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• W2163233959 abstract "In recent years, anti-vascular endothelial growth factor (anti-VEGF) therapy has been shown to be effective for exudative age-related macular degeneration (AMD). However, the theoretically increased risk of cerebrovascular accidents or stroke that accompanies this therapy is a widely discussed concern.1Ueta T. Yanagi Y. Tamaki Y. Yamaguchi T. Cerebrovascular accidents in ranibizumab.Ophthalmology. 2009; 116: 362Abstract Full Text Full Text PDF PubMed Scopus (109) Google Scholar, 2Boyer D.S. Heier J.S. Brown D.M. et al.A phase IIIb study to evaluate the safety of ranibizumab in subjects with neovascular age-related macular degeneration.Ophthalmology. 2009; 116: 1731-1739Abstract Full Text Full Text PDF PubMed Scopus (271) Google Scholar, 3GenentechSafety Update on Lucentis.http://www.fda.gov/medwatch/safety/2007/Lucentis_DHCP_01-24-2007.pdfDate: 2007Google Scholar, 4Ueta T. Yanagi Y. Tamaki Y. Yamaguchi T. Ranibizumab and stroke.Ophthalmology. 2010; 117 (author reply 1860-1): 1860Abstract Full Text Full Text PDF PubMed Scopus (2) Google Scholar This report describes an industry-independent, cohort study that evaluated brain magnetic resonance imaging (MRI) scans of patients with exudative AMD who were treated additionally with pan-VEGF isoform antagonists. In order to evaluate the safety of this therapy, the current study was conducted, which consisted of 63 patients with exudative AMD who did not have a history of symptomatic stroke or myocardial infarction. The study group included patients with AMD lesions, who were then treated with anti-VEGF therapy at the time of enrollment, as well patients whose AMD lesions were quiescent or end-stage following treatments other than anti-VEGF therapy (i.e., photodynamic therapy [PDT], triamcinolone, or submacular surgery). Patients who had previously received anti-VEGF therapy were not included in the current study. Brain MRI was conducted on each patient twice at baseline and 6 months later. During the interval between MRI scans, the enrolled patients were treated with periodic 1.25 mg bevacizumab or 0.5 mg ranibizumab, which are pan-VEGF isoform antagonists. If necessary, patients who were treated additionally with PDT or pegaptanib were not excluded, though the actual number of patients treated was small (5 patients) and these treatments were assumed not to have significant effects on the brain. Sixty-three patients underwent brain MRI evaluations twice. Neuroradiologists (H.M. and A.K.), who were unaware of each patient's treatment regimen, evaluated the cerebrovascular integrity. During the 6-month interval, 26 patients did not receive either bevacizumab or ranibizumab, pan-VEGF isoform antagonists. Five patients each received 1 or 2 injections of pan-VEGF isoform antagonists. The remaining 27 patients were treated more intensively with 3 (19 patients) or 4 (8 patients) injections of pan-VEGF isoform antagonists. Of these 27 patients, 24 received 3 monthly loading injections of ranibizumab. Bevacizumab was only used for 3 of the 27 patients who received more intensive treatment, and all the 3 patients were also treated with ranibizumab during the 6 months; of these patients, 2 and 3 received pegaptanib and PDT, respectively. The effects of anti-VEGF therapy were evaluated based on the reinjection frequency. Since the most common regimen includes 3 monthly loading injections of ranibizumab, patients who received 0–2 injections of pan-VEGF antagonists were compared with those who received 3–4 injections. No apparent differences in terms of demographic features or past medical histories were noted at baseline (Table 1; available at http://aaojournal.org). The prevalence of silent stroke, as depicted on MRI at baseline, was also similar between these 2 groups: 33.3% (12/36) of the less intensively treated (0–2 injections per 6 months) patients and 29.6% (8/27) of the more intensively treated (3–4 injections per 6 months) patients (P = 0.79). This indicates that these 2 groups had similar susceptibilities to the cerebrovascular events at baseline. On the second MRI, new asymptomatic stroke lesions were found in 2 patients (7.4%) of the more intensively treated patients while no change was noted in any of the less intensively treated patients (Table 2 and Figure 1; available at http://aaojournal.org). The new silent stroke lesions were a cerebellar microbleed in 1 patient and cerebellar infarction in the other. Neither of the patients with new silent stroke had atrial fibrillation or was on anti-coagulant or anti-platelet medications. The difference between the groups was not statistically significant (P = 0.18). Generally, the side effects of a treatment depend on multiple factors, not only the dosage, frequency, and length of the treatment but also the patient's susceptibility to side effects. Consistent with this notion, in a currently ongoing worldwide clinical trial on ranibizumab for myopic choroidal neovascularization, a prior stroke history is a distinct criterion for exclusion from the study. Our results show that anti-VEGF therapy using pan-VEGF isoform antagonists up to 4 injections per 6 months does not confer significant adverse effects on the brain of AMD patients without a history of symptomatic stroke or myocardial infarction. However, our results also indicate further evaluation is necessary. A limitation of the current study is the relatively small sample size. The fact that small lesions in between the 5-mm slices of MRI images could have been overlooked is another limitation. However, the standardized procedures for all the patients and masked radiologists employed to evaluate the findings are strengths of this study. This current study was conducted after approval by the Institutional Review Board of The University of Tokyo Hospital, and its protocol adhered to the provisions of the Declaration of Helsinki. Written informed consent was obtained from all patients.Table 1Baseline Characteristics of the PatientsLess Intensively Treated (0–2 Injections of pan-VEGF Antagonists) n=36More Intensively Treated (3–4 injections of pan-VEGF Antagonists) n=27P ValueAge, years old (SD)76.5 (6.5)74.3 (7.0)0.22Male, n (%)23 (63.9)18 (66.7)1.0AMD subtype, n (%)0.46 Typical22 (61.1)17 (63.0) PCV12 (33.3)10 (37.0) RAP2 (5.6)0 (0.0)Smoking, n (%)0.63 Never12 (33.3)9 (33.3) Past14 (38.8)13 (48.1) Current10 (27.8)5 (18.5)Diabetes mellitus, n (%)4 (11.1)5 (18.5)0.48Hypertension, n (%)21 (58.3)14 (51.9)0.62Dyslipidemia, n (%)10 (27.7)9 (33.3)0.78Ischemic heart disease, n (%)0 (0.0)0 (0.0)NASymptomatic stroke, n (%)0 (0.0)0 (0.0)NAAMD = neovascular age-related macular degeneration; PCV = polypoidal choroidal vasculopathy; RAP = retinal angiomatous proliferation; SD = standard deviation; VEGF = vascular endothelial growth factor. Open table in a new tab Table 2Cerebrovascular Findings on MRI at Baseline and 6 Months LaterLess Intensivey Treated (n=36)More Intensively Treated (n=27)P ValueAsymptomatic stroke at baseline, n (%)12 (33.3)8 (29.6)0.79 Infarction without a hemorrhage, n97 Hemorrhage without a infarction, n20 Both infarction and hemorrhage, n11New asymptomatic stroke found after 6 months, n (%)0 (0.0)2 (7.4)0.18 Ischemic, n01 Hemorrhagic, n01 Open table in a new tab AMD = neovascular age-related macular degeneration; PCV = polypoidal choroidal vasculopathy; RAP = retinal angiomatous proliferation; SD = standard deviation; VEGF = vascular endothelial growth factor. MRI was conducted twice with 6 month interval. The interval period was within 6 months ± 2 weeks for all the enrolled patients. MRI was performed with a 1.5-T scanner with an 8-channel head coil (Signa 1.5T System; GE Medical Systems, Milwaukee, WI). The MRI sequences acquired were as follows: axial T1-weighted images, axial T2-weighted images, axial T2* images, axial and coronal fluid-attenuated inversion recovery (FLAIR) images, and axial diffusion-weighted images. T2* images were obtained in order to detect tiny hemorrhagic strokes. The slice thickness of each image was 5 mm for all sequences. Fisher exact test and Pearson's chi-square test were used for the categorical analyses and Mantel-Haenszel chi-square test for ordinal data analysis. Student t-test was used for the numerical data analyses. A P value of <0.05 was considered statistically significant. All the statistical analyses were performed using JMP7.0 software (SAS Inc., Cary, NC). Cerebrovascular Accidents in RanibizumabOphthalmologyVol. 116Issue 2PreviewIntravitreal injections of ranibizumab, an anti–vascular endothelial growth factor (VEGF) antibody for the treatment of patients with exudative age-related macular degeneration (AMD) has a remarkably favorable visual outcome compared with previous treatments. Despite its dramatic therapeutic effect, there is concern about possible systemic thromboembolic complications because its anti-angiogenic effect is potentially deleterious to normal cerebrocardiac functions. However, to date no study has had a sample size large enough to determine whether intravitreal ranibizumab injections increase the risk of adverse systemic effects. Full-Text PDF" @default.
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