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

NCT01404845 | Completed

• 1 other identifier: 2011-A00922-39
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

Brief Summary

• 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.

Conditions

Exudative Age-related Macular Degeneration

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Comparative analysis of macular pigment density

  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

  18 months

Secondary Outcomes (1)

• Analysis of changes in macular pigment density

  18 months

Study Arms (2)

B: patients with wet AMD in one eye.

ACTIVE COMPARATOR

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; Dietary Supplement: food supplement without Lutein and Zeaxanthin

A :patients without retinal pathology

ACTIVE COMPARATOR

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; Dietary Supplement: food supplement without Lutein and Zeaxanthin

Interventions

Nutrof Total DIETARY_SUPPLEMENT

Nutrof Total : 2 capsules per day,during 8 months (5 mg Lutéine + 1 mg Zéaxanthine / capsule).

A :patients without retinal pathology; B: patients with wet AMD in one eye.

food supplement without Lutein and Zeaxanthin DIETARY_SUPPLEMENT

food supplement without Lutein and Zeaxanthin : 2 capsules per day, during 8 months.

A :patients without retinal pathology; B: patients with wet AMD in one eye.

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Affordance: lead
• Drescode: collaborator

Study Sites (2)

Docteur Jean-Jacques Masella

Grenoble, 38000, France

Location

Centre ophtalmologique Rabelais

Lyon, 69003, France

Location

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MeSH Terms

Interventions

Dietary Supplements; Lutein; Zeaxanthins

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Xanthophylls; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Pigments, Biological; Biological Factors

Study Officials

• Martine Mauget-faysse

  Affordance

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2011
• First Posted: July 28, 2011
• Study Start: September 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: January 1, 2015
• Last Updated: June 24, 2015

Record last verified: 2015-06

Locations

FR (2)