Clinical trial NCT05667441: Adherence to Lifestyle Changes for Age-related Macular Degeneration
Official title: Adherence to Lifestyle Changes for Age-related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Age-Related Macular Degeneration
Keywords: Age-Related Macular Degeneration
Lifestyle
Lifestyle change
Genetic testing
Personalized risk-profiling
Gut microbiome
Coaching
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: CORR foundation
First posted: 2022-12-28
Enrollment: 150
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open label, randomized, clinical trial with 3 arms. Total study duration 2 years: intervention period for 1 year and a follow-up period of 1 year with no intervention for all study arms.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in lifestyle score
timeFrame: 0 and 12 months: intervention phase
measure: Change in lifestyle score
timeFrame: 12 and 24 months: follow-up phase
Secondary outcomes:
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
Study officials:
affiliation: Erasmus Medical Center
name: C.C.W. Klaver, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: