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The Clinical Trials Research Centre at CERA is Melbourne-based and is located within a large tertiary referral centre, The Royal Victorian Eye and Ear Hospital (RVEEH). Our trials team of over 40 trial ophthalmologists, orthoptists and scientists have expertise in diseases including: age-related macular degeneration, glaucoma, uveitis, diabetic eye disease, corneal eye disease, retinal disease (retinal vein occlusion), and bionic vision research. We are building an Eye Trials Research Network of private ophthalmology sites to increase our geographic reach and the diversity/severity of diseases that we cover.
We have been involved in over 60 investigator initiated and pharmaceutical or biotech sponsored studies.
- Expert clinical advice from world renown key opinion leaders
- Clinical study expertise from phase I-IV studies and with drug, device and observational studies
- Visual acuity examiner and visual acuity room certification
- Coordination of private eye research study sites
- Biostatisticians specialised in eye research
- ICH-GCP (TransCelerate-accredited) training courses
- Ophthalmic services and support to external Research Centres conducting trials in various phases and disease types
A/Prof Lyndell Lim, Principal Investigator and Consultant Ophthalmologist specialising in Medical Retina and Ocular Inflammatory Diseases, leads the team at the Clinical Trials Research Centre. The Clinical Operations Head, Helen Ormandy PhD, provides a central point of contact for all general sponsor enquiries, including feasibility approaches for new studies. This sponsor liaison provides an intermediary and oversight function during study start-up to ensure efficient site activation and resolution of any issues:
Our research capabilities
Our “Site CV” summarises our capabilities, click here to download.
Eye research clinical methodologies
We are equipped to perform a range of eye research methodologies and surgeries as one of the top five global eye research groups (Clarivate Analytics Web of Science).
Our people resource includes: ophthalmologists, orthoptists, nurses, statisticians and scientists specialised in eye research (Our clinical staff are Board-certified).
Patient examinations and imaging include:
- Refraction and Best Corrected Visual Acuity
- Reading Speed Testing
- Low Luminance Visual Acuity Testing
- Intraocular Pressure
- Colour Vision Testing
- Humphrey Visual Field Testing
- Anterior Segment Imaging
- Physical Examinations (including blood pressure, height, weight, ECG)
- Optical Coherence Tomography Angiography (OCT-A)
- Spectral Domain Optical Coherence Tomography (SD-OCT)
- Fluorescein Angiography and Indocyanine Green Angiography
- Fundus Autofluorescence
- Colour Fundus Photography
- Electroretinogram (ERG)
- Biological Sample Testing
- Dark Adaptation Perimetry
We also have access to the facilities of the Eye and Ear Hospital for additional specialist testing.
Our quality framework
All investigators and study coordinators must hold current TransCelerate-accredited ICH-GCP. Our own standard operating procedures (SOPs) ensure that all staff are equipped to lead and manage clinical studies to ICH-GCP standard and global regulatory standards (IND/FDAs). We can either work with our own SOPs or follow our clients’ SOPs.
In addition to external audits organised by sponsors, internal quality control is also regularly conducted within our Centre, focusing on high-risk studies to ensure constant audit readiness. We have been audited three times by sponsors, mostly recently in November 2016, with minimal findings. We can also monitor, train and certify other eye research sites.
Design through to publication of investigator initiated studies
- Design clinical studies
- Write investigator brochures, study protocols, clinical study reports and manuscripts
- Prepare budgets, manage study finances and agreements
- Train site and study personnel in Good Clinical Practice (GCP)
- Manage investigational product
- Manage all ethics, regulatory and safety submissions and reporting requirements
- Create databases, enter, clean and statistically analyse data
- Manage quality through risk-assessment and management, site monitoring, and by training of our own staff and other sites
High recruitment and generation of quality research data as an individual study site
We have a record of:
- Meeting or exceeding recruitment targets in 87% of all studies
- Successful HREC submissions though a committee who understand the nature of eye research
- Median time to full HREC approval is 2 months
- Fast start-up times to First-Patient-In (FPI) after HREC approval as we prescreen where possible. We recently attained national FPI in the Lampalizumab and BEACON studies.
- Successful audits: our last sponsor audit had no study related findings
- Recruited for landmark eye research studies including:
- Neo-vascular Age-related Macular Degeneration (ANCHOR, EXCITE, SUSTAIN, VIEW II, PIER, MARINA studies)
- Central Retinal Vein Occlusion (GALILEO study)
- Diabetic Macular Oedema (MACUGEN, RESOLVE, RESTORE, VIVID, Posurdex studies)
- Uveitis (VISUAL I, II and III studies)
- Excellent retention rates: in our longest study with a 9-year follow-up, only 9% of patients were lost to follow-up
For a comprehensive list of CERA’s studies: click here.
Management of an eye trials research network
We support a growing network of private practices specialising in eye research. Ophthalmologists collaborating with the Clinical Trials Research Centre can draw on the support of our experienced and mobile study coordinators and medical staff to coordinate and train/certify staff in their private practices.
Our mobile study coordinators can support studies within the Eye Trials Research network from start to finish including:
- Site feasibilities
- HREC, regulatory and safety submissions/reporting
- Contract and budget negotiation, and finance management
- Investigational product management
- Preparation and management of source documents and other study documents
- Patient scheduling
- Data-entry and query resolution
- Quality control including site set-up, monitoring and close-out
- Training and certification of staff in eye exams and ICH GCP.
Sponsors can rely on us to manage the Eye Trials Research Network.
For a detailed description, staff bio-sketches are available: click here.
- Our Head of Clinical Research, Assoc. Prof. Lyndell Lim, the founding ophthalmologist of the Clinical Trials Research Centre, provides clinical oversight
- Our Head of Clinical Operations, Helen Ormandy PhD, has over 20 years of experience in the biotechnology and pharmaceutical industry and provides a central point of contact for operational enquiries and feasibilities
- Our Principal Investigators and Sub-Investigators, ophthalmologists have clinical expertise in: age-related macular degeneration, glaucoma, uveitis, diabetic eye diseases, retinal vascular diseases (e.g. retinal vein occlusion) and bionic vision research
- Our study coordinators are experienced clinical orthoptists and clinical study managers
- Bio-statisticians specialised in eye research
- All staff engaged in clinical studies are trained in ICH GCP (TransCelerate approved course) and we have a dedicated Training Manager on staff
- The Centre for Eye Research Australia also has a scientists and clinicians engaged in translation eye research including preclinical science, genetics and behavioural research
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