Clinical Trials Directory

Trials / Completed

CompletedNCT05667441

Adherence to Lifestyle Changes for Age-related Macular Degeneration

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
150 (actual)
Sponsor
Erasmus Medical Center · Academic / Other
Sex
All
Age
55 Years – 85 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
COMBINATION_PRODUCTStandard lifestyle recommendations + dietary supplementationrefrain 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 profilingPersonalized risk profiling for lifestyle and genetics.
BEHAVIORALCoachingCoaching

Timeline

Start date
2021-08-01
Primary completion
2025-07-14
Completion
2025-07-14
First posted
2022-12-28
Last updated
2025-09-11

Locations

1 site across 1 country: Netherlands

Source: ClinicalTrials.gov record NCT05667441. Inclusion in this directory is not an endorsement.