Project AMD: Comprehensive Characterisation of Age-Related Macular Degeneration and Its Progression
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCenter for Eye Research Australia
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
18 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
Disqualifiers
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.
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
N/A Observational study
Other interventionN/A Observational study
Treatment groups
2,500 Participants
are divided into 1 treatment groupGroup A: Age-Related Macular Degeneration1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Up to 20 years2
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.
Time frame
Up to 20 yearsSponsors and contacts
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Source ClinicalTrials.gov