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OpenTrials
Completed

NCT Number: NCT05667441

Adherence to Lifestyle Changes for Age-related Macular Degeneration

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

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Key information

Age range

55 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erasmus Medical Center

Rotterdam, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Risk profiling

Combination Product

Personalized risk profiling for lifestyle and genetics.

coaching

Behavioral

Coaching

Primary outcomes

  1. Change in lifestyle score

    Time frame: 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

  2. Change in lifestyle score

    Time frame: 12 and 24 months: follow-up phase

    Change in lifestyle as measured by online questionnaires, scale from 0-13 in which 13 represents a healthy lifestyle

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Collaborators

  • CORR foundation

Registry information

Acronym: AMD-Life

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Dec 28, 2022
Registry last updated
Sep 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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