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Patient acceptability of intravitreal complement inhibitors in geographic atrophy (GA): protocol for a UK-based cross-sectional study

Dinah, C. ORCID: 0000-0002-0815-4771, Enoch, J. ORCID: 0000-0002-4614-6676, Ghulakhszian, A. , Sekhon, M., Crabb, D. P. ORCID: 0000-0001-8611-1155 & Taylor, D. J. (2024). Patient acceptability of intravitreal complement inhibitors in geographic atrophy (GA): protocol for a UK-based cross-sectional study. BMJ Open, 14(1), article number e075713. doi: 10.1136/bmjopen-2023-075713


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.

Publication Type: Article
Additional Information: © Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See:
Publisher Keywords: Humans, Macular Degeneration, Angiogenesis Inhibitors, Cross-Sectional Studies, State Medicine, Complement Inactivating Agents, Geographic Atrophy, Wet Macular Degeneration, Intravitreal Injections, United Kingdom, Medical retina, Patient Reported Outcome Measures, Patient-Centered Care, Surveys and Questionnaires, Humans, Geographic Atrophy, Cross-Sectional Studies, Complement Inactivating Agents, State Medicine, Macular Degeneration, United Kingdom, Intravitreal Injections, Angiogenesis Inhibitors, Wet Macular Degeneration, 1103 Clinical Sciences, 1117 Public Health and Health Services, 1199 Other Medical and Health Sciences
Subjects: B Philosophy. Psychology. Religion > BF Psychology
R Medicine > RC Internal medicine > RC0321 Neuroscience. Biological psychiatry. Neuropsychiatry
R Medicine > RE Ophthalmology
R Medicine > RT Nursing
Departments: School of Health & Psychological Sciences
School of Health & Psychological Sciences > Optometry & Visual Sciences
School of Health & Psychological Sciences > Psychology
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