Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
AMI-P-307-C-001
Study information
Scientific title
Acronym
TOZAL
Study hypothesis
1. A novel nutritional supplement containing antioxidants and omega-3 fatty acids improves visual acuity in patients with atrophic (dry) age-related macular degeneration.
2. Micro-current stimulation in combination with a novel nutritional supplement containing antioxidants and omega-3 fatty acids improves visual acuity in patients with atrophic (dry) age-related macular degeneration.
Ethics approval
Independent Ethics Committee/Institutional Review Board approvals were received in April 2004 from the University of California Irvine Medical Center and Ohio State University.
Study design
Randomised prospective investigator, subject and sponsor masked trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Atrophic (dry) age-related macular degeneration
Intervention
Nutritional supplement for six months consisting of vitamin A 10,000 IU, beta-carotene 18,640 IU, vitamin E 200 IU, vitamin C 452 IU, zinc 69.6 mg, lutein 8 mg, taurine 400 mg, omega-3 fatty acids 300 mg in combination with a micro-current stimulation device or a sham micro-current stimulation device (randomised).
Intervention type
Supplement
Phase
Not Specified
Drug names
Nutritional supplement
Primary outcome measure
Measure the change in visual acuity from baseline at six months.
Secondary outcome measures
Measure objective signs of improved macular function.
Overall trial start date
01/04/2004
Overall trial end date
05/04/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Signed written consent
2. Between the ages of 50 and 90, inclusive
3. Any race or gender
4. Diagnosis of nonexudative (dry) Age-related Macular Degeneration (AMD) in at least one eye having more than ten large soft drusen 63 um in diameter, within 3,000 um of the fovea centre, documented on macular exam, retinal angiography and fundus photographs
5. Able to understand and comply with the requirements of the trial
6. Best Corrected Visual Acuity (BCVA) in the trial eye(s) of 20/32 to 20/125 inclusive as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) (logMAR)
7. Subjects must not have conditions that limit the view to the fundus (e.g. vitreous haemorrhage, cataracts, an epiretinal membrane). All subjects with more than or equal to 2+ nuclear opacities and/or significant central opacity (Posterior SubCapsular opacity [PSC] or Anterior SubCapsular opacity [ASC]) more than 1+ will undergo Potential Acuity Meter (PAM) testing. If the vision is more than or equal to two lines improved on PAM over standard acuity measurement then the subject will not be eligible for the trial
8. Subjects must be available for a minimum trial duration of approximately six months
9. Subjects must agree to take only the nutritional supplement that is provided during this study
10. Subjects or eyes must not meet any of the exclusion criteria
Participant type
Patient
Age group
Senior
Gender
Not Specified
Target number of participants
80
Participant exclusion criteria
Any of the following excluded a subject from the trial:
1. Currently enrolled in an ophthalmic clinical trial
2. Eyes with concomitant macular or choroidal disorders other than AMD and with indefinite signs of AMD
3. Eyes with a diagnosis of exudative (wet) AMD with active SubRetinal NeoVascularisation (SRNV) or Choroidal NeoVascularisation (CNV) lesions requiring laser photocoagulation in the study eye
4. Subjects with significant ocular lens opacities causing vision decrease
5. Subjects with amblyopia
6. Subjects with optic nerve disease (neuropathy, atrophy, papilledema), unstable glaucoma as defined by intraocular pressures greater than 25 mmHg, three or more glaucoma medications, C/D of 0.8 or greater and visual fields consistent with glaucoma; history of retina-vitreous surgery, degenerative myopia, active posterior intraocular inflammatory disease, chronic use of topical ocular steroid medications, vasoproliferative retinopathies (other than AMD), rhegmatogenous retinal detachment, and inherited macular dystrophies
7. Subjects with demand type pacemakers or epilepsy
8. Subjects with uncontrolled hypertension (defined as diastolic of 90 or greater and systolic of 150 or greater)
9. Subjects with recent history (within the previous year) of cerebral vascular disease manifested with Transient Ischaemic Attacks (TIAs) or cerebral vascular accidents (CVAs)
10. Subjects with a history of Acquired Immune Deficiency Syndrome (AIDS)
11. Subjects who have received any previous experimental procedure in either eye or the use of any investigational drug or treatment within 30 days prior to enrolling in the trial
12. Subjects who have had intraocular surgery in trial eye within three months prior to enrolling in the trial
13. Smokers or any tobacco use
Recruitment start date
01/04/2004
Recruitment end date
05/04/2005
Locations
Countries of recruitment
United States of America
Trial participating centre
119 Prospect Street
Ridgewood, NJ
7450
United States of America
Funders
Funder type
Industry
Funder name
Atlantic Medical, Inc. (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17324285
Publication citations
-
Results
Cangemi FE, TOZAL Study: an open case control study of an oral antioxidant and omega-3 supplement for dry AMD., BMC Ophthalmol, 2007, 7, 3, doi: 10.1186/1471-2415-7-3.