Cerebrovascular accidents in patients treated for choroidal neovascularization with ranibizumab in randomized controlled trials.
ABSTRACT : To analyze cerebrovascular accidents (CVAs) pooled from large, randomized, controlled clinical trials of ranibizumab treatment for neovascular age-related macular degeneration.
: Events in five trials (FOCUS, MARINA, ANCHOR, PIER, and SAILOR) were analyzed using a standard safety monitoring process. Exact methods, stratified by study, were used to test for treatment differences based on odds ratios. A stepwise logistic regression model was fit to classify subjects' risk for CVA based on medical history. Treatment differences in CVA rates at 1 year or 2 years were evaluated within risk groups using stratified exact methods.
: Pooled 2-year CVA rates were <3%; odds ratios (95% confidence intervals) for CVA risk were 1.2 (0.4-4.4) for ranibizumab 0.3-mg versus control, 2.2 (0.8-7.1) for 0.5 mg versus control, and 1.5 (0.8-3.0) for 0.5-mg versus 0.3-mg ranibizumab. No substantial increased risk of CVA for 0.5 mg versus 0.3 mg was identified in pooled analyses or any of the individual trials. In pooled analyses, the difference between 0.5-mg ranibizumab and control was larger (7.7 [1.2-177]) among high-risk CVA patients.
: This analysis provided some evidence, although not definitive, of a potential increased risk of CVA with ranibizumab versus control or with 0.5-mg versus 0.3-mg ranibizumab. Continued monitoring for CVA within clinical trials seems warrented.
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ABSTRACT: To evaluate the anatomic and functional effect of microincision vitrectomy surgery (MIVS) with internal limiting membrane (ILM) peeling for macular edema secondary to branch retinal vein occlusion (BRVO). The medical records of 101 eyes of 101 patients who had undergone MIVS with ILM peeling for macular edema secondary to BRVO were studied. Patients were classified into ischemic and non-ischemic BRVO based on angiograph. The best-corrected visual acuity (BCVA) and central foveal thickness (CFT), determined by spectral domain optical coherence tomography, were evaluated at baseline and at 1, 3, 6, and 12 months postoperatively. Preoperative mean logarithm of the minimum angle of resolution (logMAR) BCVA ± standard deviation (SD) was 0.52±0.43 and mean CFT ± SD was 489.4±224.9 μm. Postoperative mean BCVA ± SD values were 0.41±0.35, 0.35±0.41, 0.29±0.36, and 0.25±0.41, and mean CFT values were 370.1±148.9, 327.5±157.5, 310.9±154.9, and 274.4±135.3 μm at 1, 3, 6, 12 months, respectively. The mean BCVA was significantly improved at 3, 6, and 12 months postoperatively (all P<0.05), and the mean CFT was significantly decreased at all postoperative follow-up time points (all P<0.05). At the 12-month postoperative evaluation, BCVA had improved by 0.2 logMAR units in 50 eyes (60.0%) with ischemic BRVO and in nine eyes (50.0%) with non-ischemic BRVO. Six eyes (6.0%) experienced recurrence or persistence of macular edema at 12 months postoperatively. MIVS with ILM peeling for macular edema secondary to BRVO is effective in improving visual acuity and foveal morphology with low recurrence of macular edema.Clinical ophthalmology (Auckland, N.Z.) 03/2015; 9:439-44. DOI:10.2147/OPTH.S75659
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ABSTRACT: Abstract The treatment of neovascular age-related macular degeneration (AMD) and other pathologic ocular conditions that overexpress the vascular endothelial growth factor (VEGF) has been revolutionized in the last decade by the introduction of intravitreal agents that target the VEGF pathway. Since treatment trials are designed primarily to assess the prevention of vision loss caused by ocular conditions, they are inadequate for detecting rare, but potentially serious, systemic side effects. The aim of this article is to present what the ophthalmologist needs to know about systemic complications from anti-VEGF therapy and review the likelihood that these side effects occur in the context of small, but often-repeated, intravitreal doses of these potent biological medications. Preferred practice patterns need to be developed that weigh the ability of these medications to mitigate potentially blinding conditions, while at the same time minimizing the risk of adverse outcomes in specific patient populations that possess multiple and often interrelated medical comorbidities.Seminars in Ophthalmology 11/2014; 29(5-6):263-75. DOI:10.3109/08820538.2014.959195 · 1.20 Impact Factor
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ABSTRACT: Diabetic macular oedema (DMO) is a common complication of diabetic retinopathy. Although grid or focal laser photocoagulation has been shown to reduce the risk of visual loss in DMO, or clinically significant macular oedema (CSMO), vision is rarely improved. Antiangiogenic therapy with anti-vascular endothelial growth factor (anti-VEGF) modalities is used to try to improve vision in people with DMO.Cochrane database of systematic reviews (Online) 01/2014; 10(10):CD007419. DOI:10.1002/14651858.CD007419.pub4 · 5.70 Impact Factor