Dose Ranging Study of Lutein Supplementation in Persons Over Age 60

The primary objective of this study is to evaluate the association of varying doses of oral supplementation of lutein with the resulting serum levels of lutein in people over age 60 who may or may not have AMD. Secondary objectives are to investigate the relationship between level of disease and lutein absorption 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 the eye with worst disease. AMD severity will be classified using Age-Related Eye Disease Study criteria for the definition of advanced AMD (Appendix 2). 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.