The Zeaxanthin and Visual Function Study - Full Text View

Sponsors and Collaborators:	Chrysantis, Inc. Kowa Company, Ltd. IMAGE TECHNOLOGIES INC.
Information provided by:	Chrysantis, Inc.
ClinicalTrials.gov Identifier:	NCT00564902

Purpose

To evaluate if supplementation of zeaxanthin (with or without Lutein) is beneficial to patients with early and moderate AMD.

Condition	Intervention
Age Related Macular Degeneration Cognition Disorders	Dietary Supplement: 3R 3'R Zeaxanthin

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Macular Degeneration

Drug Information available for: Lutein Zeaxanthin Carotenoids

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Efficacy Study
Official Title:	Randomized, Double Blind, Lutein Controlled Study of Zeaxanthin and Visual Function in Athropic Age Related Macular Degeneration Patients

Further study details as provided by Chrysantis, Inc.:

Primary Outcome Measures:

Change in MPOD from baseline [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Visual Acuity, Contrast Sensitivity, Color Vision, Glare Recovery, Lipofuscin pattern changes [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

Enrollment:	60
Study Start Date:	November 2007
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Placebo Comparator Lutein 9 mg	Dietary Supplement: 3R 3'R Zeaxanthin 8 mg per day during 12 months
B: Active Comparator 3R 3'R Zeaxanthin 8 mg, Lutein 8 mg per day during 12 months	Dietary Supplement: 3R 3'R Zeaxanthin 8 mg per day during 12 months
C: Active Comparator 3R 3'R Zeaxanthin 8 mg per day during 12 months	Dietary Supplement: 3R 3'R Zeaxanthin 8 mg per day during 12 months

Detailed Description:

To evaluate whether or not zeaxanthin supplementation raises macular pigment optic density (MPOD). Previous research has shown MPOD to mirror visual benefits for patients with age related atrophic macular degeneration (AMD) having visual symptoms (decreased visual acuity, contrast sensitivity, photostress glare recovery and NEI VFQ25 scores), but lower risk NEI / AREDS characteristics.

Eligibility

Ages Eligible for Study:	45 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

diagnosis of atrophic AMD (ICD9 362.51) by stereo bio-ophthalmoscopy and at least one vision degrading visual-psychophysical abnormality associated with AMD in one or both eyes.
clear non-lenticular ocular media (cornea, aqueous and vitreous)
free of advanced glaucoma and diabetes or any other ocular or systemic disease that could affect central or parafoveal macula visual function

Exclusion Criteria:

high risk retinal characteristics for advanced AMD or advanced AMD for which existing medical / surgical options are available
presence of ophthalmologically significant active exudative, AMD pathology by fluorescein angiography but also a single large drusen, >15, multiple intermediate drusen, parafoveal geographic atrophy or loss of vision in one eye due to advanced AMD
recent (within 6 months) cataract or retinal surgery
taking photosensitizing drugs such as phenothiazines and chloroquine
having taken lutein or zeaxanthin supplements within the past six months.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00564902

Locations

United States, Illinois
North Chicago VA Medical Center
North Chicago, Illinois, United States, 60064

Sponsors and Collaborators

Chrysantis, Inc.

Kowa Company, Ltd.

IMAGE TECHNOLOGIES INC.

Investigators

Principal Investigator:	Stuart Richer, Ph. D.	North Chicago VA Medical Center
Study Director:	William Stiles, M.D.	North Chicago VA Medical Center

More Information

Publications:

Delcourt C, Carrière I, Delage M, Barberger-Gateau P, Schalch W; POLA Study Group. Plasma lutein and zeaxanthin and other carotenoids as modifiable risk factors for age-related maculopathy and cataract: the POLA Study. Invest Ophthalmol Vis Sci. 2006 Jun;47(6):2329-35.

Schalch W, Cohn W, Barker FM, Köpcke W, Mellerio J, Bird AC, Robson AG, Fitzke FF, van Kuijk FJ. Xanthophyll accumulation in the human retina during supplementation with lutein or zeaxanthin - the LUXEA (LUtein Xanthophyll Eye Accumulation) study. Arch Biochem Biophys. 2007 Feb 15;458(2):128-35. Epub 2006 Nov 7.

Richer S, Stiles W, Statkute L, Pulido J, Frankowski J, Rudy D, Pei K, Tsipursky M, Nyland J. Double-masked, placebo-controlled, randomized trial of lutein and antioxidant supplementation in the intervention of atrophic age-related macular degeneration: the Veterans LAST study (Lutein Antioxidant Supplementation Trial). Optometry. 2004 Apr;75(4):216-30.

Richer S, Devenport J, Lang JC. LAST II: Differential temporal responses of macular pigment optical density in patients with atrophic age-related macular degeneration to dietary supplementation with xanthophylls. Optometry. 2007 May;78(5):213-9.

Leung IY, Sandstrom MM, Zucker CL, Neuringer M, Max Snodderly D. Nutritional manipulation of primate retinas. IV. Effects of n--3 fatty acids, lutein, and zeaxanthin on S-cones and rods in the foveal region. Exp Eye Res. 2005 Nov;81(5):513-29.

Neuringer M, Sandstrom MM, Johnson EJ, Snodderly DM. Nutritional manipulation of primate retinas, I: effects of lutein or zeaxanthin supplements on serum and macular pigment in xanthophyll-free rhesus monkeys. Invest Ophthalmol Vis Sci. 2004 Sep;45(9):3234-43.

Akbaraly NT, Faure H, Gourlet V, Favier A, Berr C. Plasma carotenoid levels and cognitive performance in an elderly population: results of the EVA Study. J Gerontol A Biol Sci Med Sci. 2007 Mar;62(3):308-16.

Thomson LR, Toyoda Y, Langner A, Delori FC, Garnett KM, Craft N, Nichols CR, Cheng KM, Dorey CK. Elevated retinal zeaxanthin and prevention of light-induced photoreceptor cell death in quail. Invest Ophthalmol Vis Sci. 2002 Nov;43(11):3538-49.

Responsible Party:	North Chicago VA Medical Center ( Stuart Richer Ph. D. )
Study ID Numbers:	CHRY1, IRB 07-046
Study First Received:	November 27, 2007
Last Updated:	April 15, 2008
ClinicalTrials.gov Identifier:	NCT00564902
Health Authority:	United States: Food and Drug Administration

Keywords provided by Chrysantis, Inc.:

Macular Pigment Optical Density
Skin Carotenoids
Lipofuscin
Photostress (Glare Recovery)

Visual Field Progression
Contrast Sensitivity
Color Vision
Cognitive Function

Study placed in the following topic categories:

Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Eye Diseases
Disease Progression
Retinal Degeneration
Macular Degeneration

Dementia
Carotenoids
Retinal Diseases
Cognition Disorders
Retinal degeneration
Delirium

ClinicalTrials.gov processed this record on January 15, 2009