The TArgeting Metabolic INsufficiency in Glaucoma with nicotinamide (TAMING) trial is a world-first randomised-controlled clinical trial to be conducted in partnership with Glaucoma Australia and the Centre for Eye Research Australia.
Glaucoma affects the health and function of nerve cells at the back of the eye leading to irreversible vision loss. Whilst all our treatments are targeted towards lowering eye pressure, many patients continue to progress towards vision loss. New treatments such as nicotinamide, a form of vitamin B3, that can directly enhance the survival of nerve cells in the eye and assist them in functioning properly can transform patient management and improve quality of life. Our previous research has shown that nicotinamide may play an important role in protecting against the nerve damage that leads to blindness in glaucoma. This was the first clinical trial to show that high daily doses of nicotinamide can lead to early and significant improvement in visual function of people with glaucoma – and that nicotinamide has potential as a clinical supplement to support patients who are receiving glaucoma treatment. Nicotinamide has the distinct advantage of being a commercially available supplement meaning that if shown to be useful, it can be immediately implemented into clinical care for glaucoma.
Building upon our earlier work, we devised the TAMING trial, which aims to determine whether daily treatment with high-dose nicotinamide is useful in slowing the progression of glaucoma over a two-year period. We are grateful to be working with Glaucoma Australia on this landmark study to determine whether nicotinamide should be utilised in glaucoma management.
Since late 2020, we have been in discussions with local and international manufacturers of nicotinamide and placebo tablets for clinical trial use. From this, we have partnered with a global manufacturer with exceptional experience to supply our Australian and international trial sites. Together, we have worked to develop a new nicotinamide tablet to be used in the clinical trial. This will allow for an improved dosing schedule and was developed following feedback from our patients in the first study. We have designed a comprehensive clinical protocol that will not only look at changes to vision, but also assess changes to quality of life, and include blood sampling to look for genetic and metabolic clues in how a person responds to taking nicotinamide.
With the announcement of the support from Glaucoma Australia, we have received significant interest from the public and have had a surge of applications to our clinical trial registry to be considered for the trial. Anyone who wants to be considered for this, or any other glaucoma trial at CERA, can register their interest on the CERA website.
We have also leveraged the support from Glaucoma Australia to apply for nationally competitive grants so we can expand the number of trial sites across Australia and recruit greater numbers of patients. This will increase access to the trial to more Australians living across the country and increase the impact of our study.
Currently, we are finalising the logistics of the supply of the tablets to be used in the trial, and despite delays due to COVID, we are on track to recruit our first participants in the next couple of months.
We believe nicotinamide could potentially be an important complement to existing glaucoma treatments – like adding oil to a car engine to allow it to run smoothly, nicotinamide could be used to protect cells from further injury and help the cells that have been affected by glaucoma work better.
•Dr Flora Hui is a Research Fellow and clinician scientist at the Centre for Eye Research Australia. Her work is part of an extensive glaucoma research program at the Centre for Eye Research Australia.