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

Recruiting

• Conditions: Age-related Macular Degeneration; Age Related Macular Degeneration; Geographic Atrophy; AMD
• Interventions: Other: N/A Observational study

• Registration Number: NCT04739319
• Lead Sponsor: Center for Eye Research Australia

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-01
• Study First Submitted QC: 2021-02-01
• Study Start: 2021-02-02
• Study First Posted: 2021-02-04
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-07
• Last Update Posted: 2024-02-09
• Primary Completion: 2040-11
• Study Completion: 2040-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2500

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Age-Related Macular Degeneration	N/A Observational study	Participants with Age-Related Macular Degeneration

Primary Outcome Measures

Name	Time	Method
Investigate the underlying aetiology of Age-Related Macular Degeneration	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.
Characterise the natural history of Age-Related Macular Degeneration and factors associated with its rate of progression.	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.

Trial Locations

Locations (1)

Centre for Eye Research Australia; 🇦🇺 East Melbourne, Victoria, Australia