Abstract
Aims
To evaluate the efficacy and safety of intravitreal ranibizumab in patients with choroidal neovascularisation secondary to pathological myopia (myopic CNV). Data are from a pre-planned, 6-month interim analysis.
Methods
Phase II, open-label, single arm, multicentre, 12-month study, recruiting patients (aged ≥18 years) with active primary or recurrent subfoveal or juxtafoveal myopic CNV, with a best-corrected visual acuity (BCVA) score of 24–78 Early Treatment Diabetic Retinopathy Study (ETDRS) letters in the study eye and a diagnosis of high myopia of at least −6 dioptres.
Patients received 0.5 mg ranibizumab administered intravitreally to the study eye, followed by monthly injections given as needed (based on a predefined algorithm) for up to 11 months.
Results
At 6 months, mean BCVA improved from baseline by 12.2 letters, as did central macular thickness (in this interim analysis defined as a measure of either central subfield macular thickness or centre point macular thickness) from baseline by 108 μm in the 48 study eyes of 48 patients. Fewer patients had centre-involving intraretinal oedema (13.0% vs 91.5%), intraretinal cysts (10.9% vs 57.4%), or subretinal fluid (13.0% vs 66.0%) at 6 months than at baseline. Patients received a mean of 1.9 retreatments, were satisfied with ranibizumab treatment, and well being was maintained. No new safety signals were identified.
Conclusions
Results from the planned interim analysis support the role of ranibizumab in the treatment of myopic CNV, with excellent efficacy achieved with a low number of injections and few serious adverse events.
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Change history
13 June 2013
This article has been corrected since Advance Online Publication and a corrigendum is also printed in this issue.
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Acknowledgements
We thank Sue Harris and Sue Cheer representatives of ApotheCom for writing assistance (provision of first manuscript draft), which was funded by Novartis Pharmaceuticals Ltd. (UK). Novartis Pharmaceuticals UK Ltd., Surrey, UK participated in the design of the study, conducting the study, data collection, data management, data analysis, interpretation of the data, preparation and review of the manuscript. A Tufail, and PJ Patel have received a proportion of their funding from the Department of Health’s NIHR Biomedical Research Centre for Ophthalmology at Moorfields Eye Hospital and UCL Institute of Ophthalmology. The views expressed in the publication are those of the authors (AT and PP), and not necessarily those of the Department of Health.
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The institutes of the following authors have received funding from Novartis to cover the study-related costs: S Sivaprasad, W Amoaku, S George, A Lotery, A Browning, M McKibbin, and M Majid. W Amoaku has received support for travel to meetings in relation to this study. C Andrews, C Brittain, and A Osborne are employees of Novartis. A Tufail, PJ Patel, M Cole, R Gale, G Menon, and Y Yang have no conflict of interest to disclose.
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Previous presentation:1. American Academy of Ophthalmology Annual Meeting 2011.2. The Association for Research in Vision and Ophthalmology Annual Meeting 2012.3. The Royal College of Ophthalmology Annual Meeting 2012.
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Tufail, A., Patel, P., Sivaprasad, S. et al. Ranibizumab for the treatment of choroidal neovascularisation secondary to pathological myopia: interim analysis of the REPAIR study. Eye 27, 709–715 (2013). https://doi.org/10.1038/eye.2013.8
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DOI: https://doi.org/10.1038/eye.2013.8
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