Figure 1. The AREDS2 Study Design. DHA = docosahexaenoic acid; EPA = eicosapentaenoic acid; AREDS = 500 mg vitamin C, 400 IU vitamin E, 15 mg beta-carotene, 80 mg zinc oxide and 2 mg cupric oxide. Note in the secondary randomisation, patients may have received variations of the AREDS formula (i.e., no beta-carotene, low-dose zinc, or no beta-carotene and low-dose zinc). Patients who were current smokers or had ceased smoking <1 year ago were randomised to treatments with no beta-carotene.

A secondary goal of the study was to see if modification to the original AREDS formulation (specifically, eliminating beta- carotene and lowering the dose of zinc) affected efficacy. The distribution of patients in the AREDS2 study is shown in Figure 1. Note there was no true placebo in AREDS2 as all participants in the study (including the ‘control’ group) received the original AREDS formulation or a modified AREDS formula based on the secondary randomisation.

The results of the AREDS2 study were somewhat surprising. It was found in primary analyses that neither DHA/EPA supplementation nor lutein/zeaxanthin supplementation added any additional protective benefit above and beyond the original AREDS formulation. sub-analyses, the use of omega 3 supplements still did not demonstrate any significant impact on AMD progression or visual acuity. This was contradictory to the previously presented data that high-dose DHA and EPA may lower the risk of AMD progression. However, the results from the AREDS2 study

Allowed with mandatory warning statement on the medicine label: “WARNING: Contains zinc, which may be dangerous if taken in large amounts or for a long period.”

Vitamin E (dl-alpha-tocopheryl acetate)