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Currently Recruiting Studies

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Age-Related Macular Degeneration (AMD)

Neovascular AMD

ARIES

Managing Neovascular Age-related Macular Degeneration (nAMD) Over 2 Years With a Treat and Extend (T&E) Regimen of 2 mg Intravitreal Aflibercept – a Randomized, Open-label, Controlled, Phase IV/IIIb Study

This two-year study aims to evaluate the optimal use, efficacy, and safety of a Treat-and-Extend regimen with aflibercept (Eylea) in subjects with neovascular AMD.

Principal Investigator: Dr Suki Sandhu
Study Coordinator: Maria Kolic
More information: ARIES at ClinicalTrials.gov.

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

SEQUOIA

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

This is a two-year study evaluating the safety and efficacy study of abicipar pegol in patients with neo-vascular age-related macular degeneration. Following a loading dose, patients will be randomised to either abicipar pegol eight-weekly, twelve-weekly or ranibizumab (Lucentis) four-weekly.

Principal Investigator: Dr Sanj Wickremasinghe
Study Coordinator: Roberta Cimetta
More information: SEQUOIA at ClinicalTrials.gov.

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

Geographic Atrophy

PROXIMA A

Natural History Geographic Atrophy Study
The primary objective of the study is to generate a better understanding of the variability and dynamic range of visual function tests over time and how these changes correlate with changes in Geographic Atrophy area in patients with Geographic Atrophy (GA) secondary to Aged related Macular Degeneration (AMD). The study includes 10 visits over 48 months (4 years) with one approximately 2-hour appointment every 6 months.

Principal Investigator: Professor Robyn Guymer
Study Coordinator: Emily Caruso
More information: PROXIMA A at ClinicalTrials.gov

To speak to a study coordinator, call 9929 8113 or email: cera-trials@unimelb.edu.au

PROXIMA B

Natural History Geographic Atrophy Study
The primary objective of the study is to generate a better understanding of the variability and dynamic range of visual function tests over time and how these changes correlate with changes in Geographic Atrophy area in patients with Geographic Atrophy (GA) secondary to Aged related Macular Degeneration (AMD). The study includes 12 visits over 68 months (5 years) with one approximately 2-hour appointment every 6 months.

Principal Investigator: Professor Robyn Guymer
Study Coordinator: Emily Caruso
More information: PROXIMA b at ClinicalTrials.gov

To speak to a study coordinator, call 9929 8113 or email: cera-trials@unimelb.edu.au

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

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: cera-trials@unimelb.edu.au

Central Retinal Vein Occlusion

CRVO inject and extend

The efficacy of intravitreal aflibercept given in a treat and extend regime in the treatment of cystoid macular oedema secondary to central retinal vein occlusion

This is a 24-month, uncontrolled, single-centre clinical trial of Aflibercept (Eylea) to treat cystoid macular oedema secondary to CRVO. All patients will receive intravitreal injections of Aflibercept (Eylea) monthly for three months and then following an inject and extend protocol.

This is a proof of concept study to assess the utility of a treat and extend strategy in the treatment of macular oedema associated with CRVO.

Principal Investigator: Dr Sanj Wickremasinghe
Study Coordinator: Thuy Chau
More information: CRVO inject and extend at anzctr.org.au.

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

Uveitis

POINT

Periocular and intravitreal corticosteroids for uveitis macular edema (POINT) trial

This is a six-month study to evaluate the relative efficacy of three commonly utilised regional corticosteroids for the regional treatment of uveitic macular edema: periocular triamcinolone acetonide; intravitreal triamcinolone acetonide; intravitreal dexamethasone implant. The primary efficacy measure will be percent change in central subfield thickness as measured by OCT at 8 weeks.

Principal Investigator: Dr Richard Stawell
Study Coordinator: Thuy Chau
More information: POINT at clinicaltrials.gov.

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

FAST

First-Line Antimetabolites as Steroid-sparing Treatment (FAST) Uveitis Trial

In the First-line Antimetabolites as Steroid-sparing Treatment (FAST) Uveitis Trial, the investigators propose to establish which immunosuppressive therapy, methotrexate or mycophenolate mofetil, is more effective as a first-line, corticosteroid-sparing agent for the treatment of non-infectious uveitis in a randomized, masked, comparative effectiveness trial.

The primary outcome is treatment success assessed at the 6-month visit. If patients are a treatment success, they continue the medication for another 6 months. Patients who are a treatment failure can crossover to the other medication.

Principal Investigator: A/Prof Lyndell Lim
Study Coordinator: Tanya Pejnovic
More information: FAST at clinicaltrials.gov.

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


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