title: Improvement of visual functions and fundus alterations in early age-related macular degeneration treated with a combination of acetyl-L-carnitine, n-3 fatty acids, and coenzyme Q10.
abstract: The aim of this randomized, double-blind, placebo-controlled clinical trial was to determine the efficacy of a combination of acetyl-L-carnitine, n-3 fatty acids, and coenzyme Q10 (Phototrop) on the visual functions and fundus alterations in early age-related macular degeneration (AMD). One hundred and six patients with a clinical diagnosis of early AMD were randomized to the treated or control groups. The primary efficacy variable was the change in the visual field mean defect (VFMD) from baseline to 12 months of treatment, with secondary efficacy parameters: visual acuity (Snellen chart and ETDRS chart), foveal sensitivity as measured by perimetry, and fundus alterations as evaluated according to the criteria of the International Classification and Grading System for AMD. The mean change in all four parameters of visual functions showed significant improvement in the treated group by the end of the study period. In addition, in the treated group only 1 out of 48 cases (2%) while in the placebo group 9 out of 53 (17%) showed clinically significant (>2.0 dB) worsening in VFMD (p = 0.006, odds ratio: 10.93). Decrease in drusen-covered area of treated eyes was also statistically significant as compared to placebo when either the most affected eyes (p = 0.045) or the less affected eyes (p = 0.017) were considered. These findings strongly suggested that an appropriate combination of compounds which affect mitochondrial lipid metabolism, may improve and subsequently stabilize visual functions, and it may also improve fundus alterations in patients affected by early AMD.
authors.affiliation: Ophthalmic Neuroscience Program, Department of Ophthalmology, University of Rome 'La Sapienza', Rome, Italy. j.feher@libero.it
authors.forename: J
authors.initials: J
authors.lastname: Feher
authors.forename: B
authors.initials: B
authors.lastname: Kovacs
authors.forename: I
authors.initials: I
authors.lastname: Kovacs
authors.forename: M
authors.initials: M
authors.lastname: Schveoller
authors.forename: A
authors.initials: A
authors.lastname: Papale
authors.forename: C
authors.initials: C
authors.lastname: Balacco Gabrieli
mesh_terms: D000108:Acetylcarnitine / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D003067:Coenzymes; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D015525:Fatty Acids, Omega-3 / Q000627:therapeutic use*; D005260:Female; D005654:Fundus Oculi; D006801:Humans; D008268:Macular Degeneration / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D016896:Treatment Outcome; D014451:Ubiquinone / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D014792:Visual Acuity / Q000187:drug effects*; D058609:Visual Field Tests
chemical_list: D003067:Coenzymes; D015525:Fatty Acids, Omega-3; D014451:Ubiquinone; D000108:Acetylcarnitine; C024989:coenzyme Q10