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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04739319
Other study ID # CenterERA
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 2, 2021
Est. completion date November 2040

Study information

Verified date February 2024
Source Center for Eye Research Australia
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 2500
Est. completion date November 2040
Est. primary completion date November 2040
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

Other:
N/A Observational study
N/A Observational study

Locations

Country Name City State
Australia Centre for Eye Research Australia East Melbourne Victoria

Sponsors (1)

Lead Sponsor Collaborator
Center for Eye Research Australia

Country where clinical trial is conducted

Australia, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Up to 20 years
Primary 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. Up to 20 years
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