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M. D. Bennett, J. S. Bryan, P. H. Scharper, Jr., C. S. Otto; Ranibizumab (Lucentis®) for Cystoid Macular Edema Secondary to Non-Ischemic Retinopathy. Invest. Ophthalmol. Vis. Sci. 2008;49(13):2690.
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Cystoid macular edema (CME) is the most common cause of suboptimal postoperative visual acuity in uncomplicated cataract extractions. In the US, there are an estimated 20,000-130,000 annual cases of idiopathic occurrence of CME following cataract extractions. CME accompanied by angiographic evidence of leakage is related to a physiological inflammatory process, which if not resolved quickly may result in visual loss. Topical, periocular, or intravitreal corticosteroids, despite their associated adverse events, are the mainstay in pharmacologic treatment for CME. Recent case reports have shown benefit from anti-vascular endothelial growth factor (anti-VEGF) therapy in CME following cataract extractions. The purpose of this study is to assess the safety and efficacy of monthly intravitreal injections of the anti-VEGF agent ranibizumab in patients with CME secondary to non-ischemic retinopathy.
In this ongoing, open-label, 12-month, phase 2 study, ranibizumab is being evaluated in 30 patients with CME secondary to non-ischemic retinopathy, following cataract surgery with intraocular lens implantation. Inclusion of patients with CME secondary to non-ischemic retinopathy essentially excludes patients with concomitant diabetes. Patients receive 6 monthly intravitreal injections of ranibizumab with a follow-up evaluation at month 12. The primary endpoint is the incidence and severity of adverse events. Secondary endpoints include changes in the following measures from baseline to months 6 and 12: best-corrected ETDRS visual acuity, central retinal thickness and macular edema as assessed by optical coherence tomography, and extent of hemorrhage as assessed by fluorescein angiography.
To date, 28 of 30 patients are enrolled in this study, and no adverse events have been reported. Preliminary findings show that macular edema in some patients resolved or remained the same after initiation of ranibizumab treatment. Twelve-month data will be presented.
Preliminary data from this study suggest that ranibizumab is safe and may be beneficial in the treatment of CME secondary to non-ischemic retinopathy.
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