Two years of clinical trial magic
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Two years of clinical trial magic
On 20 May Cerulea celebrates two years of bringing transformative treatments to Victorians.
‘Nothing can be done’ used to be the distressing response to many people diagnosed with serious and complex eye conditions. It’s a phrase that Cerulea hopes to see disappear from use.
Biotechnology and pharmaceutical company partners run groundbreaking Phase I-IV trials at the state-of-the-art Cerulea Clinical Trials.
Based at the Royal Victorian Eye and Ear Hospital, the unit features specialised vision lanes, an imaging suite for advanced retinal scanning, laser rooms, dark rooms for adaptation testing, and a reception and lounge designed with low-vision visitors in mind, down to the textures, lighting and customised layouts.
Cerulea has already run trials on some of the most challenging eye health conditions, including:
• An oral tablet for retinitis pigmentosa
• An intravitreal injection – delivered directly into the eye – for uveitis
• A gene therapy trial for autosomal dominant optic atrophy in children and adolescents
• Drug delivery implants for glaucoma, and
• A device using surface microcurrent stimulation to potentially slow age-related macular degeneration.
Chief Medical Officer Professor Lyndell Lim says it is incredibly rewarding to be involved in trials that offer treatment for conditions that previously had none.
“Two recent trials have been completed and their results released,” Professor Lim said.
“The first is a new tablet treatment for retinitis pigmentosa associated with Usher syndrome — a rare genetic disorder — which was found to slow the rate of disease progression, helping preserve sight for longer.
“The other is a new treatment for macular oedema in autoimmune uveitis, where people lose vision from inflammation in the eye.
“Prior treatments were somewhat effective but caused glaucoma and cataract.
“The new treatment has been shown to be effective without these complications.
“Both trials have been groundbreaking and offer new hope for our patients, as they will undoubtedly lead to further treatments and applications in related conditions.”
Chief Executive Officer Dr Michelle Bradney was appointed to the role last year after spending two decades leading pharmaceutical and biotechnology clinical development programs.
She highlights Cerulea’s involvement in a Phase 3 trial for Stargardt disease – a rare inherited condition that causes progressive central vision loss, typically appearing in children or young adults.
“The study treatment is administered in oral tablet form and, if found successful, could be a potential breakthrough as the first effective oral treatment for this condition,” Dr Bradney said.
Cerulea trial participants – aged from 3 to 100 – visit the unit regularly and build strong relationships with study coordinators and ophthalmologists.
Appointments typically involve vision and general health checks, completion of questionnaires, discussions about symptoms and any adverse events, and administration of the study treatment.
“Patients are helping us as much as we are trying to assist them, and we are very grateful,” Dr Bradney said.
“Trials are becoming more focused on quality of life, independence, and real-world outcomes, not just vision measurements on a chart. Scientists, clinicians, and trial teams are listening more closely to the lived experience of people with vision loss, and that is improving both treatments and care.”
Although in its early days, Cerulea has not needed to promote itself to attract partners – pharmaceutical and bio/med-tech companies are coming to Cerulea, drawn by the outstanding reputation of the clinical specialists, researchers, and facilities.
Patients are usually recruited through their own interest or via their specialists, and Cerulea is always looking for more participants.
“At the moment, not enough ophthalmologists are referring patients into trials,” Dr Bradney said.
“When you’re an oncology patient, clinical trials are part of the conversation — but ophthalmology is not quite there yet.”
The team is building referral pathways with ophthalmologists and optometrists across Victoria, establishing patient registries, and exploring satellite and hybrid sites so people in regional areas can access trials without travelling to Melbourne.
Artificial intelligence will also play a role, helping identify eligible patients in clinical databases.
“We are now investigating conditions where we used to say nothing can be done,” Dr Bradney said.
“If we can preserve patients’ vision, that’s huge progress — and that will lead to more patients wanting to participate in clinical trials rather than just accepting their condition.”
