Adherence to Lifestyle Changes for Age-related Macular Degeneration (AMD-Life)

Erasmus University

Status: Completed

Conditions: Age-Related Macular Degeneration

Treatments: Combination Product: Standard lifestyle recommendations + dietary supplementation; Behavioral: Coaching; Combination Product: Risk profiling

Study type: Interventional

Funder types: Other

Identifiers

NCT05667441

MEC-2018-063 (Other Identifier)

NL65052.078.18

Details and patient eligibility

About

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

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 55 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

150 participants in 3 patient groups

Standard recommendations

Active Comparator group

Description:

The first group (n=50) will receive standard care recommendations (according to Netherlands Scientific Society of Ophthalmology 2014, 'Richtlijn Leeftijdsgebonden Maculadegeneratie;): 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.

Treatment:

Combination Product: Standard lifestyle recommendations + dietary supplementation

Standard recommendations + Risk profiling

Active Comparator group

Description:

The second group (n=50) receives standard care plus personalized risk profiling. A risk scoring based on currently available literature for lifestyle and genetic risk will be used to determine personalized risks of conversion to late AMD. Individuals will be informed about their own risk profile and a personalized strategy will be communicated.

Treatment:

Combination Product: Risk profiling

Combination Product: Standard lifestyle recommendations + dietary supplementation

Standard recommendations + Risk profiling + Additional coaching

Active Comparator group

Description:

The third group (n=50) receives standard care (see 1); personalized risk profiling (see 2); and coaching. A coach will employ behavioral change techniques (BCT) to enhance adherence using motivational interviews, feedback on behavior; and focus on the advantages of following recommendations.

Treatment:

Combination Product: Risk profiling

Behavioral: Coaching

Combination Product: Standard lifestyle recommendations + dietary supplementation