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

Exudative Age-related Macular Degeneration Clinical Trial

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01404845
• Other study ID #: 2011-A00922-39
• Status: Completed
• Phase: N/A
• First received: July 22, 2011
• Last updated: June 23, 2015
• Start date: September 2011
• Est. completion date: January 2015

Study information

• Verified date: June 2015
• Source: Affordance
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: January 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Exudative Age-related Macular Degeneration
• Macular Degeneration
• Wet Macular Degeneration

Intervention

Dietary Supplement:
• Nutrof Total
Nutrof Total : 2 capsules per day,during 8 months (5 mg Lutéine + 1 mg Zéaxanthine / capsule).
• food supplement without Lutein and Zeaxanthin
food supplement without Lutein and Zeaxanthin : 2 capsules per day, during 8 months.

Locations

Country	Name	City	State
France	Docteur Jean-Jacques Masella	Grenoble
France	Centre ophtalmologique Rabelais	Lyon

Sponsors (2)

Lead Sponsor	Collaborator
Affordance	Drescode

Country where clinical trial is conducted

France, 

References & Publications (28)

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* Note: There are 28 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Analysis of changes in macular pigment density	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	18 months	No