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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Affordance.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Drescode
Information provided by:
Affordance
ClinicalTrials.gov Identifier:
NCT01404845
First received: July 22, 2011
Last updated: August 3, 2011
Last verified: August 2011
  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:


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

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
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on August 21, 2014