Cerulea Clinical Trials

Clinical Trials

HONU

A Multicenter, Prospective, Observational Study of the Progression of Intermediate Age-Related Macular Degeneration. This trial is operated by the Centre for Eye Research Australia

Overview

Age-related macular degeneration (AMD) is a progressively degenerative condition that can lead to severe central vision loss in its advanced stage. There are currently no approved treatment options for the late ‘dry’ stage of AMD know as geographic atrophy (GA).

The purpose of this observational study is to gain a better understanding of how AMD progresses from the early stages into more advanced stages of the disease.  This knowledge may assist development of future treatments that could be given to people with early stages of AMD before they experience these irreversible changes to their vision.

Treatments that may effectively slow or prevent the progression to advanced AMD are urgently needed. However, because of the slowly progressive nature of this disease, conducting a clinical trial to evaluate treatment effects remains a considerable challenge as such trials need either large numbers of participants or a long timeframe to see significant changes in the AMD stage.

With advances in imaging technology, we can now identify very small changes to the structure of the macula. These changes may indicate that AMD progression is underway well before any change to the vision is noticed.  Understanding which changes are important in the disease process may help us to predict which AMD eyes are likely to progress at a faster rate.  These ‘high risk’ eyes are the ones which may help us better answer whether a new treatment in a clinical trial is effective, as the time to conduct such a trial to answer this question would be reduced.

The objective of this observational study is to further characterise early imaging changes in the macula to find which are important markers of risk of AMD progression.  It will also investigate which genetic, and/or ocular and blood biomarkers may predict AMD disease progression.  Answering these questions will help identify fast-progressing patients, in order to design feasible interventional clinical trials in the future.

People in Australia between 50 and 95 years of age with AMD in both eyes may qualify to participate in this study.

All participants will be required to attend a screening visit to have their eligibility for the study assessed. This is an observational study– no intervention to the eye will be performed.

Participants will attend CERA for a study visit every 12 weeks for a period of 3 years.

Referrals from healthcare practitioners of suitable patients are welcome.

  • Principal Investigator
Professor Robyn Guymer AM

Learn more

View this study at ClinicalTrials.gov

This database listing provides more detailed information about this study.