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NCT Number: NCT04739319

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

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.

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Key information

Conditions

Age Related Macular Degeneration AMD Age-Related Macular Degeneration Eye Diseases Geographic Atrophy Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

N/A Observational study

Other

N/A Observational study

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Center for Eye Research Australia

Other

Registry information

Acronym: Project AMD

Important dates

Study start
2021
Primary completion
2040
Study completion
2040
First posted
Feb 4, 2021
Registry last updated
Feb 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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