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CompletedNCT05667441AMD-LifeUpdated Sep 11, 2025

Adherence to Lifestyle Changes for Age-related Macular Degeneration

An interventional study of Standard lifestyle recommendations + dietary supplementation and Risk profiling in Age-Related Macular Degeneration, sponsored by Erasmus Medical Center. Completed at 1 site in Netherlands. Open to participants aged 55 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-09-11.

Sponsored by Erasmus Medical Center · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 1 year 3 months after the study started (first participant enrolled Aug 2021, registered Nov 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
55 Years to 85 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Age-Related Macular Degeneration

Keywords

  • Age-Related Macular Degeneration
  • Lifestyle
  • Lifestyle change
  • Genetic testing
  • Personalized risk-profiling
  • Gut microbiome
  • Coaching
03

In context

Macular Degeneration

1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.

This study's enrollment of 150 is above the median of 51 across 985 interventional studies indexed under Macular Degeneration.

Browse Macular Degeneration studies →

Lead sponsor

Erasmus Medical Center is the lead sponsor of 466 studies on the registry; 179 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Early/Intermediate AMD or unilateral late AMD with minimal vision 0.8

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
150 participants (actual)

Study arms

  • Active comparator
    Standard recommendations

    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.

    Combination Product: Standard lifestyle recommendations + dietary supplementation

  • Active comparator
    Standard recommendations + Risk profiling

    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.

    Combination Product: Standard lifestyle recommendations + dietary supplementation · Combination Product: Risk profiling

  • Active comparator
    Standard recommendations + Risk profiling + Additional coaching

    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.

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

Interventions

  • Combination productStandard 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

  • Combination productRisk profiling

    Personalized risk profiling for lifestyle and genetics.

  • BehavioralCoaching

    Coaching

06

What researchers measure

Primary outcomes

  1. Change in lifestyle score

    Change in lifestyle as measured by online questionnaires, scale from 0-13 in which 13 represents a healthy lifestyle

    Time frame: 0 and 12 months: intervention phase

  2. Change in lifestyle score

    Change in lifestyle as measured by online questionnaires, scale from 0-13 in which 13 represents a healthy lifestyle

    Time frame: 12 and 24 months: follow-up phase

07

Study locations

1 site
  • Erasmus Medical Center
    Rotterdam, Netherlands
08

References and documents

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05667441
Lead sponsor
Erasmus Medical Center
Collaborators
CORR foundation
Responsible party
Caroline C.W. Klaver, MD (Prof. dr. C.C.W. Klaver, Erasmus Medical Center) — Principal investigator
First posted
Dec 28, 2022
Start date
Aug 1, 2021
Primary completion
Jul 14, 2025
Completion
Jul 14, 2025
Last update
Sep 11, 2025

Study contacts

C.C.W. Klaver, Prof. Dr.
principal investigator · Erasmus Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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