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S.M. Shah, J.A. Haller, P.A. Campochiaro, A. Polito, Q.D. Nguyen, S. Vitale; A Randomized, Prospective, Controlled Clinical Trial of Sandostatin LAR depot in Patients with Cystoid Macular Edema . Invest. Ophthalmol. Vis. Sci. 2003;44(13):4310.
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Purpose: To evaluate the safety and efficacy of Sandostatin LAR (octreotide, an IGF-1 and GH antagonist) for treatment of CME. Design: Randomized, prospective, double masked, placebo controlled clinical trial. Methods: 22 patients (mean age: 66 yrs, F= 15) with chronic refractory postoperative cystoid macular edema were randomized to Sandostatin LAR 30mg IM monthly for six months or saline placebo. Inclusion criteria included VA≤ 20/40 and clinical, angiographic and OCT evidence of CME. Exclusion criteria included pre-existing gallstones(by ultrasound) and other significant ocular disease. Main outcome measures: Clinical exam, visual acuity, retinal thickness on OCT, and FA. Results: There was no difference between cases and controls at baseline and month 6 in retinal volume (p=0.9 and 0.3 respectively, Mann Whitney Ranksum Test), mean central one mm foveal thickness (p= 0.6 and 0.1 respectively) and foveolar thickness (p=0.7 and 0.1 respectively). There was no difference between groups in baseline VA (p=0.2), however, by month 6, there was a statistically significant difference in VA between cases and controls (p=.01). There was no significant difference between groups on the basis of FA, although individual cases showed improvement. Conclusion: Inhibitors of IGF-1 and GH activity have a potential application in the treatment of ocular disorders caused by increased vascular permeability including macular edema and neovascularization. This trial shows an association between the use of Sandostatin LAR and visual improvement in patients with chronic CME. Further study with larger numbers is required to confirm a treatment benefit.
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