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

February 7, 2024 updated by: Center for Eye Research Australia
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

2500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 20 years
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.
Up to 20 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Center for Eye Research Australia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 2, 2021

Primary Completion (Estimated)

November 1, 2040

Study Completion (Estimated)

November 1, 2040

Study Registration Dates

First Submitted

February 1, 2021

First Submitted That Met QC Criteria

February 1, 2021

First Posted (Actual)

February 4, 2021

Study Record Updates

Last Update Posted (Estimated)

February 9, 2024

Last Update Submitted That Met QC Criteria

February 7, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CenterERA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All collected IPD at the discretion of the Principal Investigator in a de-identified format

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Age-related Macular Degeneration

Clinical Trials on N/A Observational study

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe