Can the Risk for AMD be Modulated?
AMD_LifeGene
Diet, Lifestyle, Systemic Medication and Genetics: Can the Risk for AMD be Modulated?
1 other identifier
interventional
1,800
1 country
1
Brief Summary
The goal of this Cross-sectional, interventional study is to learn about whether different risk factors, as Mediterranean diet, lifestyle and concomitant medication can modulate the risk imprinted by genetics in Age-related macular degeneration (AMD). The main question it aims to answer is: How the genetic risk interacts with environmental and lifestyle factors, especially Mediterranean diet and chronic medication, in order to assess how this interplay protects or presents higher risk for the establishment or the progression of AMD. Participants: Vital Signs will be measured; Medical History, Demographics, Nutritional/lifestyle habits and Family History of AMD will be recorded; Ophthalmological Examination will be performed Genetic analysis will be performed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 22, 2022
CompletedFirst Posted
Study publicly available on registry
February 21, 2023
CompletedStudy Start
First participant enrolled
June 26, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 6, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 12, 2028
ExpectedSeptember 23, 2025
May 1, 2025
1.6 years
December 22, 2022
September 22, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Development of AMD
Assessment of the presence or absence of AMD.
18 months
Secondary Outcomes (4)
To evaluate how diet, physical activity level, body mass index, smoking, and chronic medication correlate with the development of AMD, determining if they are protective or risk factors.
18 months
Genetically characterize the population and the presence of common and rare variants associated with AMD.
18 months
The 10-year incidence of AMD in the inland population.
18 months
Identify genotypic-phenotypic correlations.
18 months
Study Arms (1)
Epidemiologic study
OTHERThis is an epidemiologic study. No arms are considered.
Interventions
The study intervention consists of a blood draw for genetic analysis.
Eligibility Criteria
You may qualify if:
- Adult subjects residing in the Lousã region who participated in the epidemiologic study;
- Subjects capable of understanding the information about the study and to give their written informed consent to enter the study;
- Subjects willing and able to comply with the study procedures.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
AIBILI-CEC (AIBILI- Clinical Trials Centre)
Coimbra, 3000-548, Portugal
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 22, 2022
First Posted
February 21, 2023
Study Start
June 26, 2023
Primary Completion
February 6, 2025
Study Completion (Estimated)
January 12, 2028
Last Updated
September 23, 2025
Record last verified: 2025-05