Condition category
Eye Diseases
Date applied
27/12/2006
Date assigned
28/12/2006
Last edited
25/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Francis Cangemi

ORCID ID

Contact details

119 Prospect Street
Ridgewood
NJ
7450
United States of America

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 measures

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

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 (TIA’s) or cerebral vascular accidents (CVA’s)
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

Sponsor information

Organisation

Atlantic Medical, Inc. (USA)

Sponsor details

1213 Culbreth Drive
Wilmington
NC
28405
United States of America

Sponsor type

Industry

Website

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

Results - basic reporting

Publication summary

2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17324285

Publication citations

  1. 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.

Additional files

Editorial Notes