Status:
COMPLETED
The Effect of Oral Administration of 9-cis Rich Powder of the Alga Dunaliella Bardawil on Visual Functions im Patients With Retinitis Pigmentosa
Lead Sponsor:
Sheba Medical Center
Conditions:
Retinitis Pigmentosa
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Retinitis pigmentosa is a genetically determined disease consisting of progressive centripetal retinal degeneration starting in the rods outer segments. Its prevalence is 1:4000 people and is the four...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT01256697
Start Date
August 1 2008
End Date
January 1 2011
Last Update
December 20 2013
Active Locations (1)
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1
Sheba Medical Center
Tel Litwinsky, Israel