Age Related Macular DegenerationProject AMDNCT04739319
Project AMD: Comprehensive Characterisation of Age-Related Macular Degeneration and Its Progression
An observational study of Age Related Macular Degeneration and Geographic Atrophy, run by Center for Eye Research Australia at 1 site in Australia.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Age Related Macular Degeneration, Geographic Atrophy, AMD
- What is being tested?
- N/A Observational study
- How many people
- 2,500 participants
- Where
- 1 siteAustralia
- Study dates
- 2 Feb 2021to Nov 2040
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 18 years of age or older; and
- 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
Who cannot join
- ocular or systemic conditions other than AMD that could compromise retinal assessment or assessment of AMD and its progression; or
- any participant with any mental or physical impairment that prevents them from signing an informed consent form or participating in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
Centre for Eye Research Australia
East Melbourne, Victoria, 3002
Carly Parfett, +61 3 9929 8263, cera-rgo@lists.unimelb.edu.au
Raja Choudhury, +61 3 9929 8417, cera-rgo@lists.unimelb.edu.au
About this study
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.
- Conditions
- Age Related Macular Degeneration, Geographic Atrophy, AMD, Age-related Macular Degeneration
- Being tested
- N/A Observational study
- Keywords
- Age Related Macular Degeneration, Geographic Atrophy, Drusen, Macular disease
- Medical subject headings
- Macular Degeneration, Geographic Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N/A Observational studyOther
N/A Observational study
| Study group | Role | What they receive |
|---|---|---|
| Age-Related Macular Degeneration | Participants with Age-Related Macular Degeneration Receives: Other: N/A Observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 20 years
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.
Measured: Up to 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2021
- Study start2 Feb 2021
- Primary completionNov 2040 (estimated)
- Study completionNov 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age Related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Center for Eye Research Australia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04739319
- Sponsor's protocol ID
- CenterERA
- Acronym
- Project AMD
- Status last verified
- Feb 2024
- First submitted
- 1 Feb 2021
- Last updated
- 9 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD at the discretion of the Principal Investigator in a de-identified format
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project AMD: Comprehensive Characterisation of Age-Related Macular Degeneration and Its Progression
- ClinicalTrials.gov ID
- NCT04739319
- Acronym / sponsor ID
- Project AMD / CenterERA
- Conditions
- Age Related Macular Degeneration, Geographic Atrophy, AMD, Age-related Macular Degeneration
- Keywords
- Age Related Macular Degeneration, Geographic Atrophy, Drusen, Macular disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Center for Eye Research AustraliaUniversity, hospital or other
- Study start
- 2 Feb 2021 (actual)
- Primary completion
- Nov 2040 (estimated)
- Study completion
- Nov 2040 (estimated)
- First posted
- 4 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Age-Related Macular Degeneration | – | Other: N/A Observational studyParticipants with Age-Related Macular Degeneration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 18 years of age or older; and
- 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
Key exclusion criteria (2 listed)
- ocular or systemic conditions other than AMD that could compromise retinal assessment or assessment of AMD and its progression; or
- any participant with any mental or physical impairment that prevents them from signing an informed consent form or participating in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N/A Observational studyN/A Observational study | Other | Age-Related Macular Degeneration |
Primary outcome
Investigate the underlying aetiology of Age-Related Macular Degeneration
Time frame: 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.
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All collected IPD at the discretion of the Principal Investigator in a de-identified format
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Centre for Eye Research Australia
East Melbourne, Australia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Age Related Macular Degeneration and Geographic Atrophy, run by Center for Eye Research Australia at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigate the underlying aetiology of Age-Related Macular Degeneration (time frame: Up to 20 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2024.