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NCT05667441 Clinical Trial

Adherence to Lifestyle Changes for Age-related Macular Degeneration

Age-Related Macular Degeneration Clinical Trial

— AMD-Life  

Official title:
Adherence to Lifestyle Changes for Age-related Macular Degeneration

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05667441
Other study ID # NL65052.078.18
Secondary ID MEC-2018-063
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date August 1, 2021
Est. completion date August 1, 2025

Study information
Verified date February 2024
Source Erasmus Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 150
Est. completion date August 1, 2025
Est. primary completion date August 1, 2025
Accepts healthy volunteers No
Gender All
Age group 55 Years to 85 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Combination Product:
• Standard lifestyle recommendations + dietary supplementation
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
Personalized risk profiling for lifestyle and genetics.
Behavioral:
• Coaching
Coaching

Locations
Country Name City State
Netherlands Erasmus Medical Center Rotterdam

Sponsors (2)
Lead Sponsor Collaborator
Erasmus Medical Center CORR foundation

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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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