The Effect of Oral Administration of 9-cis Rich Powder of the Alga Dunaliella Bardawil on Visual Functions in Adolescent Patients With Retinitis Pigmentosa
Primary Purpose
Retinitis Pigmentosa
Status
Not yet recruiting
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
Alga Dunaliella Bardawil powder
Placebo:Starch
Sponsored by
About this trial
This is an interventional treatment trial for Retinitis Pigmentosa
Eligibility 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
Sites / Locations
- Goldschleger Eye Research Institute, 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
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.
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 .
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)
Objective visual field by chromatic multifocal pupillometer
Full Information
NCT ID
NCT02018692
First Posted
December 17, 2013
Last Updated
January 15, 2023
Sponsor
Sheba Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02018692
Brief 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
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 1, 2024 (Anticipated)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sheba Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
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
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Alga Dunaliella Bardawil 9-cis beta Carotene Rich Powder
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo (Starch)
Arm Type
Placebo Comparator
Arm Description
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 .
Intervention Type
Dietary Supplement
Intervention Name(s)
Alga Dunaliella Bardawil powder
Intervention Description
9 cis beta carotene rich Alga Dunaliella Bardawil powder
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo:Starch
Intervention Description
Starch powder
Primary Outcome Measure Information:
Title
Mean binocular maximal scotopic electroretinogram b-wave response
Description
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.
Time Frame
up to weeks 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
On 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
On weeks 0, 24, 48, 72
Title
Mean binocular maximal photopic electroretinogram b-wave response
Description
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.
Time Frame
On weeks 0, 24, 48, 72
Title
Best-corrected visual acuity (EDTRS)
Time Frame
On weeks 0, 24, 48, 72
Title
Objective visual field by chromatic multifocal pupillometer
Time Frame
On weeks 0,24,48,72
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ygal Rotenstreich, MD
Phone
972-3-5302880
Email
Ygal.Rotenstreich@sheba.health.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ygal Rotenstreich, MD
Organizational Affiliation
Goldschleger Eye Research Institute, Sheba Medical Center, Tel Hashomer
Official's Role
Principal Investigator
Facility Information:
Facility Name
Goldschleger Eye Research Institute, Sheba Medical Center,
City
Tel Hashomer
ZIP/Postal Code
52621
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ygal Rotenstreich, MD
Phone
972-3-530-2880
Email
ygal.rotenstreich@sheba.health.gov.il
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
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
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
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 Rich Powder of the Alga Dunaliella Bardawil on Visual Functions in Adolescent Patients With Retinitis Pigmentosa
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