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
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 30
- 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
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.
详细描述
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.
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
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent to participate in the study.
- •Adolescent 12-18 years old.
- •Electroretinogram (ERG) responses compatible with the diagnosis of Retinitis Pigmentosa
排除标准
- •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
结局指标
主要结局
Mean binocular maximal scotopic electroretinogram b-wave response
时间窗: up to weeks 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
- Objective visual field by chromatic multifocal pupillometer(On weeks 0,24,48,72)
- The area within the Dark adapted chromatic Goldamann Visual field in isopters in cm2(On weeks 0, 24, 48, 72)
- The area within Goldamann Visual field in isopters in cm2(On weeks 0, 24, 48, 72)
- Best-corrected visual acuity (EDTRS)(On weeks 0, 24, 48, 72)
- Mean binocular maximal photopic electroretinogram b-wave response(On weeks 0, 24, 48, 72)
研究者
Dr. Ygal Rotenstreich
Director, Electrophysiology Clinic, Goldschleger Eye Research Institute
Sheba Medical Center