Lutein for Age-Related Macular Degeneration

NCT00006202 | Completed Phase 2

• 2 other identifiers: 00020800-EI-0208
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.Medical history and physical examination.
2. 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. 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. 4.Flicker photometry-The subject looks at a flashing light and turns a knob until the light stops flashing.
5. 5.Blood tests-To measure blood levels of lutein and other carotenoids, liver function, cholesterol and triglycerides.

Conditions

Macular Degeneration

Keywords

Serum levels of Lutein; Age-Related Macular Degeneration; Safety; Toxicity

Interventions

Lutein DRUG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 glaucoma.
• 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 a day.
• 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.

Sponsors & Collaborators

• National Eye Institute (NEI): lead

Study Sites (1)

National Eye Institute (NEI)

Bethesda, Maryland, 20892, United States

Location

Related Publications (4)

• Machemer R, Steinhorst UH. Retinal separation, retinotomy, and macular relocation: II. A surgical approach for age-related macular degeneration? Graefes Arch Clin Exp Ophthalmol. 1993 Nov;231(11):635-41. doi: 10.1007/BF00921957.

  PMID: 8258397 BACKGROUND

• de Juan E Jr, Loewenstein A, Bressler NM, Alexander J. Translocation of the retina for management of subfoveal choroidal neovascularization II: a preliminary report in humans. Am J Ophthalmol. 1998 May;125(5):635-46. doi: 10.1016/s0002-9394(98)00018-x.

  PMID: 9625547 BACKGROUND

• Seddon JM, Ajani UA, Sperduto RD, Hiller R, Blair N, Burton TC, Farber MD, Gragoudas ES, Haller J, Miller DT, et al. Dietary carotenoids, vitamins A, C, and E, and advanced age-related macular degeneration. Eye Disease Case-Control Study Group. JAMA. 1994 Nov 9;272(18):1413-20.

  PMID: 7933422 BACKGROUND

• Evans JR, Lawrenson JG. Antioxidant vitamin and mineral supplements for slowing the progression of age-related macular degeneration. Cochrane Database Syst Rev. 2023 Sep 13;9(9):CD000254. doi: 10.1002/14651858.CD000254.pub5.

  PMID: 37702300 DERIVED

MeSH Terms

Conditions

Macular Degeneration

Interventions

Lutein

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Xanthophylls; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Pigments, Biological; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: September 9, 2000
• First Posted: September 11, 2000
• Study Start: September 1, 2000
• Study Completion: August 1, 2003
• Last Updated: March 4, 2008

Record last verified: 2003-08

Locations

US (1)