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Clinical Trials/NCT04739319
NCT04739319
Recruiting
Not Applicable

Project AMD: Comprehensive Characterisation of Age-Related Macular Degeneration and Its Progression

Center for Eye Research Australia1 site in 1 country2,500 target enrollmentFebruary 2, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Age Related Macular Degeneration
Sponsor
Center for Eye Research Australia
Enrollment
2500
Locations
1
Primary Endpoint
Investigate the underlying aetiology of Age-Related Macular Degeneration
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2, 2021
End Date
November 2040
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Center for Eye Research Australia
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Investigate the underlying aetiology of Age-Related Macular Degeneration

Time Frame: Up to 20 years

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.

Characterise the natural history of Age-Related Macular Degeneration and factors associated with its rate of progression.

Time Frame: Up to 20 years

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.

Study Sites (1)

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