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


Enrollment:	200
Study Start Date:	September 2011
Study Completion Date:	January 2015
Primary Completion Date:	December 2014 (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 (Adult, Senior)
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

Locations


France
Docteur Jean-Jacques Masella
Grenoble, France, 38000
Centre ophtalmologique Rabelais
Lyon, France, 69003

Sponsors and Collaborators

Affordance

Drescode

Investigators


Principal Investigator:	Martine Mauget-faysse	Affordance

More Information

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Responsible Party:	Affordance
ClinicalTrials.gov Identifier:	NCT01404845 History of Changes
Other Study ID Numbers:	2011-A00922-39
Study First Received:	July 22, 2011
Last Updated:	June 23, 2015
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 Retinal Degeneration Retinal Diseases Eye Diseases

ClinicalTrials.gov processed this record on September 23, 2016