Adherence to Lifestyle Changes for Age-related Macular Degeneration

Last updated: February 19, 2024
Sponsor: Erasmus Medical Center
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Aging

Macular Degeneration

Geographic Atrophy

Treatment

Risk profiling

Coaching

Standard lifestyle recommendations + dietary supplementation

Clinical Study ID

NCT05667441
NL65052.078.18
MEC-2018-063
  • Ages 55-85
  • All Genders

Study Summary

The AMD-Life study investigates which strategies (personalized risk-profiling including genetic testing and/or coaching) motivate AMD patients to change their lifestyle.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Early/Intermediate AMD or unilateral late AMD with minimal vision 0.8

Exclusion

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 themacula
  • Persons who are illiterate and have no independent trusted person with them to explainthe informed consent form.
  • Persons diagnosed with liver and kidney insufficiency.

Study Design

Total Participants: 150
Treatment Group(s): 3
Primary Treatment: Risk profiling
Phase:
Study Start date:
August 01, 2021
Estimated Completion Date:
August 01, 2025

Study 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.

Connect with a study center

  • Erasmus Medical Center

    Rotterdam,
    Netherlands

    Site Not Available

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