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T. Missotten, G. S. Baarsma, R. W. A. M. Kuijpers, P. M. van Hagen; Somatostatin Analog for the Treatment of Exsudative Age Related Macular Degeneration: A Randomised Trial. Invest. Ophthalmol. Vis. Sci. 2007;48(13):4557.
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Somatostatin and some of its analogues have anti-angiogenic and anti-inflammatory properties, and have a clinical macular edema reducing effect. The combination of these properties form an ideal therapeutic profile for the treatment of age related macular degeneration, especially the exsudative type.
In 2000, before the introduction of anti-angiogenic intravitreal injections, a randomised double blind study comparing the Somatostatin analogue Octreotide-LAR with placebo therapy was performed. Informed consent was obtained from 96 patients with subfoveal exsudative macular degeneration. Patients received intramuscular injections at monthly intervals for 6 months of 20 mg of Octreotide-LAR or placebo. Visual acuity and lesion characteristics were analysed by standardised ETDRS measurements, fluorescein and ICG angiograms. Follow up was continued for an additional 6 months. Repeated analyses of IGF-1 and Octreotide serum levels were obtained.
43 of 48 patients in the treatment group and 41 of 48 patients in the placebo group completed the study. At onset 53.5% and 53.7% of CNV were (predominantly) classic at onset, and 46.5% and 46.3% were minimally classic in the treatment and placebo groups respectively. Initial Visual Acuity (logMar) was 0.53 and 0.57 in treatment and placebo respectively. No statistical significant difference could be found at the 6 month (end of treatment) and 1 year (end of follow up) points for visual acuity, loss of ETDRS letters or lesion size. Subgroup analysis according to lesion type was not significant either. No correlation between serologic IGF-1 and octreotide could be obtained. In a substantial group of treated patients, no therapeutic octreotide levels could be observed.
Although somatostatin and its analogues have an ideal profile for the treatment of exsudative AMD, this randomised placebo controlled double blind study with Octreotide-LAR did not show significant differences in visual acuity and lesion size outcome. The lack of significant octreotide serum levels in some patients could explain the result. Higher dosages, or alternative ways of administration e.g. intravitreous injection of somatostatin analogues could provide a solution for the observed pharmacokinetic problems.
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