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    Fight Retinal Blindness! Registry

    How Professor Mark Gillies’ ever-expanding digital database helps clinicians across the globe.

    FRB! Registry Analysing Real-world Outcomes

    Professor Mark Gillies’ ever-expanding digital database, known as the Fight Retinal Blindness! (FRB!) Registry, assesses how well eye injections work in the real world, helping clinicians deliver the best care to their patients across the globe.

    To date, Prof Gillies has focused on neovascular age related macular degeneration (nAMD) – but this year, the project has expanded to other retinal conditions.

    When vascular endothelial growth factor inhibitors, or anti-VEGF agents, first became available in 2006, clinical trials showed excellent results among patients with nAMD.1,2

    Ophthalmologist Professor Mark Gillies, a University of Sydney Medical School Foundation Fellow and a clinician-scientist who directs the Macular Research Group at the Save Sight Institute at the University of Sydney, decided to examine the efficacy of anti-VEGF therapy in routine clinical practice – in other words, how well this treatment works in the real world, rather than within the ideal standardised conditions of a clinical trial.3

    To do this, he created the FRB! project – a clinical web-based registry that tracks the real-world effectiveness, safety and outcomes of patients treated with various retinal diseases.

    Established in 2007, the project captures data on nAMD as well as choroidal neovascularisation (CNV) other than nAMD, diabetic macular oedema and retinal vein occlusion.

    A research grant from Macular Disease Foundation Australia (MDFA) in 2015 helped Prof Gillies expand his study across the globe, engaging clinicians from South Africa and Switzerland to Italy and India.

    The FRB! Registry now gathers data from more than 500 practitioners spanning 23 countries across Europe, Asia, Africa and the Pacific, including 151 right here in Australia. Each country has its own steering committee that curates their national data, enabling practitioners to track their patients’ outcomes, contribute to their country’s benchmarks and self-audit against their peers.

    Impressively, the FRB! Registry has become one of the world’s leading observational databases and the only system in the world with long-term data on anti-VEGF treatments for macular disease.

    “MDFA funding allowed me to grow the FRB! project into the world’s leading registry of high-quality data on the outcomes of treatment of macular disease and set international benchmarks for how the best outcomes for wet AMD can be achieved in real-word clinical practice,” Prof Gillies said.

    The FRB! Registry Gathers Global Data

    Practitioners in the following countries are now contributing data to the FRB! Registry: Spain (171 practitioners), Australia (151), Netherlands (45), France (36), New Zealand (22), United Kingdom (17), Italy (14), South Africa (13), Belgium (11), Austria (seven), Slovakia (six), Switzerland (four), Fiji (three), Ireland (two), Lebanon (two), Portugal (two), Bosnia and Herzegovina, (one), Germany (one), India (one), Indonesia (one), Serbia (one), Singapore (one), and Slovenia (one).

    Measuring effect on quality of life

    The FRB! project allows clinicians to capture data on dosing regimens, drugs and clinical settings. Additionally, patients can contribute their perceived effect of anti- VEGF therapy on their quality of life.

    The clinician, or their assistant, can enter the data from each visit in less than 15 seconds on any device with a browser. Responses to patient wellbeing questionnaires are also automatically and securely transmitted to the digital database for analysis.

    As well as providing real-world evidence to assess the value of anti-VEGF therapy in whole populations, the registry has more direct implications for clinicians and patients – it provides a concise summary of the treatment journey over time for individual patients to aid practitioners’ decision-making process.

    Clinicians are also able to generate reports summarising outcomes for all their patients to conduct self-audits and compare their performance relative to other clinicians.

    Real world findings

    One of the FRB! project’s most notable real-world clinical findings for the treatment of nAMD came as a result of a head-to-head comparison of the two leading anti-VEGF agents, ranibizumab and aflibercept.

    Despite the original suggestion that aflibercept was stronger and lasted longer than ranibizumab, they were shown to deliver similar outcomes for nAMD.4

    In 2021, Prof Gillies is undertaking a second project that will compare the effectiveness of these two agents for diabetic macular oedema, in which preliminary analysis suggests that aflibercept has the edge over the other drugs. Analysis of threeyear outcomes began in February.

    “We expect to find points of differentiation between the two drugs, which will help clinicians identify the best agent for their specific patient this year,” Prof Gillies said.

    Another important clinical finding was an analysis of treatment patterns and outcomes during the maintenance phase of treatment, during which clinicians attempt to reduce the treatment load for patients.

    In the world’s first analysis of 10-year outcomes of anti-VEGF medications for nAMD, Prof Gillies said the treat-andextend regimen – where intervals between eye injections are extended as long as lesions remain inactive – appears to be the most efficient way to deliver an adequate number of injections, if injection intervals are not extended beyond three months.5

    Eyes with initially good vision were also more likely to complete 10 years of treatment, according to the study published in the prestigious American Journal of Ophthalmology.6

    “Our 10-year outcomes for nAMD were much better than those of the SEVENUP study,7 which claimed that practically all eyes would develop central macular atrophy within seven years. We showed that this is not true,” said Prof Gillies.

    While his analysis of the FRB! project has mainly focused on nAMD to date, he now plans to broaden his focus to other retinal conditions, as well as grow the number of international practitioners contributing to the registry.

    “MDFA funding has assisted the project to expand considerably in terms of international recruitment and data acquisition for the main macular diseases we can treat: nAMD, diabetic macular oedema and retinal vein occlusion,” said Prof Gillies.

    “Future directions for the project will focus on consolidating our international presence, particularly in Europe, and analyses of outcomes for diabetic macular oedema and retinal vein occlusion, for which there are currently very little real-world data.”

    MDFA Research Grants

    Professor Mark Gillies received a Macular Disease Foundation Australia Research Grant of $400,000 over three years in 2015 to expand the Fight Retinal Blindness! Registry.

    Since 2011, MDFA has invested $4.1 million across 21 projects, and committed a further $1.1 million to eight exciting projects in May 2021.

    This includes the new Grant Family Fund, an additional stream of funding for early-career researchers for ‘blue-sky’ research in the field of macular disease, offering a total grant pool of up to $100,000.

    MDFA funding is awarded following rigorous evaluation based on the National Health and Medical Research Council (NHMRC) guidelines. International peer review ensures successful applicants meet the highest standards.

    Learn more about the other projects MDFA’s Research Grants Program has supported.

    References

    1. Rosenfeld PJ, Brown DM, Heier JS, et al. Ranibizumab for neovascular age-related macular degeneration. N Engl J Med 2006;355:1419-31.
    2. Brown DM, Michels M, Kaiser PK, Heier JS, Sy JP, Ianchulev T. Ranibizumab versus verteporfin photodynamic therapy for neovascular age-related macular degeneration: Two-year results of the ANCHOR study. Ophthalmology 2009;116:57-65.e5.
    3. Gillies MC, Walton R, Liong J, et al. Efficient capture of high-quality data on outcomes of treatment for macular diseases: the fight retinal blindness! Project. Retina 2014;34:188-95.
    4. Gillies MC, Nguyen V, Daien V, Arnold JJ, Morlet N, Barthelmes D. Twelve-Month Outcomes of Ranibizumab vs. Aflibercept for Neovascular Age-Related Macular Degeneration: Data from an Observational Study. Ophthalmology. 2016;123:2545-2553
    5. Essex RW, Nguyen V, Walton R, et al. Treatment Patterns and Visual Outcomes during the Maintenance Phase of Treat-and-Extend Therapy for Age- Related Macular Degeneration. Ophthalmology. 2016;123(11):2393-2400.
    6. Gillies M, Arnold J, Bhandari S, Essex RW, Young S, Squirrell D, Nguyen V, Barthelmes D; Ten-Year Treatment Outcomes of Neovascular Age-Related Macular Degeneration from two regions. Am J Ophthalmol. 2019
    7. Rofagha S, Bhisitkul RB, Boyer DS, Sadda SR, Zhang K. Seven-Up Study Group. Seven-year outcomes in ranibizumab-treated patients in ANCHOR, MARINA, and HORIZON: a multicenter cohort study (SEVEN-UP). Ophthalmology. 2013;120(11):2292-2299.

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