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

Retinitis Pigmentosa Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01680510
• Other study ID #: SHEBA-12-9373-YR-CTIL
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: September 1, 2012
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Retinitis
• Retinitis Pigmentosa

Intervention

Dietary Supplement:
• Alga Dunaliella Bardawil

Other:
• Placebo (starch)

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Tel Hashomer

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Objective visual field by chromatic multifocal pupillometer	Objective evaluation of 76 point visual field using a chromatic multifocal pupillometer.	Weeks 0, 24,48,72
Primary	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.	At weeks 0, 24,48,72
Secondary	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.	at weeks 0, 24, 48, 72
Secondary	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.	at weeks 0, 24, 48, 72
Secondary	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.	Weeks 0, 24, 48, 72
Secondary	Best-corrected visual acuity (EDTRS)		Weeks 0, 24, 48, 72