Age-Related Macular Degeneration
Conditions
Keywords
Age-Related Macular Degeneration, Lifestyle, Lifestyle change, Genetic testing, Personalized risk-profiling, Gut microbiome, Coaching
Brief summary
The AMD-Life study investigates which strategies (personalized risk-profiling including genetic testing and/or coaching) motivate AMD patients to change their lifestyle.
Detailed description
Age-related macular degeneration is a frequent eye disease in the elderly affecting the center of retina, i.e., the macula. Despite current treatments for the wet form of this disease, it is still the most frequent cause of blindness in the Western world. The disease is the result of the interplay between genetic and environmental factors such as smoking, unhealthy diet, and lack of physical activity. The current clinical recommendations are aimed towards these lifestyle factors: a healthy diet, no smoking, regular physical exercise, and use of antioxidant supplementation. Although assumed to be low by clinicians as they feel patients find it difficult to actually alter their lifestyle, the adherence and feasibility to these recommendations in clinical ophthalmology practice is unclear. Individualizing the patients' risk of blindness and lifestyle changes, as well as coaching may positively influence adherence strategies. This pilot study aims to gain knowledge and experience in a relatively small study comparing adherence to these strategies through a healthier lifestyle. Additionally, the trial investigates blood and gut microbiome biomarkers: which molecules in blood directly relate to the supplemented nutrients as well as those related to the pathogenesis of AMD, and which biomarkers in blood and eye best correlate with supplement intake and lifestyle.
Interventions
COMBINATION_PRODUCTStandard lifestyle recommendations + dietary supplementation
refrain from smoking; perform physical exercise regularly; increase the intake of dietary food groups such as green leafy vegetables, fruits, and fatty fish and recommendations for supplementation with antioxidants according an established formula
COMBINATION_PRODUCTRisk profiling
Personalized risk profiling for lifestyle and genetics.
BEHAVIORALCoaching
Coaching
Sponsors
CORR foundation
Erasmus Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Open label, randomized, clinical trial with 3 arms. Total study duration 2 years: intervention period for 1 year and a follow-up period of 1 year with no intervention for all study arms.
Eligibility
Sex/Gender
ALL
Age
55 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Early/Intermediate AMD or unilateral late AMD with minimal vision 0.8
Exclusion criteria
* Participation in other intervention studies for AMD * Living in retirement homes (difficulty in implementation of diet) * Diagnosis of dementia (because of unreliable dietary recall) * Persons with macular pathology other than AMD hindering appropriate grading of the macula * Persons who are illiterate and have no independent trusted person with them to explain the informed consent form. * Persons diagnosed with liver and kidney insufficiency.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in lifestyle score | 0 and 12 months: intervention phase | Change in lifestyle as measured by online questionnaires, scale from 0-13 in which 13 represents a healthy lifestyle |
Countries
Netherlands
Outcome results
None listed