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

Age-related Macular Degeneration Clinical Trial

— Project AMD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04739319
• Other study ID #: CenterERA
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

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

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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