This study will examine whether taking the vitamin lutein changes lutein blood levels.
Lutein, vitamin C, vitamin E and beta-carotene may be useful in treating the eye disease
age-related macular degeneration, but more information is needed to support this.
Age-related macular degeneration can significantly impair the ability to read, drive, and
carry out daily activities. It is the most common cause of vision loss in people over age
60. Lutein a carotenoid that occurs naturally in the retina (the back part of the eye),
especially the macula-the part of the retina that is important for fine, detailed vision.
Men and women 60 years of age and older, with or without age-related macular degeneration,
may be eligible for this study. Candidates will undergo the following tests:
1. Medical history and physical examination.
2. Eye examination-Includes evaluation of visual acuity, measurement of eye pressure,
examination of the lens, retina, pupils and eye movements, and photographs of the eye.
3. Visual field study-Examines the ability to see objects in the periphery. The subject
looks at a target on a screen and indicates when lights that appear in other places on
the screen are visible.
4. Flicker photometry-The subject looks at a flashing light and turns a knob until the
light stops flashing.
5. Blood tests-To measure blood levels of lutein and other carotenoids, liver function,
cholesterol and triglycerides.
Participants will be randomly assigned to take one of three dosages of lutein (2.5
milligrams, 5 milligrams or 10 milligrams) for 6 months and will be examined at follow-up
visits scheduled 1, 3, 6, 9 and 12 months after starting lutein. During these visits, many
of the exams described above will be repeated to evaluate the effects of lutein treatment on
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.
Men and women aged 60 years or older.
Patients ranging from no AMD with 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 their eye with worst disease will be eligible.
The ability to understand and sign an informed consent form prior to enrollment.
Ocular disease which confounds assessment of the retina other than age-related macular
degeneration including diabetic retinopathy, central serous choroidopathy, optic atrophy,
retinal vein occlusion, active uveitis, significant explained or unexplained visual field
loss, or any other type of retinopathy or retinal degeneration.
Chronic requirement for any systemic or ocular medication for other diseases such as
Patients has regularly been taking lutein supplements during the last 3 months or is
currently taking lutein supplements. The daily use of the new Centrum or Centrum Silver
or other similar multivitamins will be allowed but should be limited to a maximum of twice
Abnormal liver function tests.
Inability to be followed for a period of 1 year.
Acute potentially life-threatening illness such as heart attack in the last year,
malignant cancer or blood disease not in remission.
History of lung cancer.