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R. A. Goodart, D. W. Faber, D. S. Mehr, H. Murphy, J. Gleed; Lucentis in the Treatment of Macular Edema (LIME): A Phase II Study Evaluating the Safety and Efficacy of Ranibizumab versus Focal Laser Treatment in Patients With Diabetic Macular Edema. Invest. Ophthalmol. Vis. Sci. 2007;48(13):1431.
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Diabetic macular edema (DME) is characterized by central retinal swelling caused by leakage from retinal vessels damaged by multiple factors, including high blood glucose levels. When it occurs in or near the fovea, DME can cause visual loss. There is an unmet clinical need in DME wherein 25% of patients receiving laser photocoagulation for DME still experience ≥15-letter loss of vision over a 3-year period. Ranibizumab (LucentisTM), a humanized antigen-binding antibody fragment, inhibits all known isoforms and active cleavage products of vascular endothelial growth factor A (VEGF-A), which increases vascular permeability and has been implicated in the pathogenesis of DME. This study compares the efficacy of monthly intravitreal (ITV) injections of ranibizumab with focal laser treatment in patients with DME.
In this ongoing single-center, open-label, 12-month trial, 60 DME patients will be randomized in a 2:1 ratio to receive either 3 monthly ITV injections of 0.5 mg ranibizumab or standard focal laser therapy, after which further treatments are at the physician’s discretion. The primary endpoint is the percentage of patients losing <15 letters of best-corrected ETDRS visual acuity (BCVA) from baseline. The secondary endpoint is the percent change in retinal thickening (central or noncentral) from baseline as measured by optical coherence tomography (OCT).
To date, 20 patients have been enrolled, including 14 in the ranibizumab arm (mean follow-up, 2.2 months) and 6 in the laser arm (mean follow-up, 3 months). At 3 months of follow-up, the mean change in BCVA was +4.2 letters in the ranibizumab arm (n = 6) and -2.0 letters in the laser arm (n = 4). Central retinal thickness decreased by a mean of 62.2 µm and 28.5 µm in the ranibizumab and laser arms, respectively. No significant safety concerns were identified.
The preliminary data from this study suggest that ranibizumab may be more effective than focal laser treatment at stabilizing or improving vision and decreasing retinal thickness in patients with DME.
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