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J. Feher, B. Kovacs, I. Kovacs, M. Schvoller, A. Papale, G. Mannino, C. Balacco Gabrieli, Ophthalmic Neuroscience Program; Mitotrop Compounds for the Treatment of Early Age-Related Macular Degeneration: The Metabolic Approach and a Clinical Trial . Invest. Ophthalmol. Vis. Sci. 2003;44(13):5031.
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Purpose: Our previous studies showed that mitochondria and peroxisomes of the retinal pigment epithelium (RPE) may play a central role in the pathophysiology of Age-related Macular Degeneration (AMD). The aim of the present study was to test the pharmacological efficacy of certain compounds which influence mitochondrial metabolism (mitochondriotrop or mitotrop compounds) on early AMD. Methods: We have performed a randomized, placebo-controlled, double blind, single center study designed to compare the efficacy and safety of a food supplementary compound HS126.3 (acetyl-L-carnitine, highly concentrated omega-3 and coenzyme Q10) and placebo in 106 patients affected by early AMD during twelve months of treatment. The primary objective of this study was to determine whether patients treated with HS126.3 show a slower progression of the pathology after 12 months of treatment compared with placebo-treated patients with early AMD. The primary response criterion for efficacy was the change of the central 10° visual field mean defect (MD) between screening and 12 months Results: (i) There was no significant difference between the treatment groups at screening. (ii) There was a significant improvement in the placebo group at Day 180 (p=0.013), but a non-significant deterioration at Day 360.(iii)There was a significant improvement in the HS 126.3 group at Day 180 (p<0.001), Day 360 (p=0.024) and the last visit (p=0.027). (iv) There is no significant difference between groups at any time point although there is a trend at Day 360 (p=0.07).(v) This pattern is repeated in the patients aged 60 and over, with no significant change in the placebo group but a significant improvement at each visit in the HS126.3 group. Conclusions: All these findings justify an assumption that an appropriate association of mitotrop compounds may improve visual functions in early AMD. The metabolic approach seems to influence a currently incurable neurodegenerative disease like ADM. Further studies are certainly needed to demonstrate long term benefits of this treatment.
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