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
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Mean binocular maximal scotopic electroretinogram b-wave response
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Mean binocular maximal scotopic electroretinogram b-wave response
时间窗: At 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 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.
次要结局
- Best-corrected visual acuity (EDTRS)(Weeks 0, 24, 48, 72)
- The area within the Dark adapted chromatic Goldamann Visual field in isopters in cm2(at weeks 0, 24, 48, 72)
- The area within Goldamann Visual field in isopters in cm2(at weeks 0, 24, 48, 72)
- Mean binocular maximal photopic electroretinogram b-wave response(Weeks 0, 24, 48, 72)
研究者
Dr. Ygal Rotenstreich
Director of Hereditary Retinal Diseases and Electrophysiology Clinic
Sheba Medical Center