Project AMD: Comprehensive Characterisation of Age-Related Macular Degeneration and Its Progression
Project AMD
1 other identifier
observational
2,500
1 country
1
Brief Summary
Age-related macular degeneration (AMD) is the leading cause of irreversible vision loss worldwide, and nearly two million Australians have some signs of AMD. This proposed project is a prospective, observational study that seeks to to understand the underlying aetiology of AMD, factors associated with differences between age-related macular degeneration (AMD) phenotypes or severities, or between AMD and healthy individuals. It also seeks to understand the natural history of AMD progression and the factors associated with the rate of progression. In this project, the disease phenotype, genotype and severity and rate of progression will be determined based on non-invasive clinical imaging or functional assessment of the retina, from obtaining biological samples from the participants, or from patient-reported outcomes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2021
Longer than P75 for all trials
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
February 1, 2021
CompletedStudy Start
First participant enrolled
February 2, 2021
CompletedFirst Posted
Study publicly available on registry
February 4, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2040
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2040
February 9, 2024
February 1, 2024
19.8 years
February 1, 2021
February 7, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Investigate the underlying aetiology of Age-Related Macular Degeneration
The first aim of this project is to comprehensively investigate the underlying aetiology of AMD, characterise the AMD phenotype by understanding the differences between those with AMD and healthy individuals.
Up to 20 years
Characterise the natural history of Age-Related Macular Degeneration and factors associated with its rate of progression.
The second aim of this project is to characterise the natural history of AMD and factors associated with its rate of progression. These aims will be achieved by using performing imaging and functional assessment of the retina, characterisation of the genetic, systemic and environmental factors, and by obtaining patient-reported outcomes.
Up to 20 years
Study Arms (1)
Age-Related Macular Degeneration
Participants with Age-Related Macular Degeneration
Interventions
Eligibility Criteria
People in Australia aged 18 years or older with AMD or healthy controls, willing and able to provide informed consent, and willing to accept the study requirements.
You may qualify if:
- years of age or older; and
- either AMD (defined as having at least a medium druse \>63 um), or having eyes with normal ageing changes (including small drusen ≤63 um) or no abnormalities as control participants
You may not qualify if:
- ocular or systemic conditions other than AMD that could compromise retinal assessment or assessment of AMD and its progression; or
- any participant with any mental or physical impairment that prevents them from signing an informed consent form or participating in this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre for Eye Research Australia
East Melbourne, Victoria, 3002, Australia
Related Links
Biospecimen
Blood, saliva, urine or tear samples will be obtained, on selected participants, to obtain genetic information and systematic markers.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 1, 2021
First Posted
February 4, 2021
Study Start
February 2, 2021
Primary Completion (Estimated)
November 1, 2040
Study Completion (Estimated)
November 1, 2040
Last Updated
February 9, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will share
All collected IPD at the discretion of the Principal Investigator in a de-identified format