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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 0.5mg 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 mm 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.
Author(s): Tufail A, Patel P, Sivaprasad S, Amoaku W, Browning AC, Cole M, Gale R, George S, Lotery AJ, Majid M, McKibbin M, Menon G, Yang Y, Andrews C, Brittain C, Osborne A
Publication type: Article
Publication status: Published
Print publication date: 01/06/2013
Online publication date: 01/06/2013
Acceptance date: 26/11/2012
ISSN (print): 0950-222X
ISSN (electronic): 1476-5454
Publisher: Nature Publishing Group
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