| Literature DB >> 33895721 |
Jamie Enoch1, Arevik Ghulakhszian2, David P Crabb1, Christiana Dinah2, Deanna J Taylor3.
Abstract
INTRODUCTION: Age-related macular degeneration (AMD) is a common cause of visual impairment, affecting central vision. Geographic atrophy (GA) is an advanced form of the non-neovascular (dry) type of AMD. Late-stage clinical trials suggest that intravitreal injections of novel therapeutics may slow down the rate of GA progression by up to 30% in 1 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. Therefore, this mixed-methods pilot study will aim to explore whether regular intravitreal injections will be acceptable as treatment for patients with GA, and the factors that may affect treatment acceptability. METHODS AND ANALYSIS: A mixed-methods survey has been designed in collaboration with a GA patient advisory group. The survey comprises of structured questionnaires, semi-structured interview questions regarding patients' perceptions of intravitreal injections and the burden of treatment, and a task eliciting preferences between different potential treatments. Due to COVID-19 restrictions, this study will be conducted remotely by telephone. Thirty individuals will be recruited from NHS Medical Retina clinics at Central Middlesex Hospital, London. Half of the participants will be naïve to intravitreal injections, while half will have previous experience of intravitreal injections for neovascular (wet) AMD. Qualitative data analysis will be conducted using the Framework Method of analysis to identify key themes from participants' accounts. ETHICS AND DISSEMINATION: The study received Health Research Authority approval on 23 March 2021 (IRAS Project ID: 287824). 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. © Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.Entities:
Keywords: health services administration & management; medical retina; qualitative research
Mesh:
Substances:
Year: 2021 PMID: 33895721 PMCID: PMC8074551 DOI: 10.1136/bmjopen-2021-049495
Source DB: PubMed Journal: BMJ Open ISSN: 2044-6055 Impact factor: 2.692
Summary of investigational intravitreal treatments for GA
| Name of drug | Trial name (ClinicalTrials.gov identifier) | Interim or published results |
| APL-2 | FILLY (NCT02503332) | In a phase II trial, APL-2 administered monthly via intravitreal injection showed a 29% statistically significant reduction in the rate of GA lesion growth compared with sham after 12 months of treatment. |
| Zimura (avacincaptad pegol) | GATHER1 phase II/III trial (NCT02686658) | In a phase II/III trial, avacincaptad pegol administered monthly via intravitreal injection significantly reduced GA growth over 12 months by 27.4% (2 mg cohort) and 27.8% (4 mg cohort) compared with sham. |
| Brimonidine (Brimo DSS) | BEACON (NCT02087085) | In a phase IIb study, Brimo DDS administered every 3 months via intravitreal injection significantly decreased GA growth by 10% at month 24 and by 12% at month 30 compared with sham. |
| Lampalizumab | CHROMA (NCT02247479) | No statistically significant improvements. In phase III trials, patients with bilateral GA experienced a consistent decline in visual function over 48 weeks. Measures of visual function were not correlated strongly with GA lesion area. |
GA, geographic atrophy.
Figure 1Summary of factors that may affect acceptability of intravitreal treatments, based on the neovascular age-related macular degeneration literature.16 58 59
The seven component constructs in Sekhon et al’s theoretical framework of acceptability (TFA),25 and how these could apply to intravitreal treatment for GA
| Component construct in TFA | Definition within the TFA | Example with potential relevance to GA treatment |
| Affective attitude | How an individual feels about the intervention | Anxiety about the injection, despair and fear of losing vision, or hope of slowing vision loss. |
| Burden | The perceived amount of effort that is required to participate in the intervention | The challenges of monthly visits to clinic for injections, eg, associated pain and discomfort, transport issues, or potential impact on accompanying relatives. |
| Ethicality | The extent to which the intervention has a good fit with an individual’s value system | Some individuals with GA may be more proactive and feel they can take control by having injections. Meanwhile, other individuals could be more fatalistic (or accepting) about the inevitability of vision loss, especially if treatment outcomes are unclear or uncertain. |
| Intervention coherence | The extent to which the participant understands the intervention and how it works; the face validity of the intervention for the recipient | Clear understanding of the impact the intravitreal injections would have, in terms of slowing down the rate of vision loss from GA (rather than halting or reversing it). |
| Opportunity costs | The extent to which benefits, profits or values must be given up to engage in the intervention | If a person with GA (and/or an accompanying relative/caregiver) has to take time off work or cancel commitments to attend injections. |
| Perceived effectiveness | The extent to which the intervention is perceived as likely to achieve its purpose | An appreciable sense that the intravitreal injections are slowing the patient’s rate of vision loss. |
| Self-efficacy | The participant’s confidence that they can perform the behaviour required to participate in the intervention | Confidence in ability to attend regular injections and to persist with treatment over the long term. |
GA, geographic atrophy; NHS, National Health Service.
Figure 2Summary of overall study procedure. GA, geographic atrophy.
Figure 3Example of two of the options to be compared and discussed in the discrete choice experiment-style task. AMD, age-related macular degeneration.