Night Blindness Clinical Trial
Official title:
Treatment of Congenital Stationary Night Blindness With an Alga Containing High Dose of Beta Carotene
To assess the effect of oral administration of the alga Dunaliella bardawil containing approximately 50% all-trans beta-carotene and 50% 9-cis beta-carotene isomers on visual functions patients with Congenital Stationary Night Blindness {Fundus albipunctatus).
| Status | Completed |
| Enrollment | 7 |
| Est. completion date | July 2010 |
| Est. primary completion date | August 2009 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 75 Years |
| Eligibility |
Inclusion Criteria: - Written informed consent to participate in the study. - Men or women aged 18 years or older - Diagnosed with Fundus albipunctatus 1. Isolated rod response markedly reduced (less than 20% of normal)after 20 minutes dark adaptation and improved by 50% after 2 hours 2. Negative maximal response (a wave to b wave ratio less than 2) 3. Retinal midperipheral white dots (More than 3000 dots) 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. - Active liver disease or hepatic dysfunction as defined by elevations of 2.0 times the ULN in any of the following liver function tests: ALT, AST or bilirubin. - Serum CPK > 2.0 times ULN in visit 0 - TSH above the normal range. - Newly diagnosed diabetes within 3 months. - 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. - Serum creatinine > 2.0 mg/dl before the treatment phase, +3 proteinuria in urine dipstick, or a history of renal transplantation before the treatment period. - Subject whose hormone replacement therapy (HRT) or oral contraceptive therapy (OCT) was initiated within the 3 month prior to enrollment. - Forbidden medications: the combination of PPAR alpha agonists-fibric acid derivatives, PPAR gamma agonists. |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Israel | Sheba Medical Center | Tel Hashomer |
| Lead Sponsor | Collaborator |
|---|---|
| Sheba Medical Center |
Israel,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Electroretinogram responses | Three months | Yes | |
| Secondary | Visual acuity | Three Months | Yes |