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Macular Research Projects

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Current Research

Clinical Trials (currently recruiting)

International studies with a CERA study site (not recruiting)

Publications 2012-2017

View publications list for Macular Research Team

Current Research

ASPREE-AMD – A sub-study of the randomised controlled trial ‘Aspirin in Reducing Events in the Elderly’ (ASPREE)

Low dose aspirin is widely used in older adults for prevention of cardiovascular disease. Aspirin may also impact on the course of age-related macular degeneration (AMD). The international clinical trial ASPREE (AU-USA, N=19,114) examines whether the potential benefits of aspirin in preventing cardiovascular disease, cancers and dementia outweigh the risks and extends the length of disability-free survival in people 65+ years. Additional information can be found on the website of the ASPREE trial.

The Australian-based collaborated (Monash University and Centre for Eye Research Australia) ASPREE-AMD sub-study (N=5000) is a 5-year follow up randomised controlled trial, which examines the effect of long-term intake of low dose aspirin on the incidence and progression of AMD in people 70 years or older. This sub-study, primarily funded by the Australian National Health and Medical Research Council for the period 2013-2017, received substantial further funding from the National Eye Institute of National Institutes of Health and additional financial and equipment support from Monash University and Centre for Eye Research Australia.

The Monash component of the ASPREE-AMD study is led by Professor John McNeil, MBBS, PhD, FRACP, of Monash University on Melbourne. The CERA component of the study is led by Professor Robyn Guymer, MBBS, PhD, FRANZCO, of CERA and University of Melbourne.

Monash University conducts recruitment, general health assessment and retinal photography. The assessment of AMD status from the retinal images is performed by the Macular Research team at CERA. Additional information can be found on the website of ASPREE-AMD sub-study.

Demographics, baseline characteristics, health status changes, developed co-morbidities, blood samples for biomarker and genetic tests are collected. AMD status is determined on the retinal images from the baseline (2010-2014) and after 3 and 5 years of follow up. Median age of the participants at baseline was 73.5 years (range 70-94 years). Multiple high resolution retinal photo cameras operate at the stationary sites and in the mobile units, conducting retinal photography in 22 recruitment centres and multiple test sites nearby. Although a majority of participants (69%) were recruited from cities, 31% were photographed in more remote regional centres and rural areas, providing good representation across the population.

Given the frequency of aspirin usage in the elderly and the prevalence of AMD in our society, the findings of this study are expected to be of significant clinical and public interest. Recruitment for the ASPREE-AMD trial finished in 2014, the current stage of 3-year follow up will be finished at the beginning of 2018, the 5-year follow up data collection will be finished in the mid-2020. The final trial results are expected to be published in 2020-2021.

Applications for remote vision monitoring

The changes that happen in AMD sometimes occur without warning and the earlier these changes are detected, the better the prognosis for vision. It is current practice that patients with AMD are given a paper grid known as an Amsler chart and asked to look for new distortion or blur. However, we are currently investigating a better way patients might monitor their vision. We have been working in collaboration with Prof Algis Vingrys (University of Melbourne) and Dr George Kong (Royal Victorian Eye and Ear Hospital) to develop vision monitoring applications for tablet devices. Already we have found that many patients use these devices at home. Our aim is to be able to remotely monitor a patient’s progression, improvement or change in visual function, thus detecting complications early and ensuring treatment is started in a timely manner.

Dark adaptation in early stages of AMD

Many people with early stages of AMD complain of adjusting to darkness after seeing a bright light although their vision is still perfect. The dark adaptation response is managed by rod photoreceptors in the retina. This study aims to determine whether measurement of rod photoreceptors function (dark adaptation) will be a functional endpoint to monitor the progression of AMD before late-stage AMD develops. Measurement of dark adaptation at multiple locations in the retina will use a novel Australian made Dark-Adapted Chromatic (DAC) perimeter. Participants will have baseline examination and will be followed up for every 6 months for 1 year. Dark adaptation will be compared at each time point and correlated with macular structure using multimodal imaging devices.

Epidemiology of AMD

This research investigates the impact of modifiable risk factors, such diet and lifestyle, on AMD. We also examine the relationship between AMD and other health problems such as cardiovascular disease and inflammatory disorders. These insights improve our understanding of how macular degeneration develops, and will hopefully result in people being able to lower their risk of being affected by AMD.

Laser intervention in early age-related macular degeneration (LEAD) Trial

CERA is the coordinating centre and lead investigative site for a world first, multi-centered, randomised, controlled trial of a nanosecond laser intervention in high-risk, early AMD. The study is an investigator-initiated study and is being conducted in collaboration with Ellex R&D Pty Ltd, an Australian manufacturer of laser systems for eye surgery. The laser has been specially developed to treat retinal diseases including early AMD.

Recruitment for the LEAD trial finished in early 2015 and results are expected to be reported by the end of 2018.

OCT-A Zeiss ARI network

OCT-A is new technology that allows us to take images of the retinal blood vessel network, down through to the choroid (a vascular layer under the retina) without the need for contrast such as fluorescence.

The OCT-A tracks the motion of the red blood cells through b-Scans being repeatedly performed in the same location of the retina. This is then converted into a map of the retinal blood vessel network.

We have joined the ARI network, which is a collaboration with international sites all using the Zeiss OCT-A Angioplex 9000. This machine is the newest in OCT-A and is using swept-source technology.

We will be sharing images with other sites, to learn how to interpret the angiography images and to discover the vascular changes in retinal diseases.

Phagocytosis

In collaboration with Professor Erica Fletcher (University of Melbourne) and Dr Ben Gu (Florey Institute)

AMD is characterized by the accumulation of debris in the retina, in the form of drusen and a thickened Bruch’s membrane, yet the exact cause of this accumulation is not known. The retinal pigment epithelium (RPE), a layer in the retina, plays a key role in clearing debris that accumulates, a process called phagocytosis. However, as we age, the RPE doesn’t function as well so we rely on phagocytic specific cells (monocytes and macrophages) to help clear away the debris.

We hypothesise that this second phagocytic function (monocytes and macrophages) is not occurring in the AMD patients and therefore we have an accumulation of debris in the retina.

We are able to measure this phagocytic ability with a blood test, which is sent off (on the same day as collection) to be analysed at the Florey institute.

Currently we are collecting peripheral blood samples (blood test) in AMD patients and aged matched healthy controls to measure their phagocytic ability.

Retinitis pigmentosa and bionic eye research

Retinitis pigmentosa (RP) is a genetically inherited disease that causes loss of the photoreceptors (cells that detect light) in the retina at the back of the eye and eventual blindness (tunnel vision at first followed by loss of central vision). It is the leading cause of irreversible blindness in working age people in the Western world, affecting over 2 million people. Our team is collaborating with several other leading Australian research institutes, including the Bionics Institute in Melbourne, the Lions Eye Institute in Perth, and Bionic Vision Technologies (BVT), to conduct studies into both the natural progression of retinal changes in RP and develop a retinal prosthesis (bionic eye) for vision restoration purposes. We also have strong international research collaborations, including Harvard University and Schepens Research Institute.

Since 2010, we have been recruiting patients with RP for our natural history progression study and we are currently collecting the 5-year data, which includes advanced retinal imaging and eye movement tracking techniques. This work will provide further information about the progression of retinal and blood flow changes in the back of the eye in RP, as well as information about how eyes with low vision track objects, which can both assist clinicians working with RP patients and feed into the bionic eye technology development. For the past decade, we have been involved with early phase design and preclinical studies of the bionic eye devices developed as part of the Bionic Vision Australia consortium, and in 2012-14 we conducted the first-in-human clinical trial of the prototype retinal prosthesis in three patients with RP. The trial was a great success, with all patients able to perceive artificial vision and no unexpected serious adverse events. Since 2012, have been part of the multidisciplinary team designing, and testing a second-generation retinal prosthesis and we hope to lead a clinical trial with this new and improved bionic eye device soon.

Structural and functional biomarkers for AMD

Currently, there is a lack of sensitive biomarkers for monitoring AMD progression from the early stages to a late AMD form with irreversible vision loss. This project investigates robust surrogate markers of disease progression and late AMD development, using multimodal imaging and electrophysiological and psychophysical testing modalities. The retinal structure and function are studied using state-of-the-art equipment including colour fundus photography, spectral-domain and swept-source optical coherence tomography (OCT), OCT angiography, fundus autofluorescence, multifocal electroretinography, microperimetry and dark-adapted chromatic perimetry. The structural and functional biomarkers identified from this project will allow novel interventions aimed at slowing disease progression to be tested more efficiently and greater expediency.

 

Clinical trials (currently recruiting)

The MacTel Study: A Natural History Observation and Registry Study of Macular Telangectasia Type 2

The purpose of this study is to enrol people with MacTel Type 2 and their affected family members into a registry to learn more about the disease. The register may be used in the future to identify persons eligible to participate in treatment trials.

 Contact: Melinda Cain Study Coordinator Ph: 03 9929 8388 Email: mcain@unimelb.edu.au

NEI ARIS study – Longitudinal study of Early and Reticular Pseudodrusen

The ARIS aims to further characterise Reticular Pseudo Drusen (RPD) and to further understand the progression of early AMD to late stage disease.

Inclusion criteria:

Cohort 1- Early AMD: Medium drusen 63-125 microns both eyes.

Cohort 2- RPD: At least 1 eye with RPD with no more than 1 large drusen (>125 microns) in either eye.

Cohort 3- Controls: no drusen >63 microns, no RPD or pigmentary change both eyes.

Contact: Emily Caruso Study Coordinator Ph: 9929 8113 Email: emily.caruso@unimelb.edu.au

SWAGGER and IMPACT studies – Non-Exudative Age-Related Macular Degeneration Imaged with Swept Source Optical Coherence Tomography

The Swagger and Impact studies aim to monitor patients with the Swept Source OCT-A. The OCT-A enables images to be taken of the retinal blood vessel network down through to the choroid without the need for contrast.

Inclusion Criteria:

Impact: Intermediate AMD (drusen only) in both eyes, in the absence of Geographic Atrophy (GA) (dry AMD) and Non-Geographic Atrophy or Intermediate AMD in one eye and CNV(wet AMD) in the other.

Swagger: Geographic Atrophy or non-Geographic Atrophy secondary to AMD. GA size to be at least 125 microns (the size of 1 large drusen) and no greater than 7 Disc areas (17mm2)

Contact: Emily Caruso Study Coordinator Ph: 9929 8113 Email: emily.caruso@unimelb.edu.au

 

International studies with a CERA study site (not recruiting)

 

Macular Telangiectasia (MacTel)

Idiopathic Juxtafoveal Macular Telangiectasia (MacTel) is an uncommon eye condition generally affecting people over 50. It is a disorder of the blood vessels which supply the macula. They become dilated and incompetent and while MacTel does not usually cause total blindness, it commonly causes loss of central vision, which is required for reading and driving vision, over a period of 10-20 years.

MacTel CNTF2

This international study of a Ciliary Neurotropic Factor (CNTF) implant in the eye is the first treatment study in Australia for Macular Telangiectasia. These participants will have safety follow up visits for a further 4 years.

Results of this study should be announced in 2018.

Proxima A (Roche)

Proxima A is a Natural History study looking at the progression of bilateral geographic atrophy (GA) (dry AMD) in AMD patients. This study looks at the progression of GA with Multi modal imaging, which includes OCT, Infra red photos, Auto florescence photos, colour fundus photos and microperimetry.

Proxima B

Proxima B is looking at the progression of GA in AMD patients. These participants have unilateral GA with the other eye either having CNV (wet AMD) or Drusen (early AMD). The progression of GA is monitored with Multi modal imaging which includes, OCT, Infra red photos, Auto florescence photos and colour fundus photos.