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
1 other identifier
observational
205
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 11, 2020
CompletedFirst Submitted
Initial submission to the registry
February 18, 2020
CompletedFirst Posted
Study publicly available on registry
February 20, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 21, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 9, 2020
CompletedNovember 24, 2020
November 1, 2020
6 months
February 18, 2020
November 23, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Retinal Omega-3 polyunsaturated fatty acid levels
at inclusion
Secondary Outcomes (1)
Intestinal bacterial population levels
at inclusion
Study Arms (2)
case
patient with age-related exudative macular degeneration
control
Patient with no macular disorder and in need of cataract surgery
Interventions
dosage of omega 3 polyunsaturated fatty acids, search for age-related macular degeneration susceptibility genese
Eligibility Criteria
patients coming for consultation in the ophthalmology department
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU dijon Bourgogne
Dijon, 21079, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 18, 2020
First Posted
February 20, 2020
Study Start
February 11, 2020
Primary Completion
August 21, 2020
Study Completion
September 9, 2020
Last Updated
November 24, 2020
Record last verified: 2020-11