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Check My Macula Check My Macula Join the Community Join the Community Order Free Information Order Free Information Call our helpline at 1800111709 Helpline
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  • Macular Disease
    • Macular Degeneration
      • About Macular Degeneration
      • Check My Macula
      • What Happens?
      • Risk Factors
      • Prevention
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      • Diagnosis
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      • Charles Bonnet Syndrome
      • Cataracts and Macular Degeneration
      • Frequently Asked Questions
    • Diabetic Retinopathy
      • About Diabetic Retinopathy
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      • What Happens?
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    • Low Vision
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    • Other Macular Diseases
      • Best Disease
      • Macular Hole
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      • Anti-VEGF injections for macular disease
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Menu
  • My Cart
    • Language
      • English
      • Arabic
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      • Italian
      • Portuguese
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    • Home
    • Macular Disease
      • Macular Degeneration
        • About Macular Degeneration
        • Check My Macula
        • What Happens?
        • Risk Factors
        • Prevention
        • Detection
        • Diagnosis
        • Treatment
        • Charles Bonnet Syndrome
        • Cataracts and Macular Degeneration
        • Frequently Asked Questions
      • Diabetic Retinopathy
        • About Diabetic Retinopathy
        • About Diabetes
        • What Happens?
        • Risk Factors
        • Prevention
        • Detection
        • Diagnosis
        • Treatment
        • Frequently Asked Questions
      • Low Vision
        • Living with Low Vision
        • Carer and Family
        • Aids and Technology
        • Slips, Trips and Falls
        • Legal blindness
      • Other Macular Diseases
        • Best Disease
        • Macular Hole
        • Macular Pucker
        • Macular Telangiectasia
        • Myopic Macular Degeneration
        • Retinal Detachment
        • Retinitis Pigmentosa
        • Retinal Vein Occlusion
        • Stargardt Disease
        • Central Serous Chorioretinopathy (CSC)
        • Posterior Vitreous Detachment and Floaters
        • Vitreomacular Traction Syndrome
      • Visit Eye Health Professional
        • Eye Injection Costs and Rebates
      • Macular Disease
        • Anti-VEGF injections for macular disease
    • Research
      • Research Grants Program
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        • Apply for the MDFA Research Grants Program
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Research

  • Research Grants Program
    • Research Grants Awarded
      • 2019 Research Grants
      • 2017 Research Grants
      • 2015 Research Grants
      • 2013 Research Grants
      • 2012 Research Grants
      • 2011 Research Grants
    • Research Grant Recipients
      • Professor Alex Brown
      • Dr Audra Shadforth
      • Dr Zhichao Wu
      • Professor Mark Gillies
      • Associate Professor Bamini Gopinath
      • Professor Robyn Guymer
      • Associate Professor Damien Harkin
      • Dr Isabelle Jalbert
      • Professor Steven Krilis
      • Dr Gerald Liew
      • Associate Professor Chi Luu
      • Professor Paul Mitchell
      • Associate Professor Alice Pébay
      • Dr Liubov Robman
    • Research Grants Panel
    • Apply for the MDFA Research Grants Program
  • Support Research
  • Latest Research
    • Research News
      • Scientists test potential drug developed in Australia to treat common causes of blindness: pre-clinical study
      • “Eye in a dish” reveals importance of gene variation for AMD
      • Implanted drug 'reservoir' safely reduces injections for people with macular degeneration
      • New study indicates regular egg consumption could reduce risk of developing age-related macular degeneration (AMD)
      • Vegetables, fruit and fish can help reduce risk of age-related macular degeneration (AMD)
      • Inability to recognise faces impairs social life: study
      • Study suggests AMD as a biomarker of frailty and ageing
      • Anti-VEGF Treatment NOT Linked to Increased Risk of Stroke, Myocardial Infarction or Death
      • Focusing on the fovea
    • MDFA Research
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      • Macular Degeneration
        • Key Research
        • Other Research
      • Diabetic Retinopathy
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    • Understanding Research
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  • Research Updates
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      • Archive: Annual Research Update 2017
    • Weekly Research Updates for Professionals
      • 2020 Research Updates
      • 2019 Research News
        • MD Research News – Issue 422 – 16 May 2019
        • MD Research News – Issue 423 – 24 May 2019
        • MD Research News – Issue 424 – 7 June 2019
        • MD Research News – Issue 425 – 14 June 2019
        • MD Research News – Issue 426 – 21 June 2019
        • MD Research News – Issue 427 – 27 June 2019
        • MD Research News – Issue 428 – 4 July 2019
        • MD Research News – Issue 429 – 18 July 2019
      • Archive 2018 Research News
      • Subscribe to Weekly Research Update
  • Research studies
    • Research participants needed in the Canberra region who enjoy art and have vision loss
    • Volunteer participants with age-related macular degeneration who have difficulty seeing faces require
    • Volunteer participants sought for age-related macular degeneration study
    • Retinitis pigmentosa
    • PhD opportunities in eye health
    • NSW-based carers required for research project

Understanding Research

 

Researchers around the world are currently working on macular diseases to find reasons for these diseases and the answers needed. There are many ongoing clinical trials and the Foundation is proud of the many brilliant and dedicated Australian researchers who form part of this international team.

Since 2011 Macular Disease Foundation Australia has committed $4.1 million to its Research Grants Program which directly supports the work of world-leading Australian researchers who aim to reduce the impact and incidence of macular degeneration and ultimately, find a cure.

You can support this research by making a donation to Macular Disease Foundation Australia today.

Clinical trials 

Clinical trials are studies in humans, which aim to find a better way to manage a particular disease. They aim to establish: correct dosage, safety, efficacy (how well it works), interactions with other drugs, comparisons to other treatments, cost effectiveness and use in specific medical situations. Trials are designed in a way that minimise the possibility of bias or incorrect conclusions. 

Medical Research Phases

There are several medical research phases that must be completed before a new drug can be registered by Australia’s Therapeutic Goods Administration. Note that the duration of each phase is an approximate one and can be much longer than stated below.

Research Phase

Patients Studied

What Studied

Duration

Discovery and development

Usually laboratory work

What causes a disease; identify targets (eg identify a ‘key’ that turns off an unwanted process)

Many years

Pre-clinical

Animals or cell cultures

Proof of principle, safety in animals, safe starting dose, toxicity

4 years

Phase 1

20 to 80 volunteers

Safety and dosing

1 – 2 years

Phase 2

100 to 300 volunteers with disease

Initial efficacy, dosing, larger scale safety

2 years

Phase 3

500 to 3000 volunteers with disease

Detailed efficacy, safety, comparison to other treatments

3 years

Registration and reimbursement

 

Regulators review studies and detailed manufacturing dossier to decide if treatment should be registered and subsidised

18-24 months

Phase 4

Consenting patients using the test treatment once launched

Long term safety and efficacy

Ongoing


Drug approval for use in Australia for safety and efficacy

Once a manufacturer has completed the pre-clinical and phase 1 to 3 clinical studies for a new treatment, the Therapeutic Goods Administration (TGA) reviews vast amounts of data on how the research was conducted, and its findings. The TGA also reviews information about the manufacturing process to ensure that drugs are manufactured to specification. Only after the TGA is satisfied that the treatment has an acceptable safety profile and is effective, can it be registered for use in Australia.

Making drugs affordable 

Following registration, the Pharmaceutical Benefits Advisory Committee (PBAC) reviews additional data regarding the safety, efficacy (effectiveness) and cost-effectiveness of a new treatment to decide whether it should receive a government subsidy and be placed onto the Pharmaceutical Benefits Scheme (PBS).

Once a treatment is placed on the PBS, the patient will only pay a part of the actual cost of the drug, with the rest being subsidised by the taxpayer.

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