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

• Sponsor: Center for Eye Research Australia (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04739319
• Collaborator: (none)
• Enrollment: 2,500
• Location: 1
• Anticipated Duration (Months): 236.9
• Patients Per Site Per Month: 10.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Age Related Macular Degeneration; Geographic Atrophy; AMD; Age-related Macular Degeneration	Other: N/A Observational study

Study Design

• Study Type: Observational
• Anticipated Enrollment: 2500 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Project AMD: Comprehensive Characterisation of Age-Related Macular Degeneration and Its Progression
• Actual Study Start Date: Feb 2, 2021
• Anticipated Primary Completion Date: Nov 1, 2040
• Anticipated Study Completion Date: Nov 1, 2040

Arms and Interventions

Arm	Intervention/Treatment
Age-Related Macular Degeneration Participants with Age-Related Macular Degeneration	Other: N/A Observational study; N/A Observational study

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre for Eye Research Australia	East Melbourne	Victoria	Australia	3002

Sponsors and Collaborators

• Center for Eye Research Australia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: Center for Eye Research Australia
• ClinicalTrials.gov Identifier: NCT04739319
• Other Study ID Numbers: CenterERA
• First Posted: Feb 4, 2021
• Last Update Posted: Jul 22, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Center for Eye Research Australia: Age Related Macular Degeneration; Geographic Atrophy; Drusen; Macular disease
• Additional relevant MeSH terms: Macular Degeneration; Geographic Atrophy; Atrophy

Study Results

No Results Posted as of Jul 22, 2022