Age-Related Macular DegenerationAMD-LifeNCT05667441
Adherence to Lifestyle Changes for Age-related Macular Degeneration
A study testing Standard lifestyle recommendations + dietary supplementation, Risk profiling and Coaching in people with Age-Related Macular Degeneration, run by Erasmus Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Age-Related Macular Degeneration
- What is being tested?
- Standard lifestyle recommendations + dietary supplementation, Risk profiling and Coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Aug 2021to 14 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Early/Intermediate AMD or unilateral late AMD with minimal vision 0.8
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Age-Related Macular Degeneration
- Being tested
- Standard lifestyle recommendations + dietary supplementation, Risk profiling, Coaching
- Keywords
- Age-Related Macular Degeneration, Lifestyle, Lifestyle change, Genetic testing, Personalized risk-profiling, Gut microbiome, Coaching
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard lifestyle recommendations + dietary supplementationCombination product
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 profilingCombination product
Personalized risk profiling for lifestyle and genetics.
CoachingBehavioural
Coaching
| Study group | Role | What they receive |
|---|---|---|
| Standard recommendations | Active comparator | 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. Receives: Combination Product: Standard lifestyle recommendations + dietary supplementation |
| Standard recommendations + Risk profiling | Active comparator | 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. Receives: Combination Product: Standard lifestyle recommendations + dietary supplementation; Combination Product: Risk profiling |
| Standard recommendations + Risk profiling + Additional coaching | Active comparator | 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. Receives: Combination Product: Standard lifestyle recommendations + dietary supplementation; Combination Product: Risk profiling; Behavioral: Coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in lifestyle score
Change in lifestyle as measured by online questionnaires, scale from 0-13 in which 13 represents a healthy lifestyle
Measured: 0 and 12 months: intervention phase
Change in lifestyle score
Change in lifestyle as measured by online questionnaires, scale from 0-13 in which 13 represents a healthy lifestyle
Measured: 12 and 24 months: follow-up phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2022
- Study start1 Aug 2021
- Primary completion14 Jul 2025
- Study completion14 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-Related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- CORR foundation
- Responsible party
- Principal investigator, Caroline C.W. Klaver, MD, Erasmus Medical Center
- Investigators
- C.C.W. Klaver, Prof. Dr., Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05667441
- Sponsor's protocol ID
- NL65052.078.18
- Other IDs
- MEC-2018-063
- Acronym
- AMD-Life
- Status last verified
- Sep 2025
- First submitted
- 21 Nov 2022
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence to Lifestyle Changes for Age-related Macular Degeneration
- ClinicalTrials.gov ID
- NCT05667441
- Acronym / sponsor ID
- AMD-Life / NL65052.078.18
- Conditions
- Age-Related Macular Degeneration
- Keywords
- Age-Related Macular Degeneration, Lifestyle, Lifestyle change, Genetic testing, Personalized risk-profiling, Gut microbiome, Coaching
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- CORR foundation
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 14 Jul 2025 (actual)
- Study completion
- 14 Jul 2025 (actual)
- First posted
- 28 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Standard recommendations | Active comparator | Combination Product: Standard lifestyle recommendations + dietary supplementationThe 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. |
| Standard recommendations + Risk profiling | Active comparator | Combination Product: Standard lifestyle recommendations + dietary supplementation, Combination Product: Risk profilingThe 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. |
| Standard recommendations + Risk profiling + Additional coaching | Active comparator | Combination Product: Standard lifestyle recommendations + dietary supplementation, Combination Product: Risk profiling, Behavioral: CoachingThe 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. |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Early/Intermediate AMD or unilateral late AMD with minimal vision 0.8
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard 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 product | Standard recommendations, Standard recommendations + Risk profiling, Standard recommendations + Risk profiling + Additional coaching |
| Risk profilingPersonalized risk profiling for lifestyle and genetics. | Combination product | Standard recommendations + Risk profiling, Standard recommendations + Risk profiling + Additional coaching |
| CoachingCoaching | Behavioural | Standard recommendations + Risk profiling + Additional coaching |
Primary outcome
Change in lifestyle score
Time frame: 0 and 12 months: intervention phase
Change in lifestyle as measured by online questionnaires, scale from 0-13 in which 13 represents a healthy lifestyle
Change in lifestyle score
Time frame: 12 and 24 months: follow-up phase
Change in lifestyle as measured by online questionnaires, scale from 0-13 in which 13 represents a healthy lifestyle
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
- AMD-Life website with information for potential participantsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
C.C.W. Klaver, Prof. Dr. principal investigator
Erasmus Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard lifestyle recommendations + dietary supplementation, Risk profiling and Coaching in people with Age-Related Macular Degeneration, run by Erasmus Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in lifestyle score (time frame: 0 and 12 months: intervention phase). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2025.