Results of the Age-Related Eye Diseaes Study (AREDS) showed that a combination of high doses of oral antioxidant vitamins (C, E, beta-carotene) and zinc is effective in reducing the development of advanced age-related macular degeneration (AMD) in patients who are at moderate or greater risk of AMD. Observational data from case-control studies, such as the Eye Disease Case Control Study (EDCCS), show that persons with higher serum levels of individual carotenoids, including lutein/zeaxanthin, beta-carotene, alpha-carotene, and cryptoxanthin, had a statistically significant reduction in the risk of neovascular/exudative AMD. This was also reflected in an analysis of dietary histories of participants in the EDCCS, which demonstrated that persons with a higher intake of lutein had a reduced risk of AMD. Lutein is the major filter of ultraviolet radiation in plants and is the major component of the yellow pigment in the macula. The importance of lutein in the treatment of AMD is not known and was not evaluated in the AREDS because commercial preparations of lutein were not available at the start of that study. However, preparations of lutein, alone or within a multi-vitamin, are now available and are being advertised as being helpful in the prevention of eye disease, despite the fact that even the basic information regarding the effects of different doses of supplementation with lutein on the plasma levels is not yet available. This pilot study will provide information on the effect of ingesting various levels of oral lutein supplements on serum lutein concentration in persons over age 60. This dose ranging study will provide data that may be useful in the design of future clinical trials of lutein. It may also provide useful information demonstrating whether the severity of AMD is associated with a decreased ability to absorb lutein as measured by serum lutein concentrations. The primary objective of this study is to evaluate the association of varying doses of oral supplementation of lutein with the resulting plasma levels of lutein in people over age 60 who may or may not have age-related macular degeneration. Secondary objectives are to investigate the relationship between level of disease and lutein absolution and to assess change in macular pigment. Assessment of macular pigment is not routinely performed in this patient population. Including this assessment in the current study will further attempts to standardize its implementation. If results appear to warrant further study, a placebo-controlled study may be appropriate. Patients will range from those with no AMD and little or no drusen in either eye through end stage AMD (geographic atrophic, retinal pigment epithelial detachment, or other signs of neovascular/exudative disease) in at least one eye. AMD severity will be classified using Age-Related Eye Disease Study criteria for the definition of advanced AMD. Development of a safety profile is not a specific objective of this study. To this point in time, the available published data have not indicated any safety concerns. However, due to the lack of complete knowledge of potential toxicities, safety assessments will be performed at all scheduled study visits. These safety assessments include: visual acuity, complete ophthalmic examination, fundus photos, liver function tests, visual field tests, and a side-effect questionnaire from the AREDS. Should safety concerns arise, adverse event rates can be compared to the AREDS, which is based on the same study population. Forty-five participants have been enrolled and all patients have completed their 6 month visit and a majority of patients have completed thei final one-year visit. The study is anticipated to be completed by April 2003.
