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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04739319
Acronym
Project AMD
Enrollment
2500
Registered
2021-02-04
Start date
2021-02-02
Completion date
2040-11-30
Last updated
2024-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Age-related Macular Degeneration, Age Related Macular Degeneration, AMD, Geographic Atrophy

Keywords

Age Related Macular Degeneration, Geographic Atrophy, Drusen, Macular disease

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.

Interventions

OTHERN/A Observational study

N/A Observational study

Sponsors

Center for Eye Research Australia
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

1. 18 years of age or older; and 2. 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

1. ocular or systemic conditions other than AMD that could compromise retinal assessment or assessment of AMD and its progression; or 2. any participant with any mental or physical impairment that prevents them from signing an informed consent form or participating in this study.

Design outcomes

Primary

MeasureTime frameDescription
Investigate the underlying aetiology of Age-Related Macular DegenerationUp to 20 yearsThe 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.Up to 20 yearsThe 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.

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026