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Recruiting NCT04739319

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

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

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: N/A Observational study.
Who it may be relevant to
Registry conditions: Age Related Macular Degeneration, Geographic Atrophy, AMD, Age-related Macular Degeneration. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Australia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

  • Other N/A Observational study
    N/A Observational study

Primary outcome measures

  • Investigate the underlying aetiology of Age-Related Macular Degeneration [Time frame: Up to 20 years]
  • Characterise the natural history of Age-Related Macular Degeneration and factors associated with its rate of progression. [Time frame: Up to 20 years]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Australia · 1 center
  • Centre for Eye Research Australia — East Melbourne

Identifiers

NCT: NCT04739319 · CenterERA

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗