Patient acceptability of intravitreal complement inhibitors in geographic atrophy (GA): protocol for a UK-based cross-sectional study
Introduction Geographic atrophy (GA) is the advanced form of the non-neovascular (‘dry’) type of age-related macular degeneration (AMD). Previously untreatable, complement inhibitors delivered by regular intravitreal injections have recently been demonstrated to slow down the progression of GA lesio...
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BMJ Publishing Group
2024-01-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/14/1/e075713.full |
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| author | David P Crabb Deanna J Taylor Christiana Dinah Mandeep Sekhon Jamie Enoch Arevik Ghulakhszian |
| author_facet | David P Crabb Deanna J Taylor Christiana Dinah Mandeep Sekhon Jamie Enoch Arevik Ghulakhszian |
| author_sort | David P Crabb |
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| description | Introduction Geographic atrophy (GA) is the advanced form of the non-neovascular (‘dry’) type of age-related macular degeneration (AMD). Previously untreatable, complement inhibitors delivered by regular intravitreal injections have recently been demonstrated to slow down the progression of GA lesions in phase 3 trials. One such treatment, Syfovre (pegcetacoplan), was approved by the US Food and Drug Administration in February 2023. These therapies slow down, but do not stop or reverse, the progression of GA; they may also increase the risk of developing the neovascular (‘wet’) type of AMD. In light of these developments, this study aims to quantify the acceptability of these new intravitreal injection treatments to patients with GA in the UK and explore factors that may influence the acceptability of these treatments.Methods and analysis In this cross-sectional, non-interventional study, the primary objective is to determine the proportion of patients with GA that find regular intravitreal therapy acceptable for slowing the progression of GA. We will use a validated acceptability questionnaire in order to quantify the acceptability of new treatments among patients with GA. The correlation between acceptability and functional and structural biomarkers of GA will be established. We will also explore demographic, general health and ocular factors that may influence acceptability. 180 individuals with a diagnosis of GA will be recruited from 7 to 8 participating National Health Service trusts across the UK. Multiple regression analysis will be conducted to determine the simultaneous effects of multiple factors on patient acceptability.Ethics and dissemination The study received ethical approval from the Health Research Authority on 14 March 2023 (IRAS Project ID: 324854). Findings will be disseminated through peer-reviewed publications and conference presentations to the medical retina community, as well as through dialogue with patients and macular disease charities. |
| format | Article |
| id | doaj-art-46ebb21bf89a4e389dc49b296a537753 |
| institution | OA Journals |
| issn | 2044-6055 |
| language | English |
| publishDate | 2024-01-01 |
| publisher | BMJ Publishing Group |
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| series | BMJ Open |
| spelling | doaj-art-46ebb21bf89a4e389dc49b296a5377532025-08-20T02:13:27ZengBMJ Publishing GroupBMJ Open2044-60552024-01-0114110.1136/bmjopen-2023-075713Patient acceptability of intravitreal complement inhibitors in geographic atrophy (GA): protocol for a UK-based cross-sectional studyDavid P Crabb0Deanna J Taylor1Christiana Dinah2Mandeep Sekhon3Jamie Enoch4Arevik Ghulakhszian5Department of Optometry & Visual Science, City University of London, London, UKDepartment of Optometry and Visual Science, City University, London, UKOphthalmology, London North West Healthcare NHS Trust, Harrow, UKPopulation Health Research Institute, St George’s University of London, London, UKCity University of London, London, UKOphthalmology Department, Central Middlesex Hospital, London, UKIntroduction Geographic atrophy (GA) is the advanced form of the non-neovascular (‘dry’) type of age-related macular degeneration (AMD). Previously untreatable, complement inhibitors delivered by regular intravitreal injections have recently been demonstrated to slow down the progression of GA lesions in phase 3 trials. One such treatment, Syfovre (pegcetacoplan), was approved by the US Food and Drug Administration in February 2023. These therapies slow down, but do not stop or reverse, the progression of GA; they may also increase the risk of developing the neovascular (‘wet’) type of AMD. In light of these developments, this study aims to quantify the acceptability of these new intravitreal injection treatments to patients with GA in the UK and explore factors that may influence the acceptability of these treatments.Methods and analysis In this cross-sectional, non-interventional study, the primary objective is to determine the proportion of patients with GA that find regular intravitreal therapy acceptable for slowing the progression of GA. We will use a validated acceptability questionnaire in order to quantify the acceptability of new treatments among patients with GA. The correlation between acceptability and functional and structural biomarkers of GA will be established. We will also explore demographic, general health and ocular factors that may influence acceptability. 180 individuals with a diagnosis of GA will be recruited from 7 to 8 participating National Health Service trusts across the UK. Multiple regression analysis will be conducted to determine the simultaneous effects of multiple factors on patient acceptability.Ethics and dissemination The study received ethical approval from the Health Research Authority on 14 March 2023 (IRAS Project ID: 324854). Findings will be disseminated through peer-reviewed publications and conference presentations to the medical retina community, as well as through dialogue with patients and macular disease charities.https://bmjopen.bmj.com/content/14/1/e075713.full |
| spellingShingle | David P Crabb Deanna J Taylor Christiana Dinah Mandeep Sekhon Jamie Enoch Arevik Ghulakhszian Patient acceptability of intravitreal complement inhibitors in geographic atrophy (GA): protocol for a UK-based cross-sectional study BMJ Open |
| title | Patient acceptability of intravitreal complement inhibitors in geographic atrophy (GA): protocol for a UK-based cross-sectional study |
| title_full | Patient acceptability of intravitreal complement inhibitors in geographic atrophy (GA): protocol for a UK-based cross-sectional study |
| title_fullStr | Patient acceptability of intravitreal complement inhibitors in geographic atrophy (GA): protocol for a UK-based cross-sectional study |
| title_full_unstemmed | Patient acceptability of intravitreal complement inhibitors in geographic atrophy (GA): protocol for a UK-based cross-sectional study |
| title_short | Patient acceptability of intravitreal complement inhibitors in geographic atrophy (GA): protocol for a UK-based cross-sectional study |
| title_sort | patient acceptability of intravitreal complement inhibitors in geographic atrophy ga protocol for a uk based cross sectional study |
| url | https://bmjopen.bmj.com/content/14/1/e075713.full |
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