Macular Pigment Density Evolution in Unilateral Wet AMD Versus Non AMD Patients With or Without Lutein and Zeaxanthine Supplementation - Full Text View

Purpose

•Purpose: Age-related Macular Degeneration ( AMD) is the leading cause of blindness and visual impairment in industrialized countries. The macular pigment, composed of carotenoid derivatives (lutein and zeaxanthin), may play an important role in the occurrence of AMD. An increase in macular pigment following dietary supplementation with lutein and zeaxanthin could allow early treatment with such supplements in subjects with a high risk of AMD, and encourage them to change their eating habits.

•Primary outcome:

Comparative analysis of the density and evolution of the density of macular pigment:

In patients without any retinal pathology who underwent cataract surgery 1 month previously
In the non-exudative eye of patients with exudative AMD in one eye by analyzing the density and evolution of the density of macular pigment in the non-exudative eye
- Secondary outcomes:

Analysis of changes in macular pigment density after taking food supplements (Nutrof Total versus comparator):

Time taken to reach the maximum plateau of macular pigment density (no increase in density between 2 measurements)
Time taken to return to the baseline macular pigment density after cessation of supplementation
- Study design :

Pilot study -Prospective, randomised, double-masked, comparative, multicenter.

Condition	Intervention
Exudative Age-related Macular Degeneration	Dietary Supplement: Nutrof Total Dietary Supplement: food supplement without Lutein and Zeaxanthin


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Basic Science
Official Title:	Assessment of the Evolution of Macular Pigment Density in Two Distinct Populations, Before and After Supplementation With Nutrof Total Versus Dietary Supplement Without Lutein and Zeaxanthin, Using the Macular Pigment Module of Visucam 200 or Visucam 500 (Zeiss).

Resource links provided by NLM:

Genetics Home Reference related topics: age-related macular degeneration

MedlinePlus related topics: Dietary Supplements Macular Degeneration

Drug Information available for: Lutein

U.S. FDA Resources

Further study details as provided by Affordance:

Primary Outcome Measures:

Comparative analysis of macular pigment density [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Comparative analysis of macular pigment density in patients who underwent cataract operation 1 month ago, without retinal pathology and in patients with exudative AMD in one eye by analyzing the density and evolution of the density of macular pigment in the non-exudative eye.

Optical density (OD)parameters of the macular pigments measured by an objective reflectometry method based on a 30° field image acquired by the Visucam 200 or 500 of Zeiss :

Area : where macular pigments could be detected

Max OD/Mean OD/ Volume : Maximum value/Mean Value/Sum of all OD in the area

Secondary Outcome Measures:

Analysis of changes in macular pigment density [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Analysis of changes in macular pigment density after taking food supplements (Nutrof Total versus comparator):
- Time taken to reach the maximum plateau of macular pigment density (no increase in density between 2 measurements)
- Time taken to return to the baseline macular pigment density after cessation of supplementation


Estimated Enrollment:	200
Study Start Date:	September 2011
Estimated Study Completion Date:	February 2013
Estimated Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: B: patients with wet AMD in one eye. group B: patients with wet AMD in one eye. In each group, A and B, half the patients will be randomized in a subgroup to Nutrof Total, and the other half in a subgroup to a food supplement not containing Lutein and Zeaxanthin.	Dietary Supplement: Nutrof Total Nutrof Total : 2 capsules per day,during 8 months (5 mg Lutéine + 1 mg Zéaxanthine / capsule). Dietary Supplement: food supplement without Lutein and Zeaxanthin food supplement without Lutein and Zeaxanthin : 2 capsules per day, during 8 months.
Active Comparator: A :patients without retinal pathology group A :patients without retinal pathology who underwent cataract surgery 1 month previously. In each group, A and B, half the patients will be randomized in a subgroup to Nutrof Total, and the other half in a subgroup to a food supplement not containing Lutein and Zeaxanthin.	Dietary Supplement: Nutrof Total Nutrof Total : 2 capsules per day,during 8 months (5 mg Lutéine + 1 mg Zéaxanthine / capsule). Dietary Supplement: food supplement without Lutein and Zeaxanthin food supplement without Lutein and Zeaxanthin : 2 capsules per day, during 8 months.

Eligibility


Ages Eligible for Study:	55 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

Both genders (male or female), ≥ 55 years of age.
Patients without any retinal pathology who underwent cataract surgery 1 month previously Or
Patients with neovascular AMD (Age-related macular Degeneration) in one eye.
Patients who gave their written consent

Exclusion Criteria:

Exclusion criteria related to the study:

Intolerance to the tested product
Change in fundus image
Patients already taking Nutrof Total or similar supplements containing Lutein and Zeaxanthin
Allergy to mydriatics

Exclusion criteria for ophthalmologic reasons:

o Ocular diseases or conditions whose presence might interfere with the measurement of optical density of macular pigment (e.g. cataract, diabetic retinopathy, optic atrophy, myopia> -6.5 Diopters)

Exclusion criteria for systemic reasons:

o Medical or surgical history, disorder or disease (e.g. severe organic disease, acute or chronic: liver disease, endocrine, neoplastic, hematologic, infectious diseases, severe psychiatric disorder, significant cardiovascular abnormalities, etc...) and / or aggravating factors or structural defect, considered as being inconsistent with the study by the investigator.

Exclusion criteria for general reasons:

Inability of the patient to understand the study procedures and to give informed consent.
Ward of court
Patient not covered by the social security scheme
Pregnancy

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01404845

Contacts


Contact: Martine Mauget-Faysse	33(0)478950908	mauget_faysse@hotmail.com

Locations


France
Docteur Jean-Jacques Masella	Not yet recruiting
Grenoble, France, 38000
Contact: Jean-Jacques Masella +33(0)476120060 jj.masella@wanadoo.fr
Principal Investigator: Jean-Jacques Masella
Centre ophtalmologique Rabelais	Not yet recruiting
Lyon, France, 69003
Contact: Martine Mauget-Faysse +33(0)478950908 mauget_faysse@hotmail.com
Principal Investigator: Martine Mauget-Faysse
Sub-Investigator: Maddalena Quaranta-El Maftouhi

Sponsors and Collaborators

Affordance

Drescode

Investigators


Principal Investigator:	Martine Mauget-faysse	Affordance

More Information

Publications:

Resnikoff S, Pascolini D, Etya'ale D, Kocur I, Pararajasegaram R, Pokharel GP, Mariotti SP. Global data on visual impairment in the year 2002. Bull World Health Organ. 2004 Nov;82(11):844-51. Epub 2004 Dec 14.

Jager RD, Mieler WF, Miller JW. Age-related macular degeneration. N Engl J Med 2008;358(24):2606-17.

Whitehead AJ, Mares JA, Danis RP. Macular pigment: a review of current knowledge. Arch Ophthalmol. 2006 Jul;124(7):1038-45. Review.

Antioxidant status and neovascular age-related macular degeneration. Eye Disease Case-Control Study Group. Arch Ophthalmol. 1993 Jan;111(1):104-9. Erratum in: Arch Ophthalmol 1993 Nov;111(11):1499. Arch Ophthalmol 1993 Sep;111(9):1228, 1993 Oct;111(10):1366.

Gale CR, Hall NF, Phillips DI, Martyn CN. Lutein and zeaxanthin status and risk of age-related macular degeneration. Invest Ophthalmol Vis Sci. 2003 Jun;44(6):2461-5.

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.

Tan JS, Wang JJ, Flood V, Rochtchina E, Smith W, Mitchell P. Dietary antioxidants and the long-term incidence of age-related macular degeneration: the Blue Mountains Eye Study. Ophthalmology. 2008 Feb;115(2):334-41. Epub 2007 Jul 30.

Cho E, Hankinson SE, Rosner B, Willett WC, Colditz GA. Prospective study of lutein/zeaxanthin intake and risk of age-related macular degeneration. Am J Clin Nutr. 2008 Jun;87(6):1837-43.

VandenLangenberg GM, Mares-Perlman JA, Klein R, Klein BE, Brady WE, Palta M. Associations between antioxidant and zinc intake and the 5-year incidence of early age-related maculopathy in the Beaver Dam Eye Study. Am J Epidemiol. 1998 Jul 15;148(2):204-14.

Cho E, Seddon JM, Rosner B, Willett WC, Hankinson SE. Prospective study of intake of fruits, vegetables, vitamins, and carotenoids and risk of age-related maculopathy. Arch Ophthalmol. 2004 Jun;122(6):883-92.

Beatty S, Murray IJ, Henson DB, Carden D, Koh H, Boulton ME. Macular pigment and risk for age-related macular degeneration in subjects from a Northern European population. Invest Ophthalmol Vis Sci. 2001 Feb;42(2):439-46.

Bone RA, Landrum JT, Mayne ST, Gomez CM, Tibor SE, Twaroska EE. Macular pigment in donor eyes with and without AMD: a case-control study. Invest Ophthalmol Vis Sci. 2001 Jan;42(1):235-40. Erratum in: Invest Ophthalmol Vis Sci 2001 Mar;42(3):548.

Bernstein PS, Zhao DY, Wintch SW, Ermakov IV, McClane RW, Gellermann W. Resonance Raman measurement of macular carotenoids in normal subjects and in age-related macular degeneration patients. Ophthalmology. 2002 Oct;109(10):1780-7.

Obana A, Hiramitsu T, Gohto Y, Ohira A, Mizuno S, Hirano T, Bernstein PS, Fujii H, Iseki K, Tanito M, Hotta Y. Macular carotenoid levels of normal subjects and age-related maculopathy patients in a Japanese population. Ophthalmology. 2008 Jan;115(1):147-57. doi: 10.1016/j.ophtha.2007.02.028.

Hammond BR Jr, Johnson EJ, Russell RM, Krinsky NI, Yeum KJ, Edwards RB, Snodderly DM. Dietary modification of human macular pigment density. Invest Ophthalmol Vis Sci. 1997 Aug;38(9):1795-801.

Berendschot TT, Goldbohm RA, Klöpping WA, van de Kraats J, van Norel J, van Norren D. Influence of lutein supplementation on macular pigment, assessed with two objective techniques. Invest Ophthalmol Vis Sci. 2000 Oct;41(11):3322-6.

Bone RA, Landrum JT, Guerra LH, Ruiz CA. Lutein and zeaxanthin dietary supplements raise macular pigment density and serum concentrations of these carotenoids in humans. J Nutr. 2003 Apr;133(4):992-8. Erratum in: J Nutr. 2003 Jun;133(6):1953.

Koh HH, Murray IJ, Nolan D, Carden D, Feather J, Beatty S. Plasma and macular responses to lutein supplement in subjects with and without age-related maculopathy: a pilot study. Exp Eye Res. 2004 Jul;79(1):21-7.

Wenzel AJ, Gerweck C, Barbato D, Nicolosi RJ, Handelman GJ, Curran-Celentano J. A 12-wk egg intervention increases serum zeaxanthin and macular pigment optical density in women. J Nutr. 2006 Oct;136(10):2568-73.

Bone RA, Landrum JT, Cao Y, Howard AN, Alvarez-Calderon F. Macular pigment response to a supplement containing meso-zeaxanthin, lutein and zeaxanthin. Nutr Metab (Lond). 2007 May 11;4:12.

Thurnham DI, Trémel A, Howard AN. A supplementation study in human subjects with a combination of meso-zeaxanthin, (3R,3'R)-zeaxanthin and (3R,3'R,6'R)-lutein. Br J Nutr. 2008 Dec;100(6):1307-14. doi: 10.1017/S0007114508971336. Epub 2008 Apr 11.

Huang LL, Coleman HR, Kim J, de Monasterio F, Wong WT, Schleicher RL, Ferris FL 3rd, Chew EY. Oral supplementation of lutein/zeaxanthin and omega-3 long chain polyunsaturated fatty acids in persons aged 60 years or older, with or without AMD. Invest Ophthalmol Vis Sci. 2008 Sep;49(9):3864-9. doi: 10.1167/iovs.07-1420. Epub 2008 Apr 30.

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.

Trieschmann M, Beatty S, Nolan JM, Hense HW, Heimes B, Austermann U, Fobker M, Pauleikhoff D. Changes in macular pigment optical density and serum concentrations of its constituent carotenoids following supplemental lutein and zeaxanthin: the LUNA study. Exp Eye Res. 2007 Apr;84(4):718-28. Epub 2006 Dec 19.

Johnson EJ, Chung HY, Caldarella SM, Snodderly DM. The influence of supplemental lutein and docosahexaenoic acid on serum, lipoproteins, and macular pigmentation. Am J Clin Nutr. 2008 May;87(5):1521-9.

Zeimer M, Hense HW, Heimes B, Austermann U, Fobker M, Pauleikhoff D. [The macular pigment: short- and intermediate-term changes of macular pigment optical density following supplementation with lutein and zeaxanthin and co-antioxidants. The LUNA Study]. Ophthalmologe. 2009 Jan;106(1):29-36. doi: 10.1007/s00347-008-1773-4. German.


Responsible Party:	Mauget-Faysse Martine, MD, AFFORDANCE
ClinicalTrials.gov Identifier:	NCT01404845 History of Changes
Other Study ID Numbers:	2011-A00922-39
Study First Received:	July 22, 2011
Last Updated:	August 3, 2011
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Affordance:


exudative AMD dietary supplements macular pigment lutein	zeaxanthin Nutrof total in one eye

Additional relevant MeSH terms:


Macular Degeneration Wet Macular Degeneration Eye Diseases Retinal Degeneration Retinal Diseases

ClinicalTrials.gov processed this record on March 01, 2015