Abstract
Background/Objectives
The acceptability of emerging intravitreal therapies for patients with Geographic Atrophy (GA) is currently unknown. This study therefore aimed to investigate the extent to which regular intravitreal injections may be acceptable to GA patients.
Subjects/Methods
Thirty UK-based individuals with GA secondary to age-related macular degeneration (AMD), recruited from two London-based hospitals, were interviewed in April-October 2021 regarding acceptability of new GA treatments. Participants responded to a structured questionnaire, as well as open-ended questions in a semi-structured interview. The Theoretical Framework of Acceptability (TFA) informed framework analysis of the qualitative data.
Results
Twenty participants (67%) were female, and median (interquartile range (IQR)) age was 83 (78, 87) years. 37% of participants had foveal centre-involving GA, and better eye median (IQR) logMAR visual acuity was 0.30 (0.17, 0.58). Data suggested that 18 participants (60% (95% CI: 41–79%)) would accept the treatment, despite awareness of potential drawbacks. Eight participants (27% (95% CI: 10–43%) were ambivalent or undecided about treatment, and four (13%) (95% CI: 0–26%) would be unlikely to accept treatment. Reducing the frequency of injections from monthly to every other month increased the proportion of participants who considered the treatments acceptable. Conversely, factors limiting acceptability clustered around: the limited magnitude of treatment efficacy; concerns about side effects or the increased risk of neovascular AMD; and the logistical burden of regular clinic visits for intravitreal injections. Misunderstandings of potential benefits indicate the need for appropriately-designed patient education tools to support decision-making.
Conclusions
Our study suggests a majority of participants would be positive about intravitreal treatment for GA, in spite of potential burdens.
Similar content being viewed by others
Log in or create a free account to read this content
Gain free access to this article, as well as selected content from this journal and more on nature.com
or
Data availability
The raw datasets generated during and analysed during the current study are not publicly available, because the in-depth and specific information they contain could compromise the privacy of the participants, given that most participants were recruited from a single London-based site. However, elements of the anonymised raw data may be shareable on reasonable request; in which case, please contact the corresponding author for further information.
References
Owen CG, Jarrar Z, Wormald R, Cook DG, Fletcher AE, Rudnicka AR. The estimated prevalence and incidence of late stage age related macular degeneration in the UK. Br J Ophthalmol. 2012;96:752–6.
Dinah C, Enoch J, Ghulakhszian A, Taylor DJ, Crabb DP. Intravitreal treatment for geographic atrophy: coming soon to a patient near you? Eye. 2021;36:1121–3.
Varma R, Souied EH, Tufail A, Tschosik E, Ferrara D, Zhang J, et al. Maximum reading speed in patients with geographic atrophy secondary to age-related macular degeneration. Invest Ophthalmol Vis Sci. 2018;59:195–201.
Krezel AK, Hogg R, Lohfeld L, Chakravarthy U, Azuara-Blanco A. Core outcomes for geographic atrophy trials. Br J Ophthalmol. 2020;104:1196–202.
Lally DR, Heier JS, Sadda S, Eichenbaum DA & Danzig C Progression of Atrophy in AMD: Post Hoc Analysis From the GATHER1 Study. 2022. https://investors.ivericbio.com/static-files/4341199c-b031-45a0-bc6f-a032a44a8021 [cited 2022 Sep 1].
Heier J, Singh R, Wykoff C, Steinle N, Boyer D, Monés J, et al. Efficacy of intravitreal pegcetacoplan in geographic atrophy: 24-month results from the phase 3 OAKS and DERBY trials. In 2022 [cited 2022 Nov 28]. Available from: https://investors.apellis.com/static-files/78d1b209-7324-4c4c-8b20-bf7778493bae.
Loewenstein A, Trivizki O. Future perspectives for treating patients with geographic atrophy. Graefe’s Arch Clin Exp Ophthalmol. 2022. https://doi.org/10.1007/s00417-022-05931-z.
Hutton D. Industry leaders react to FDA’s pegcetacoplan approval. Ophthalmology Times [Internet]. 2023; Available from: https://www.ophthalmologytimes.com/view/industry-leaders-react-to-fda-s-pegcetacoplan-approval.
Ehlken C, Ziemssen F, Eter N, Lanzl I, Kaymak H, Lommatzsch A, et al. Systematic review: Non-adherence and non-persistence in intravitreal treatment. Graefe’s Arch Clin Exp Ophthalmol. 2020;258:2077–90.
Droege KM, Muether PS, Hermann MM, Caramoy A, Viebahn U, Kirchhof B, et al. Adherence to ranibizumab treatment for neovascular age-related macular degeneration in real life. Graefe’s Arch Clin Exp Ophthalmol. 2013;251:1281–4.
Finger RP, Daien V, Eldem BM, Talks JS, Korobelnik JF, Mitchell P, et al. Anti-vascular endothelial growth factor in neovascular age-related macular degeneration - a systematic review of the impact of anti-VEGF on patient outcomes and healthcare systems. BMC Ophthalmol. 2020;20:294.
Boyle J, Vukicevic M, Koklanis K, Itsiopoulos C, Rees G. Experiences of patients undergoing repeated intravitreal anti-vascular endothelial growth factor injections for neovascular age-related macular degeneration. Psychol Health Med. 2018;23:127–40.
Senra H, Ali Z, Balaskas K, Aslam T. Psychological impact of anti-VEGF treatments for wet macular degeneration: a review. Graefe’s Arch Clin Exp Ophthalmol. 2016;254:1873–80.
Thier A, Holmberg C. The patients’ view: age-related macular degeneration and its effects–a meta-synthesis. Disabil Rehabil. 2022;44:661–71.
Fleckenstein M, Mitchell P, Freund KB, Sadda S, Holz FG, Brittain C, et al. The progression of geographic atrophy secondary to age-related macular degeneration. Ophthalmology. 2018;125:369–90.
Colijn JM, Liefers B, Joachim N, Verzijden T, Meester-Smoor MA, Biarnés M, et al. Enlargement of geographic atrophy from first diagnosis to end of life. JAMA Ophthalmol. 2021;139:743–50.
Sekhon M, Cartwright M, Francis JJ. Acceptability of healthcare interventions: An overview of reviews and development of a theoretical framework. BMC Health Serv Res. 2017;17:88.
Klaic M, Kapp S, Hudson P, Chapman W, Denehy L, Story D, et al. Implementability of healthcare interventions: An overview of reviews and development of a conceptual framework. Implement Sci. 2022;17:1–20.
Klassen AC, Creswell J, Plano Clark VL, Smith KC, Meissner HI. Best practices in mixed methods for quality of life research. Qual Life Res. 2012;21:377–80.
Enoch J, Ghulakhszian A, Crabb DP, Dinah C, Taylor DJ. Acceptability of intravitreal injections in geographic atrophy: Protocol for a mixed-methods pilot study. BMJ Open. 2021;11:e049495.
Liao DS, Grossi FV, El Mehdi D, Gerber MR, Brown DM, Heier JS, et al. Complement C3 inhibitor pegcetacoplan for geographic atrophy secondary to age-related macular degeneration: A randomized phase 2 trial. Ophthalmology. 2020;127:186–95.
Jaffe GJ, Westby K, Csaky KG, Monés J, Pearlman JA, Patel SS, et al. C5 inhibitor Avacincaptad pegol for geographic atrophy due to age-related macular degeneration: a randomized pivotal phase 2/3 trial. Ophthalmology. 2021;128:576–86.
Freeman WR, Bandello F, Souied EH, Guymer RH, Garg S, Chen FK, et al. Phase 2b Study of Brimonidine DDS: Potential novel treatment for geographic atrophy. Invest Ophthalmol Vis Sci. 2019;60:971.
UK Government. Regional ethnic diversity [Internet]. 2020 [cited 2022 Sep 9]. Available from: https://www.ethnicity-facts-figures.service.gov.uk/uk-population-by-ethnicity/national-and-regional-populations/regional-ethnic-diversity/latest.
Sandelowski M. Sample size in qualitative research. Res Nurs Health. 1995;18:179–83.
Holz FG, Ho A, Khanani AM, Chang A, Bliss C, Sharp D, et al. Efficacy of Pegcetacoplan in subgroups defined by distance from the foveal center point in the phase 3 OAKS and DERBY studies of patients with geographic atrophy. In: The Macula Society 45th Annual Meeting, Berlin, Germany. 2022. Available from: https://investors.apellis.com/static-files/adcd2696-44f6-41f2-bbb8-4cb517cdd67c [cited 2022 Sep 13].
Richardson SJ, Carroll CB, Close J, Gordon AL, O’Brien J, Quinn TJ, et al. Research with older people in a world with COVID-19: identification of current and future priorities, challenges and opportunities. Age Ageing. 2020;49:901–6.
Ritchie J, Spencer L. Qualitative data analysis for applied policy research. In: Analysing qualitative data. (Routledge, London, 1994) 173–94.
Gale NK, Heath G, Cameron E, Rashid S, Redwood S. Using the framework method for the analysis of qualitative data in multi-disciplinary health research. BMC Med Res Methodol. 2013;13:117.
Guest G, MacQueen KM, Namey EE. Applied Thematic Analysis. (Sage, Thousand Oaks, 2012).
Künzel SH, Möller PT, Lindner M, Goerdt L, Nadal J, Schmid M, et al. Determinants of quality of life in geographic atrophy secondary to age-related macular degeneration. Invest Ophthalmol Vis Sci. 2020;61:63.
Keenan TD, Agrón E, Domalpally A, Clemons TE, van Asten F, Wong WT, et al. Progression of geographic atrophy in age-related macular degeneration: AREDS2 report number 16. Ophthalmology. 2018;125:1913–28.
Goldberg R, Heier J, Wykoff CC, Staurenghi G, Singh RP, Steinle N, et al. Efficacy of intravitreal pegcetacoplan in patients with geographic atrophy (GA): 12-month results from the phase 3 OAKS and DERBY studies. 2022. https://investors.apellis.com/static-files/ed761716-e969-4d23-a352-541fa01fd557 [cited 2022 Aug 31].
Sadda SR, Sarraf D. Therapeutic Margin for Geographic Atrophy: The Race Between Longevity and Disease Progression. JAMA Ophthalmol. 2021;139:751–2.
Singh RP, Boyer DS, Lad EG, Holz FG, Bliss C, Wong JG, et al. Efficacy of Intravitreal Pegcetacoplan in Geographic Atrophy: 24-Month Results from the Phase 3 OAKS and DERBY Trials. 2022. https://investors.apellis.com/static-files/a1ec9fdb-ef70-49c1-ae6e-5ad7caa63abe [cited 2022 Oct 24].
Iveric Bio. Iveric Bio Announces Positive Topline Data from Zimura® GATHER2 Phase 3 Clinical Trial in Geographic Atrophy [Internet]. Parsippany, New Jersey; 2022 Sep [cited 2022 Sep 9]. Available from: https://investors.ivericbio.com/news-releases/news-release-details/iveric-bio-announces-positive-topline-data-zimurar-gather2-phase.
Bouaziz M, Cheng T, Minuti A, Denisova K, Barmettler A. Shared decision making in ophthalmology: A scoping review. Am J Ophthalmol. 2021;237:146–53.
Scheffer M, Menting J, Roodbeen R, van Dulmen S, van Hecke M, Schlingemann R, et al. Patients’ and health professionals’ views on shared decision‐making in age‐related macular degeneration care: A qualitative study. Ophthalmic Physiol Opt. 2022;42:1015–22.
Taylor DJ, Jones L, Binns AM, Crabb DP. ‘You’ve got dry macular degeneration, end of story’: A qualitative study into the experience of living with non-neovascular age-related macular degeneration. Eye. 2020;34:461–73.
Carlton J, Barnes S, Haywood A. Patient Perspectives in Geographic Atrophy (GA): Exploratory qualitative research to understand the impact of GA for patients and their families. Br Ir Orthopt J. 2019;15:133.
Acknowledgements
We would like to thank each of the thirty participants who took part in this study and generously volunteered their time and insights. We would also like to thank the members of our GA Patient Advisory Group for their invaluable input into developing the study.
Funding
National Institute for Health Research (NIHR) Enabling Involvement Fund (EIF) (Grant number EIFApp ID: 397). City, University of London School of Health Sciences Higher Education Innovation Fund (HEIF). Apellis Pharmaceuticals (Grant ID: AMR-000001). The funding organizations had no role in the design or conduct of this research.
Author information
Authors and Affiliations
Contributions
All authors contributed to the study conception and design. Material preparation, data collection and analysis were performed by authors JE, AG, DJT and CD. Expert support regarding treatment acceptability and the Theoretical Framework of Acceptability was provided by MS. Supervision was provided by DPC and CD. The first draft of the manuscript was written by JE and all authors commented on several draft versions of the manuscript. All authors read and approved the final manuscript. All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published.
Corresponding author
Ethics declarations
Competing interests
Jamie Enoch, Arevik Ghulakhszian and Mandeep Sekhon declare that they have no competing interests. David P Crabb reports grants from Roche, grants and personal fees from Santen, grants and personal fees from Apellis, grants from Allergan, personal fees from Thea, personal fees from Bayer and personal fees from Centervue, outside the submitted work. DPC receives funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant 116076 (Macustar). This joint undertaking receives support from the European Union’s Horizon 2020 research and innovation program and European Federation of Pharmaceutical Industries and Associations (EFPIA). The communication reflects the author’s view and that neither IMI nor the European Union, EFPIA, or any Associated Partners are responsible for any use that may be made of the information contained therein. Deanna J Taylor holds a research grant from Apellis. Christiana Dinah has served on advisory boards for Novartis, AbbVie, Ora Clinical, Roche and Apellis. CD is on the scientific advisory board for Ora Clinical, has received speaker fees from Roche and Novartis and holds a research grant from Apellis.
Additional information
Publisher’s note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
Supplementary information
Rights and permissions
Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.
About this article
Cite this article
Enoch, J., Ghulakhszian, A., Sekhon, M. et al. Exploring patient acceptability of emerging intravitreal therapies for geographic atrophy: A mixed-methods study. Eye 37, 3634–3642 (2023). https://doi.org/10.1038/s41433-023-02571-3
Received:
Revised:
Accepted:
Published:
Version of record:
Issue date:
DOI: https://doi.org/10.1038/s41433-023-02571-3
This article is cited by
-
Implementing patient and public involvement (PPI) in eye research: reflections from developing a research study on Geographic Atrophy treatment acceptability
Research Involvement and Engagement (2025)
-
Clinical Trial Simulation in Geographic Atrophy: Patient, Caregiver, and Trial Site Staff Perspectives
Ophthalmology and Therapy (2025)
-
Piloting a forced-choice task to elicit treatment preferences in geographic atrophy
BMC Research Notes (2023)
