Abstract
ObjectivesThe aim of this study was to obtain real-world clinical data on the safety and efficacy of ranibizumab treatment for myopic choroidal neovascularization (CNV) due to pathologic myopia.MethodsThis was a prospective, observational, post-marketing surveillance study in ranibizumab-naive Japanese patients with myopic CNV. Patients who initiated ranibizumab treatment were registered and prospectively observed over 12 months. Safety endpoints were the incidence of ocular and non-ocular adverse drug reactions (ADRs) and serious adverse events (SAEs). The efficacy endpoint included the average change in best-corrected visual acuity (BCVA) in logarithm of the minimal angle of resolution (logMAR) units (logMAR BCVA) from baseline to the last observation.ResultsThree hundred and eighteen patients were included in the safety analysis population. Of these 79.9% were female and the mean age was 65.5 years. The incidences of SAEs and ADRs were 0.6 and 0.3%, respectively. A total of 268 patients (84.0%) completed the 12-month study period. The mean (±SD) and median number of ranibizumab injections were 2.0 ± 1.5 and 1.0 during the 12-month study period, respectively. The number of ranibizumab injections received was one in 52.2% of patients and less than or equal to three in 89.2%. The mean change in logMAR BCVA from baseline to month 12 was −0.193, and the mean logMAR BCVA improved from 0.517 to 0.319 between baseline and month 12.ConclusionsThis study showed that ranibizumab is generally well tolerated, and that a minimum number of injections were necessary to produce a therapeutic effect in Japanese myopic CNV patients in a real-world setting.
Highlights
IntroductionAxial elongation causes the optical components of the eye to focus the image in front of the retina, and this is known as myopia
Pathologic myopia is a degenerative eye condition characterized by an abnormally elongated axial length that is Electronic supplementary material The online version of this article contains supplementary material, which is available to authorized users.≥3 standard deviations longer than the axial length of an emmetropic eye [1, 2]
High myopia is characterized by values exceeding −6.0 D and pathologic myopia is characterized by values greater than −8.0 D [3]
Summary
Axial elongation causes the optical components of the eye to focus the image in front of the retina, and this is known as myopia. Pathologic myopia can cause a range of pathologically morphological changes in the posterior fundus, notably choroidal neovascularization (CNV). Pathologic myopia is relatively common in Asian populations compared with non-Asian populations [4]. In the Hisayama study, the prevalence of pathologic myopia (myopic retinopathy) in Japanese patients aged over 40 was 1.2% in men and 2.2% in women [5]
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