Author: Christiana Dinah (United Kingdom)
Co-authors: Jamie Enoch, Arevik Ghulakhszian, Mandeep Sekhon, David P. Crabb, Deanna J. Taylor
Geographic atrophy (GA) is an advanced form of the non-neovascular (dry) type of age-related macular degeneration (AMD). Late-stage clinical trials suggest that intravitreal injections of novel therapeutics may slow down the rate of GA progression by up to 29% in one year, thus allowing people with GA to preserve central vision for a longer period. While intravitreal injections have become an established treatment modality for neovascular (wet) AMD, it is unknown whether patients with (more gradually progressing) GA would accept regular injections that slow down, but do not stop or reverse, vision loss. Patients are more likely to adhere to treatment recommendations and to benefit from improved clinical outcomes if they consider an intervention acceptable. Therefore, our group has begun to explore whether regular intravitreal injections will be acceptable as treatment for people living with GA, and the factors that may affect treatment acceptability. This work presents learnings from the initial patient involvement phase of the ‘AGAIN’ study, working with a patient advisory group of eight individuals living with GA who are helping to shape the overall AGAIN study’s design, analysis and dissemination.
We conducted two rounds of discussion activities with eight UK-based patient advisors. All discussions have been conducted remotely (by phone) due to Covid-19 restrictions.
In an initial discussion, we asked each of the eight advisory group members about their knowledge and understanding of GA, and their hopes for what treatment for GA might achieve. On the basis of this initial discussion, we compiled an information pack about GA which was posted out to our patient advisors. This contained general information about emerging intravitreal treatments being investigated in phase 3 clinical trials, their potential benefits and risks, and a brief proposed outline of our study on acceptability of intravitreal injections. We conducted follow-up calls with the patient advisors to discuss their interim thoughts on the information received by post. We tested out a range of structured and semi-structured questions to explore the acceptability of intravitreal injections for people living with GA. Lastly, we explored various methods of communicating reduction in rate of progression of GA lesions. Key points from the discussions were collated using the principles of the framework method of qualitative analysis, and we generated analytic summaries that encapsulated these discussions.
All of the advisors had GA in at least one eye, with total GA area between 1.5mm3–19mm3. Advisors were relatively knowledgeable about dry AMD being gradually progressive compared to wet AMD, although knowledge about GA specifically, including the terminology of ‘geographic atrophy’, was relatively low. In general, improvement of vision or reversal of visual loss was seen as ‘a bonus’, but all hoped that treatment would stop progression and prevent deterioration from current status. There was anxiety about the injection process, particularly among those who were injection-naïve. Advisors were concerned about any potential side-effects of treatment, the long-term effects of potentially lifelong treatment, potential consequences of missing appointments, and how described benefits would translate to their lived experience. They reasoned that personal circumstances (e.g. age; comorbidities; living/family situation; distance from and mode of transport to hospital), as well as individual differences in risk tolerance and in the value attributed to maintaining vision, would influence acceptability. We discussed how they interpreted ‘up to 29%’ slowing down of GA progression; most found this figure understandable but abstract. There was uncertainty regarding whether this rate of slowing would remain constant, and what the 29% slowing meant for likely continuation with vision-related daily activities.
Working with an advisory group of people living with GA has alerted us to the complexities that surround ‘acceptability’, and consequently the likely challenges for real-world adherence to and persistence with potential new intravitreal treatments for GA. Although such treatments are yet to be approved, we believe it is vital to consider prospective acceptability, in order to anticipate issues that could be addressed in advance; for instance, in terms of setting clear expectations, and providing adequate patient education and service delivery planning. This initial phase of patient advisory group discussions has informed the development of an ongoing mixed-methods pilot study, to explore the acceptability of intravitreal injections for GA. We will use a combination of quantitative, Likert-type scale questions, a semi-structured interview, and a patient preference task modelled on discrete choice experiments, to explore the attributes (e.g. injection frequency, time spent in hospital, probability of side-effects, potential benefit) that may influence prospective acceptability of intravitreal injections among people living with GA. Our research is being guided by the Theoretical Framework of Acceptability (Sekhon et al., 2017), and will be used to develop validated, standardised tools to assess acceptability in GA and retinal diseases more broadly.
CD (Presenting author) has served on advisory boards for Novartis, Allergan and Apellis. Co-authors JE, AG, MS and DJT have no interests to declare. Co-author DPC 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.