Adherence to Lifestyle Changes for Age-related Macular Degeneration

Not Applicable

Active, not recruiting

• Conditions: Age-Related Macular Degeneration

• Registration Number: NCT05667441
• Lead Sponsor: Erasmus Medical Center

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.

Study Timeline

• Study Start: 2021-08-01
• Study First Submitted: 2022-11-21
• Study First Submitted QC: 2022-12-19
• Study First Posted: 2022-12-28
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-19
• Last Update Posted: 2024-02-20
• Primary Completion: 2025-08-01
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in lifestyle score	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

Trial Locations

Locations (1)

Erasmus Medical Center; 🇳🇱 Rotterdam, Netherlands