TOZAL Study: an open case control study of an oral antioxidant and omega-3 supplement for dry AMD.
BACKGROUND
The primary objective of this prospective study was to measure the change from baseline in visual function--Best-Corrected Visual Acuity (BCVA) via the Early Treatment Diabetic Retinopathy Study (ETDRS) chart, contrast sensitivity, central 10 degree visual fields and retinal imaging (angiograms and photographs) at 6 months in subjects with atrophic (dry) age-related macular degeneration treated with a targeted nutritional supplement.


METHODS
37 mixed gender patients with a mean age of 76.3 +/- 7.8 years were enrolled at 5 independent study sites and received standard of care with a novel formulation of a nutritional supplement. Results were compared to a placebo cohort constructed from the literature that was matched for inclusion and exclusion criteria. A paired t-test was used to test a null hypothesis and a two-sided alpha level of 0.05 was used to determine statistical significance.


RESULTS
76.7% of subjects receiving the nutritional supplement demonstrated stabilization or improvement of BCVA at 6 months. Subjects gained an average of 0.0541 logMAR or one-half of a line of visual acuity (VA) over the 6-month period. There was a statistically significant improvement in VA from baseline with P = .045. The results provide strong evidence that the treatment being studied produces an improvement in VA.


CONCLUSIONS
Treatment with this unique nutritional supplement increased VA above the expected baseline decrease in the majority of patients in this population with dry macular degeneration. The results of the TOZAL study agree with the LAST and CARMIS studies and are predictive for positive visual acuity outcomes in the AREDS II trial. However, patients will likely require supplementation for longer than 6 months to effect changes in additional visual parameters.
Cangemi
Francis E
FE
Vitreo-Retinal Associates of New Jersey, Ridgewood, New Jersey 07450, USA. franciscangemi@aol.com
D000284:Administration, Oral; D000368:Aged; D000369:Aged, 80 and over; D000975:Antioxidants / Q000008:administration & dosage* / Q000627:therapeutic use; D016022:Case-Control Studies; D015350:Contrast Sensitivity / Q000187:drug effects; D019587:Dietary Supplements; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D015525:Fatty Acids, Omega-3 / Q000008:administration & dosage* / Q000627:therapeutic use; D005260:Female; D005451:Fluorescein Angiography; D005500:Follow-Up Studies; D005654:Fundus Oculi; D006801:Humans; D014975:Lutein / Q000008:administration & dosage; D008268:Macular Degeneration / Q000188:drug therapy* / Q000473:pathology / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D013654:Taurine / Q000008:administration & dosage; D016896:Treatment Outcome; D014792:Visual Acuity / Q000502:physiology*; D015032:Zinc / Q000008:administration & dosage
D000975:Antioxidants; D015525:Fatty Acids, Omega-3; D013654:Taurine; D015032:Zinc; D014975:Lutein