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Currently Recruiting Studies

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Diabetic Macular Oedema

LADAMO

A Phase IV randomised clinical trial of laser therapy for peripheral retinal ischaemia combined with intravitreal aflibercept (Eylea®) versus intravitreal aflibercept monotherapy for diabetic macular oedema

This is a 24-month phase IV, randomised, prospective, multicentre, clinical trial of laser therapy to areas of peripheral retinal ischaemia combined with intravitreal aflibercept versus intravitreal aflibercept monotherapy. Both arms will have 2mg intravitreal aflibercept according to a treat and extend protocol.

The specific aim of the study is to test whether laser therapy of peripheral retinal ischaemia reduces the overall number of intravitreal aflibercept injections required to control DMO over a 24-month period.

Principal Investigator: Dr Sanj Wickremasinghe
Study Coordinator: Sutha Sanmugasundram
More information:LADAMO at ClinicalTrials.gov.

To speak to a study coordinator, call 9929 8076, or email: cera-trials@unimelb.edu.au

Diabetic Retinopathy

Natural History of Diabetic Retinopathy in Pregnant Women

The primary objective of the study is to investigate how Diabetic Retinopathy is affected during pregnancy and after delivery, and also aims to discover any risk factors, or reasons, that may cause diabetic retinopathy to worsen faster in pregnancy. The study includes 6 visits over 21 months (during pregnancy until a year after delivery) with one approximately 2-hour appointment in each trimester, and 3-month, 6-month, and 12-month post-delivery.

Principal Investigator: A/Professor Lyndell Lim
Study Coordinator: Dr Felicia Widyaputri

To speak to a study coordinator, email: widyaputrif@unimelb.edu.au

Macular Telangiectasia

A Natural History Study of Macular Telangiectasia Type 2.

The Natural History and Registry Study (NHOR) is a world-wide registry of persons with Macular Telangiectasia (MacTel) Type II. Patients are enrolled at an initial visit with a comprehensive eye exam and imaging, and are contacted annually to update contact information. Any persons in the Registry will be informed of new findings about MacTel and clinical trial information.

Principal Investigator: Professor Robyn Guymer
Study Coordinator: Melinda Cain

To speak to a study coordinator, call 9929 8388, or email: mcain@unimelb.edu.au

 

Uveitis

MERIT

Macular Edema Ranibizumab v. Intravitreal anti-inflammatory Therapy Trial

The MERIT Trial was designed to find out which intravitreal therapy offers the best balance of effectiveness and tolerability in treating persistent or recurrent uveitic macular edema in eyes with controlled uveitis but persistent macular edema, specifically by comparing the relative efficacy and safety of intravitreal ranibizumab (Lucentis) and intravitreal methotrexate to intravitreal dexamethasone implant (Ozurdex) for the treatment of persistent /recurrent uveitic macular edema.

Principal Investigator: A/Prof Lyndell Lim
Study Coordinator: Thuy Chau
More information:MERIT at clinicaltrials.gov.

To speak to a study coordinator, call 9929 8076, or email: cera-trials@unimelb.edu.au

Gilead – Filgotinib

A Phase 2, Randomized, Placebo-Controlled Trial Evaluating the Efficacy and Safety of Filgotinib in Subjects with Active Non-Infectious Uveitis

This is a randomized, masked, placebo-controlled Phase II trial in subjects with active non-infectious uveitis despite at least 2 weeks of maintenance therapy with oral prednisolone. The study is designed to demonstrate the efficacy and safety of filgotinib in subjects requiring high dose steroids for active non-infectious uveitis.

Principal Investigator: A/Prof Lyndell Lim
Study Coordinator: Thuy Chau
More information:GS-US-432-4097 at clinicaltrials.gov.

To speak to a study coordinator, call 9929 8076, or email: cera-trials@unimelb.edu.au

 

 

Nonarteritic Anterior Ischaemic Optic Neuropathy (NAION)

QRK207

A Phase 2/3 Randomized, Double-Masked, Sham-Controlled Trial of QPI-1007 Delivered By Single or Multi-Dose Intravitreal Injection(s) to Subjects With Acute Nonarteritic Anterior Ischemic Optic Neuropathy (NAION)

Principal Investigator: Dr Neil Shuey
Study Coordinator: Sutha Sanmugasundram
More information:QRK207 at clinicaltrials.gov.

 

Affiliated Studies

 

The Clinical Trial Research Centre at CERA also provides ophthalmic services and support to external Research Centres conducting trials.

Currently involved trials:

    GS-US-389-2022

A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GS-9688 in Patients with Chronic Hepatitis B

Principal Investigator: Prof Kumar Visvanathan
Affiliation: St Vincent’s Hospital
More information: GS-US-389-2022 at ANZCTR.

 

MIK665

Phase I open label, multi-center study to characterize the safety, tolerability and pharmacokinetics of intravenously administered MIK665, a Mcl-1 inhibitor, in patients with refractory or relapsed lymphoma or multiple myeloma

Principal Investigator: Dr Andrew Lim
Affiliation: Austin Health
More information: MIK665 at clinicaltrials.gov.

 

STARTRK-2

An Open-Label, Multicenter, Global Phase 2 Basket Study of Entrectinib for the Treatment of Patients with Locally Advanced or Metastatic Solid Tumors that Harbor NTRK1/2/3, ROS1, or ALK Gene Rearrangements

Principal Investigator: A/Prof Tom John
Affiliation: Austin Health
More information: STARTRK-2 at clinicaltrials.gov.

 

 


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