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| ID | Type | Description | Link |
|---|---|---|---|
| MEC-2018-063 | Other Identifier | METC Erasmus MC |
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| Name | Class |
|---|---|
| CORR foundation | UNKNOWN |
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The AMD-Life study investigates which strategies (personalized risk-profiling including genetic testing and/or coaching) motivate AMD patients to change their lifestyle.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard recommendations | Active Comparator | The first group (n=50) will receive standard care recommendations (according to Netherlands Scientific Society of Ophthalmology 2014, 'Richtlijn Leeftijdsgebonden Maculadegeneratie;): 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. |
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| Standard recommendations + Risk profiling | Active Comparator | The second group (n=50) receives standard care plus personalized risk profiling. A risk scoring based on currently available literature for lifestyle and genetic risk will be used to determine personalized risks of conversion to late AMD. Individuals will be informed about their own risk profile and a personalized strategy will be communicated. |
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| Standard recommendations + Risk profiling + Additional coaching | Active Comparator | The third group (n=50) receives standard care (see 1); personalized risk profiling (see 2); and coaching. A coach will employ behavioral change techniques (BCT) to enhance adherence using motivational interviews, feedback on behavior; and focus on the advantages of following recommendations. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard lifestyle recommendations + dietary supplementation | Combination Product | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in lifestyle score | Change in lifestyle as measured by online questionnaires, scale from 0-13 in which 13 represents a healthy lifestyle | 0 and 12 months: intervention phase |
| Change in lifestyle score | Change in lifestyle as measured by online questionnaires, scale from 0-13 in which 13 represents a healthy lifestyle | 12 and 24 months: follow-up phase |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| C.C.W. Klaver, Prof. Dr. | Erasmus Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erasmus Medical Center | Rotterdam | Netherlands |
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| Label | URL |
|---|---|
| AMD-Life website with information for potential participants | View source |
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| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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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.
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| Risk profiling | Combination Product | Personalized risk profiling for lifestyle and genetics. |
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| Coaching | Behavioral | Coaching |
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