosa

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Crossover Assignment

Model Description

Alga vs. placebo

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Alga Dunaliella Bardawil 9-cis beta Carotene Rich Powder

Arm Type

Experimental

Arm Description

Arm Title

Placebo (Starch)

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Dietary Supplement

Intervention Name(s)

Alga Dunaliella Bardawil

Intervention Type

Other

Intervention Name(s)

Placebo (starch)

Primary Outcome Measure Information:

Title

Mean binocular maximal scotopic electroretinogram b-wave response

Description

Time Frame

At weeks 0, 24,48,72

Secondary Outcome Measure Information:

Title

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

Description

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.

Time Frame

at weeks 0, 24, 48, 72

Title

The area within Goldamann Visual field in isopters in cm2

Description

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

Time Frame

at weeks 0, 24, 48, 72

Title

Mean binocular maximal photopic electroretinogram b-wave response

Description

Time Frame

Weeks 0, 24, 48, 72

Title

Best-corrected visual acuity (EDTRS)

Time Frame

Weeks 0, 24, 48, 72

Other Pre-specified Outcome Measures:

Title

Objective visual field by chromatic multifocal pupillometer

Description

Objective evaluation of 76 point visual field using a chromatic multifocal pupillometer.

Time Frame

Weeks 0, 24,48,72

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Written informed consent to participate in the study. Men or women aged 18 years or older. Electroretinogram (ERG) responses compatible with the diagnosis of Retinitis Pigmentosa Exclusion Criteria: Current smokers. Current use of Vitamin A/ beta carotene supplements. Active arterial disease within 3 months of study entry such as unstable angina, myocardial infarction, transient ischemic attack (TIA), stroke, and coronary artery bypass graft (CABG) surgery. History of malignancy, except basal or squamous cell skin carcinoma. Pregnant women, women who are breast feeding, and women of childbearing potential who are not using chemical or mechanical contraception. Uncontrolled hypertension defined as either resting diastolic blood pressure of >95mmHg (taken from the mean of 3 readings) or resting systolic blood Pressure of > 180 mmHg. History of alcohol abuse or drug abuse, or both. Patient plans to engage in vigorous exercise or an aggressive diet regimen. Uncontrolled endocrine or metabolic disease. Participation in another investigational drug study within 4 weeks of entry into this study. Serious or unstable medical or psychological condition that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study. Subject whose hormone replacement therapy (HRT) or oral contraceptive therapy (OCT) was initiated within the 3 month prior to enrollment.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ygal Rotenstreich, Dr.

Organizational Affiliation

Sheba Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sheba Medical Center

City

Tel Hashomer

ZIP/Postal Code

52621

Country

Israel

12. IPD Sharing Statement

Citations:

PubMed Identifier

23700011

Citation

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.

Results Reference

background

PubMed Identifier

19955196

Citation

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.

Results Reference

background

PubMed Identifier

23482470

Citation

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.

Results Reference

background

PubMed Identifier

32573764

Citation

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.

Results Reference

derived

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The Effect of Oral Administration of 9-cis β Carotene Rich Powder of the Alga Dunaliella Bardawil

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