Study of the Discriminating Power of a Blood Biomarker for Omega-3 Polyunsaturated Fatty Acid Content of the Retina for Age-related Macular Degeneration (AMD) (FATTY)

University Hospital Center (CHU) Dijon Bourgogne

Status

Completed

Conditions

Age-related Macular Degeneration

Treatments

Biological: faecal sampling (optional)

Biological: blood sampling

Study type

Observational

Funder types

Other

Identifiers

NCT04278300

CREUZOT 2019

Details and patient eligibility

About

Age-related macular degeneration is a chronic degenerative retinal disease, which can lead to a progressive loss of visual acuity without affecting peripheral vision. It is a public health problem as it remains the leading cause of visual impairment in people over 50 years of age in industrialized countries.

Age-related macular degeneration has two clinical forms:

Atrophic or dry form: progressive disappearance of photoreceptors, alteration of the pigmentary epithelium leading to a thinning of the macula.
Exudative or humid form: development of immature choroidal neo-vessels, leading to the formation of edema or intra or sub-retinal hemorrhage at the origin of the symptoms.

There are still many questions about the pathogenesis of age-related macular degeneration, and there is currently no etiological treatment. The disorder is thought to have a multifactorial, genetic and environmental origin.

Among the environmental risk factors, dietary intake of omega-3 polyunsaturated acids and its effect on the retina are factors that influence both the incidence and progression of the disease. However, intervention studies have not been able to demonstrate the preventive value of omega-3 polyunsaturated fatty acids. It is likely that the precise identification of patients who could benefit from this supplementation is necessary. Currently, the estimation of dietary intake of omega-3 polyunsaturated fatty acids is based on dietary surveys, which implies a number of limits. A blood biomarker of omega-3 polyunsaturated fatty acid content in the retina has been previously identified, which if lowered may be a risk factor for age-related macular degeneration. A low level could also help to identify patients who would best respond to supplementation. A publication has been submitted and a patent has been filed for this biomarker. The objective of this project is to confirm the relationship between this biomarker and the presence of age-related macular degeneration. The analysis will be refined by correlating the discriminating character of the biomarker with factors that may influence the intestinal metabolism of dietary lipids and their bioavailability in the blood. For this purpose, the status of the subjects with regard to their intestinal flora (microbiota) will be evaluated. The relationship between lipid metabolism, microbiota and age-related macular degeneration should also provide a better understanding of the pathophysiological mechanisms that link diet, lipid metabolism and age-related macular degeneration.

Enrollment

205 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subject who has provided written informed consent for participation in the study and genetic analyses
Subject aged 50 years or older
Subject with exudative AMD or
Subject with macular disorder requiring cataract surgery

Exclusion criteria

Person not affiliated to the national health insurance system
Protected adults (curatorship, guardianship)
Persons deprived of their liberty by judicial or administrative decision
Adult unable to express consent
Subject who has already participated in the study
Subject with pre-existing maculopathy not labelled AMD
Subject refusing blood sample
Subject with diabetes
Subject on antibiotics or having had an antibiotic treatment in the last 3 months
Subject with a BMI < 18.5 or > 30 kg/m2
Subject with extreme eating habits (veganism, bulimia, anorexia)
Subject currently on a diet with avoidance of certain types of food or a low-calorie diet
Subject with an inflammatory disease (especially digestive disease)
Subject having undergone bariatric surgery
Subject having digestive tract malformations