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Clinical Trials

Our patients benefit by receiving the most advanced treatment available anywhere in the world. In many cases, patients with specific eye disorders are given access to new treatments before they are available to the general public.

The Lions Eye Institute (LEI) offers the unique blend of having scientists working in close association with the clinicians to bring laboratory generated ideas and techniques to the level where they can be of benefit to people suffering some of the most common blinding eye conditions in the world.

The clinicians at the LEI have a major commitment to research and teaching. This is one of the LEI’s major strengths, enabling new developments and treatments for these blinding eye conditions to be not only developed further but also made available to patients attending our clinical facility.

Our Clinical Trials

SEQUOIA Trial

Safety and Efficacy of Abicipar Pegol (AGN-150998) in Patients with Neovascular Age-related Macular Degeneration.

Patients are randomised to 12, 8 or 4 weekly treatment.

Trial registry no: NCT02462486

A multi-site exploration of the experience of neo-vascular AMD – Flinders University / Lions Eye Institute

Understanding the influence of uncertainty in people’s experience of age-related macular degeneration.
Participants are invited to describe their experience of treatment in wet AMD.

Trial registry no: No NCT/ACTRN

HAWK Study – Alcon Research Ltd.

A Two-year, Randomized, Double-masked, Multicentre, Three-Arm Study Comparing the Efficacy and Safety of RTH258 versus Aflibercept in Subjects with Neovascular Age-Related Macular Degeneration.

Participants are randomised to 3 monthly or 2 monthly treatment.

Trial registry no: NCT02307682

RIVAL Study – Novartis

Development of new geographic atrophy in patients with neovascular (wet) age-related macular degeneration: A comparison of ranibizumab and aflibercept.

FLUID Study – Novartis

A Phase IV, randomised, controlled, single masked study investigating the efficacy and safety of ranibizumab “inject and extend” using an intensive retinal fluid retreatment regimen compared to a relaxed retinal fluid retreatment regimen in patients with wet age-related macular degeneration (AMD).

Trial Register Number: NCT01972789

AMD – LEI / Avalanche Biotechnologies Inc

A Phase I/II Controlled Dose-Escalating Trial to Establish the Baseline Safety and Efficacy of a Single Subretinal Injection of rAAV.sFlt-1 into Eyes of Patients with Exudative Age-Related Macular Degeneration (AMD).

Trial Register Number: NCT01494805

Publication Links: http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(15)00345-1/abstract

ESBA1008 Microvolume Study – Alcon

Prospective, Two Cohort, Single-Masked Study to Evaluate the Effect of ESBA1008.

Applied by Microvolume Injection or Infusion in Subjects with Exudative Age-Related Macular Degeneration.

Trial Register Number: NCT01849692

LUMINOUS – Novartis

Study to Observe the Effectiveness and Safety of Ranibizumab Through Individualized Patient Treatment and Associated Outcomes.

Trial Register Number: NCT01318941

PROXIMA A – Roche

A Multicentre, Prospective Epidemiologic Study of the Progression of Geographic Atrophy Secondary to Age-Related Macular Degeneration.

Participants are observed once every 6 months with no treatment.

Trial Registry Number: NCT02479386

PROXIMA B TRIAL

A Multicentre, prospective epidemiologic study of the progression of geographic atrophy secondary to age-related macular degeneration.

Participants are observed once every 6 months with no treatment.

Trial registry no: NCT02399072

BEACON Study – Allergan

Safety and Efficacy of Brimonidine Posterior Segment Drug Delivery System in Patients with Geographic Atrophy Secondary to Age-related Macular Degeneration.

Participants are randomised to 3 monthly treatment or no treatment.

Trial Register Number: NCT02087085

SPECTRI Study – Roche Ltd.

A Phase III, Multicentre, Randomized, Double-Masked, Sham-Controlled Study to Assess the Efficacy and Safety of Lampalizumab Administered Intravitreally to Patients with Geographic Atrophy Secondary to Age-Related Macular Degeneration.

Participants are randomised to 4 or 6 weekly treatment or no treatment.

Trial Registry Number: NCT02247531

FILLY Study – Apellis Pharmaceuticals Inc.

A Phase II, Multicentre, Randomized, Single-Masked, Sham-Controlled Study of Safety, Tolerability and Evidence of Activity of Intravitreal APL-2 Therapy in Patients with Geographic Atrophy (GA).

Participants are randomised to 1 or 2 monthly treatment or no treatment.

Trial Registry Number: NCT02503332

LEAD Study – CERA / NH&MRC / Ellex

A Multi-Centre, randomised trial into the safety and efficacy of nanosecond microsurgical laser intervention in early age-related macular degeneration.

Natural History Study in Macular Degeneration – LEI

A natural history study for the assessment of visual function measurements in patients with macular degeneration.

T-BRVO Study – LEI/ORIA

The effect of Tenecteplase on intravenous thrombus and retinal blood flow in patients with branch retinal vein occlusion (BRVO).

The Lions Eye Institute is currently seeking patients with a recent branch retinal vein occlusion to participate in a one month study. The T-BRVO study aims to show that an injection of Tenecteplase into the back of the eye (intraocular injection) will reduce the clot in the retinal vein and restore blood flow to the vein. It also aims to show that this treatment will result in improved vision outcomes. Participants will be assigned to receive the Tenecteplase injection or a sham injection one week before starting the current standard treatment of intraocular injections of anti-VEGF.

For further information about the treatment or assessment about eligibility for the study, please contact Lynne Smithies on (08) 9381 0790 or LynneSmithies@lei.org.au

Trial Registry Number: ACTRN12615000185561

L-CVBS Extension Study – LEI

The combination treatment of laser induced chorioretinal venous anastomosis and Lucentis for macula oedema that is secondary to central retinal vein occlusion, compared to the published results of Lucentis treatment only, a phase IV study.

The Lions Eye Institute is seeking patients with recent a central retinal vein occlusion to participate in a 2 year study. The Lucentis-Central Vein Bypass Extension Study (L-CVBS Extension Study) requires monthly visits to the Lions Eye Institute in Nedlands over a 2 year period. It provides participants with a combination treatment of laser bypass (chorioretinal venous anastomosis- L-CRA) and Lucentis injections. The laser bypass treatment was developed at the Lions Eye Institute and the results from our published research show that participants who received this treatment had better and sustained vision than those participants who did not get the laser bypass treatment.  In our current research, we are able to show that participants who receive the combination treatment (laser bypass and Lucentis injections) require fewer injections than participants who receive the Lucentis injections only.  In this study all participants receive the combination treatment. This is a phase IV monitoring study examining the efficacy of the combination treatment in the broader population.

For further information or to be accessed for acceptability for the L-CVBS Extension Study please contact Lynne Smithies on (08) 9381 0790 or LynneSmithies@lei.org.au

Trial Registry Number: ACTRN12615001094561

L-CVBS – LEI / Novartis

A comparison of the number of Lucentis injections(eye injections) required for patients who receive a combination treatment of laser bypass (chorioretinal venous anastomosis) and Lucentis or sham laser bypass and Lucentis for the treatment of macular oedema (swelling at the back of the eye) that has occurred as a result of a central retinal vein occlusion.

Participants are randomised to receiving laser chorioretinal shunt or sham laser prior to routine treatment with Lucentis in central retinal vein occlusion.

Trial Registry Number: ACTRN12612000004864

Genetic and Metabolomic Predictors in Diabetes Study – Medical Research Foundation of Royal Perth Hospital / Lions Eye Institute

Medical Research Foundation, RPH Genetic and metabolomic predictors of outcomes and complications of diabetes.

Participants are invited to donate blood and physical and eye examination.

Trial Registry Number: No NCT/ACTRN

SWITCHDMO study – University of Sydney / NH&MRC

Trial of Switching Between Intravitreal Bevacizumab (Avastin®)& Intravitreal Dexamethasone (Ozurdex™) for Persistent Diabetic Macular Oedema (SwitchDMO)

Trial Registry Number: NCT01787669

BEVORDEX study – University of Sydney / NH&MRC

A Multicentre Randomised Clinical Trial of Intravitreal Bevacizumab (Avastin®) Versus Intravitreal Dexamethasone (Ozurdex™) for Persistent Diabetic Macular Oedema.

Trial Registry Number: NCT01298076

VIVID DME study – Bayer Schering Pharma

A randomized, double-masked, active-controlled phase III study of the efficacy and safety of repeated doses of intravitreal VEGF Trap-Eye in subjects with diabetic macular edema.

Trial Registry Number: NCT01331681

A Multicentre Randomised Clinical Trial of Laser Treatment Plus Intravitreal Triamcinolone for Diabetic Macular Oedema study – University of Sydney

Phase II/III Multicentre Randomised Clinical Trial of Laser Treatment Plus 4 mg Intravitreal Triamcinolone Injection to Reduce Diabetic Macular Oedema.

Trial Registry Number: NCT00148265

The Australian Inherited Retinal Disease Register and DNA Bank – Sir Charles Gairdner Hospital / Retina Australia / Lions Eye Institute

Establishment of a database of clinical, genetic and family history information as well as results from standardised visual electrophysiology and psychophysical tests on subjects suffering from inherited retinal diseases and their family members.

Participants with inherited retinal diseases are asked to donate blood for analysis. See more here: http://www.irdregister.org.au/

Trial Registry number: no ACTRN.

The Western Australian Retinal Degeneration (WARD) Study – Lions Eye Institute / Retina Australia

Characterisation of the clinical features and disease progression of patients with retinal degenerative disease over 5 years and correlation with biomarkers in serum and plasma, DNA and patient specific induced pluripotent stem cell disease modelling.

Participants with inherited retinal diseases are required to have detailed eye assessment once every 6 months for disease monitoring. Blood and skin cells are collected once for disease modelling and development of personalised treatment of retinal degeneration.

Trial registry number: no ACTRN.

No Trials.

Western Australia Eye Protection Study

A number of environmental factors are believed to play a role in the development of myopia, including education. The association between education and myopia may reflect a number of factors such as near work activities and less time spent outdoors, however the causal pathways are not yet fully understood.

We are interested in looking at the educational level of young adults, their time spent outdoors and the link to both of these factors with myopia development.

Participants receive a free comprehensive eye examination and answer questionnaires about general eye health and time spent outdoors. For more information, please contact Lisa on 9381 0707, email lisabooth@lei.org.au or see http://mackeylab.org/eps.

The Western Australian Retinal Degeneration (WARD) Study – Lions Eye Institute / Retina Australia

Characterisation of the clinical features and disease progression of patients with retinal degenerative disease over 5 years and correlation with biomarkers in serum and plasma, DNA and patient specific induced pluripotent stem cell disease modelling.

Participants with inherited retinal diseases are required to have detailed eye assessment once every 6 months for disease monitoring. Blood and skin cells are collected once for disease modelling and development of personalised treatment of retinal degeneration.

Trial registry number: no ACTRN.

No Trials.

Vein Pulsation Study Trial in Glaucoma – NH&MRC/LEI

Additive Effect of Twice Daily Brinzolamide 1% / Brimonidine 0.2% Fixed Dose Combination as an Adjunctive Therapy to a Prostaglandin Analogue.

Participants are invited to have special photograph and recording of artery and vein pressures within the eye.

Trial Registry Number: ACTRN12608000274370

GLH694 Study – Alcon

Additive Effect of Twice Daily Brinzolamide 1% Brimonidine 0.2% Fixed Dose Combination as an Adjunctive Therapy to a Prostaglandin Analogue.

A study to investigate the combined effect of Simbrinza with other eye medication on Glaucoma.

Trial Registry Number: 2015-000736-15

No trials.

No trials.

EYEGUARD-A Study – Servier

A Randomized , Double-masked, Placebo-controlled Study of the Safety and Efficacy of Gevokizumab in the Treatment of Active Non-infectious Intermediate, Posterior, or Pan-Uveitis.

EYEGUARD-C Study – Servier

A Randomized, Double-masked, Placebo-controlled Study of the Safety and Efficacy of Gevokizumab in the Treatment of Subjects with Non-infectious Intermediate, Posterior, or Pan-uveitis Currently Controlled with Systemic Treatment.

EYEGUARD-X Study – Servier

A Randomized , Double-masked, Placebo-controlled Study of the Safety and Efficacy of Gevokizumab in the Treatment of Active Non-infectious Intermediate, Posterior, or Pan-Uveitis.

M11-327 Study – Abbvie (last patient enrolled ……)

A Multicentre Open-Label Study of the Long-Term Safety of the Long-term Safety and Efficacy of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects with Non-infectious Intermediate, Posterior, or Pan-uveitis.

Trial Registry Number: No ACTRN

Development of a Blood Test for Melanoma – Raine Foundation / Lions Eye Institute / Edith Cowan University

A comparison of the levels of immune cells, circulating tumour cells as well as cell free DNA, RNA, proteins and exosomes from patient blood with that of primary or metastatic tumour tissue before and after treatment.

Participants with uveal melanoma are asked to donate blood for analysis before and after treatment.

Trial Registry Number: No ACTRN.

Reduced Dose Radiotherapy for Juxtapapillary Choroidal Melanoma – Peter MacCallum Cancer Centre / RANZCR / Lions Eye Institute

A Pilot Study of Reduced Dose Radiotherapy Delivered In Standard Fractionation to Improve The Therapeutic Index For Stereotactic Treatment Of Juxtapapillary Choroidal Melanoma.

Participants with uveal melanoma at the macula (centre of the retina) are treated with low dose fractionated radiation (60 Gy in 30 fractions and 5 fractions per week) and monitored for 10 years.

Trial Registry Number: ACTRN12614000531617

No trials.

Effect of Hydroxychloroquiune (Plaquenil) on Cone Photoreceptors – Lions Eye Institute / Sir Charles Gairdner Hospital

Cellular imaging of the human retina to investigate the effects of hydroxychloroquiune on cone photoreceptors

Participants undergoing routine electrophysiology monitoring of the effect of hydroxychloroquine (plaquenil) on retina are invited to have detailed retinal imaging to determine if there is reduced cone photoreceptor cell density and function

Trial registry number: no ACTRN

No Trials

Western Australia Eye Protection Study

A number of environmental factors are believed to play a role in the development of myopia, including education. The association between education and myopia may reflect a number of factors such as near work activities and less time spent outdoors, however the causal pathways are not yet fully understood.

We are interested in looking at the educational level of young adults, their time spent outdoors and the link to both of these factors with myopia development.

Participants receive a free comprehensive eye examination and answer questionnaires about general eye health and time spent outdoors. For more information, please contact Lisa on 9381 0707, email lisabooth@lei.org.au or see http://mackeylab.org/eps.

No Trials.

NHOR – Lowy Medical Research Institute

The natural history and registry study.

Participants contact details and medical history are recorded in a registry.

http://www.lmri.net/clinicians/clinical-trials/nhor/

Trial Registry Number: No ACTRN/NCT

NTMT-02 Study – Neurotech Inc. / Lowy Medical Research Institute

A Phase 2 Multicentre Randomized Clinical Trial of Ciliary Neurotrophic Factor (CNTF) for Macular Telangiectasia Type 2.

Trial Registry Number:  NCT01949324

https://clinicaltrials.gov/ct2/show/NCT01949324?term=NCT01949324&rank=1

The MacTel Project – Lowy Medical Research Institute

A natural history study of macular telangiectasia over 5 year follow up.

Publications Link: http://www.lmri.net/about/publications/

Distortion and Scotoma Assessment (DSA) Study – Lions Eye Institute

Validation of new quantitative clinical tests of distortion and scotoma with structure-function correlations.

Participants with distortion in their vision or blind spots in the central visual field are invited to have detailed retinal imaging to determine if there is changes in cone photoreceptor cell density and function.

Trial registry number: no ACTRN

Effect of Hydroxychloroquiune (Plaquenil) on Cone Photoreceptors – Lions Eye Institute / Sir Charles Gairdner Hospital

Cellular imaging of the human retina to investigate the effects of hydroxychloroquiune on cone photoreceptors.

Participants undergoing routine electrophysiology monitoring of the effect of hydroxychloroquine (plaquenil) on retina are invited to have detailed retinal imaging to determine if there is reduced cone photoreceptor cell density and function.

Trial registry number: no ACTRN

A comparative study of Two microperimeters: The Nidek MP1S versus the CentreVue MAIA – Lions Eye Institute

Trial Registry Number: CTN 264/2012

Publication Link: http://www.ncbi.nlm.nih.gov/pubmed/26285157

No Trials.

No Trials.

The Western Australian Retinal Degeneration (WARD) Study – Lions Eye Institute / Retina Australia

Characterisation of the clinical features and disease progression of patients with retinal degenerative disease over 5 years and correlation with biomarkers in serum and plasma, DNA and patient specific induced pluripotent stem cell disease modelling.

Participants with inherited retinal diseases are required to have detailed eye assessment once every 6 months for disease monitoring. Blood and skin cells are collected once for disease modelling and development of personalised treatment of retinal degeneration.

Trial registry number: no ACTRN.

No Trials.

No Trials.

No Trials.

No Trials.

No Trials.

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