Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04739319




Registration number
NCT04739319
Ethics application status
Date submitted
1/02/2021
Date registered
4/02/2021
Date last updated
9/02/2024

Titles & IDs
Public title
Project AMD: Comprehensive Characterisation of Age-Related Macular Degeneration and Its Progression
Scientific title
Project AMD: Comprehensive Characterisation of Age-Related Macular Degeneration and Its Progression
Secondary ID [1] 0 0
CenterERA
Universal Trial Number (UTN)
Trial acronym
Project AMD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Age Related Macular Degeneration 0 0
Geographic Atrophy 0 0
AMD 0 0
Age-related Macular Degeneration 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - N/A Observational study

Age-Related Macular Degeneration - Participants with Age-Related Macular Degeneration


Other interventions: N/A Observational study
N/A Observational study
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Investigate the underlying aetiology of Age-Related Macular Degeneration
Timepoint [1] 0 0
Up to 20 years
Primary outcome [2] 0 0
Characterise the natural history of Age-Related Macular Degeneration and factors associated with its rate of progression.
Timepoint [2] 0 0
Up to 20 years

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/02/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/11/2040
Actual
Sample size
Target
2500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Centre for Eye Research Australia - East Melbourne
Recruitment postcode(s) [1] 0 0
3002 - East Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Center for Eye Research Australia
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT04739319
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04739319