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A retrospective study of the real-life utilization and effectiveness of ranibizumab therapy for neovascular age-related macular degeneration in the UK
Open accessAbstract
PURPOSE: AURA was an international, retrospective, observational study that monitored the real-life use and effectiveness of ranibizumab injections in patients with neovascular age-related macular degeneration (nAMD). This paper reports the findings from the UK. METHODS: Patients who started treatment with ranibizumab between January 1, 2009, and August 31, 2009, and had documented follow-up to the end of their treatment and/or monitoring or until August 31, 2011, were retrospectively monitored; the diagnosis and subsequent decision to treat was made by the patient's own physician. Assessments included the change in visual acuity (standardized letter count) during the first and second years after start of ranibizumab therapy and resource utilization. RESULTS: Four hundred and ten patients from 13 UK centers were analyzed. The mean (standard deviation [SD]) letter score at baseline was 55.0 (17.8). The mean (SD) change in visual acuity from baseline was +6.0 (15.4) letters at year 1 and +4.1 (16.9) at year 2. Most of the patients (86.6%) completed a 3-month loading phase; the visual improvements were numerically higher in these patients. Over 2 years, the mean (SD) number of clinic visits and injections was 18.4 (5.0) and 9.0 (4.7), respectively. Resource use and visual acuity gains were greater than those observed in the global population, which included other countries enrolled in AURA (Canada, France, Germany, Ireland, Italy, the Netherlands, and Venezuela). When patients were stratified according to severity of nAMD (based on letter count at baseline), the mean change in visual acuity score at years 1 and 2 was also higher for the UK than for the global population across all subgroups. CONCLUSION: Monitoring and treatment rates were high in the UK, resulting in better visual acuity outcomes compared with other included countries. This suggests that translation of clinical study outcomes into real-life settings is achievable, but at the expense of higher resource utilization than is currently the norm in most developed countries.
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Real world visual outcomes do not match those of clinical trials.
“Further, real world visual outcomes do not match those of clinical trials.8,10,11”
From Safety and efficacy of ixoberogene soroparvovec in neovascular age-related macular degeneration in the United States (OPTIC): a prospective, two-year, multicentre phase 1 study (2024) · cites this paper as [10]
The Discussion says visual outcomes were poorer than in clinical studies in countries with less frequent monitoring and treatment, and reports a similar mismatch in a larger real-world study. But it also says the UK cohort’s outcomes were only slightly lower than trial outcomes and that translating trial outcomes into practice is achievable. The unqualified claim overgeneralizes the paper’s findings; page numbers were not provided. (LLM, conf=0.85)
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Cites
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Busbee, B. G., Ho, A. C., Brown, D. M., Heier, J. S., Suñer, I. J., Li, Z., Rubio, R. G., & Lai, P. (2013) · Ophthalmology · doi:10.1016/j.ophtha.2012.10.014 · Cited by 500
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Research works printed but not linked: 14
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Khanani, A. M., Boyer, D. S., Wykoff, C. C., Regillo, C. D., Busbee, B. G., Pieramici, D., Danzig, C. J., Joondeph, B. C., Major, J. C., Turpcu, A., et al. (2024) · eClinicalMedicine · doi:10.1016/j.eclinm.2023.102394 · Cited by 76
“8,10,11 This is due in part to the considerable treatment burden of frequent injections and signi fi cant undertreatment in many real-world settings, with patients in some studies receiving fewer than”
Background
Metadata
- Authors
- Sivaprasad, S., Hykin, P., Chakravarthy, U., Lotery, A., McKibbin, M., & Napier, J.
- Affiliations
- National Institute for Health and Care Research (GB)
- Queen's University Belfast (GB)
- University of Southampton (GB)
- St James's University Hospital (GB)
- Bayer (United Kingdom) (GB)
- Corresponding author
- Sivaprasad, Sobha
- Venue
- Clinical Ophthalmology
- Publisher
- Informa UK Limited
- Published
- 2016-01
- Volume
- 10
- Pages
- 87
- ISSN
- 1177-5467 (ISSN-L)
- 1177-5483
- PMC
- PMC4716754
- OpenAlex
- W2234869633
- Cited by
- 31
- References
- 4
- Citations by year
- 2025: 1 · 2024: 2 · 2023: 2 · 2022: 2 · 2021: 4 · 2020: 5 · 2019: 4 · 2018: 3 · 2017: 7 · 2016: 1
- FWCI
- 5.31
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- Clinical ophthalmology (publishedVersion, cc-by-nc)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- ePrints Soton (University of Southampton) (acceptedVersion)
- Funders
- National Institute for Health and Care Research (NF-SI-0515-10020)
- Bayer HealthCare
- Allergan
- Topics
- Health Sciences › Medicine › Ophthalmology › Retinal Diseases and Treatments
- Health Sciences › Medicine › Ophthalmology › Retinal and Macular Surgery
- Health Sciences › Medicine › Ophthalmology › Ocular Diseases and Behçet’s Syndrome
- Keywords
- ranibizumab, neovascular age-related macular degeneration, real-world effectiveness, visual acuity outcomes, resource utilization (health care), anti-VEGF therapy, loading phase, medication adherence, UK patients
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