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RecruitingNCT04739319Project AMDUpdated Feb 9, 2024

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

An observational study in Age Related Macular Degeneration, Geographic Atrophy and AMD, sponsored by Center for Eye Research Australia. Recruiting at 1 site in Australia. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-09.

Sponsored by Center for Eye Research Australia · Observational

From the registry’s dates

  • Started Feb 2021; still recruiting 5 years 8 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,500
Ages
18 Years and older
Sex
All
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Study 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.

02

Conditions studied

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

Keywords

  • Age Related Macular Degeneration
  • Geographic Atrophy
  • Drusen
  • Macular disease
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In context

Macular Degeneration

1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.

This study's planned enrollment of 2,500 is above the median of 106 across 421 observational studies indexed under Macular Degeneration.

Browse Macular Degeneration studies →

Lead sponsor

Center for Eye Research Australia is the lead sponsor of 12 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

People in Australia aged 18 years or older with AMD or healthy controls, willing and able to provide informed consent, and willing to accept the study requirements.

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

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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,500 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Age-Related Macular Degeneration

    Participants with Age-Related Macular Degeneration

    Other: N/A Observational study

Interventions

  • OtherN/A Observational study

    N/A Observational study

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to 20 years

  2. 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.

    Time frame: Up to 20 years

07

Study locations

1 of 1 sites recruiting
08

References and documents

Related links

Individual participant data

Plan to share: Yes — All collected IPD at the discretion of the Principal Investigator in a de-identified format

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04739319
Lead sponsor
Center for Eye Research Australia
Responsible party
Sponsor
First posted
Feb 4, 2021
Start date
Feb 2, 2021
Primary completion
Nov 2040 (estimated)
Completion
Nov 2040 (estimated)
Last update
Feb 9, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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