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

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ClinicalTrials.gov Identifier: NCT01404845
Recruitment Status : Completed
First Posted : July 28, 2011
Last Update Posted : June 24, 2015
Sponsor:
Collaborator:
Drescode
Information provided by (Responsible Party):
Affordance

Study Description
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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.


Condition or disease Intervention/treatment Phase
Exudative Age-related Macular Degeneration Dietary Supplement: Nutrof Total Dietary Supplement: food supplement without Lutein and Zeaxanthin Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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).
Study Start Date : September 2011
Actual Primary Completion Date : December 2014
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Lutein
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Comparative analysis of macular pigment density [ Time Frame: 18 months ]

    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 :
  1. Analysis of changes in macular pigment density [ Time Frame: 18 months ]

    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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:
Delcourt C. Epidémiologie de la DMLA dans la population française. In: Soubrane G, Coscas G, Souied EH, editors. Les DMLAs (9ème édition). Rapport de la Société Française d'Ophtalmologie. Paris: Masson; 2007. p. 108-110.

Responsible Party: Affordance
ClinicalTrials.gov Identifier: NCT01404845     History of Changes
Other Study ID Numbers: 2011-A00922-39
First Posted: July 28, 2011    Key Record Dates
Last Update Posted: June 24, 2015
Last Verified: June 2015

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