title: Randomized clinical trial France DMLA2: effect of trimetazidine on exudative and nonexudative age-relatedmacular degeneration.
abstract: OBJECTIVE
  To evaluate the effect of trimetazidine (TMZ) in a randomized, double-blind, placebo-controlled clinical trial on the occurrence of choroidal neovascularization or geographic atrophy in age-related macular degeneration.
  
  
  METHODS
  A total of 1,086 patients from France, Belgium, and Spain with soft drusen and/or retinal pigment epithelium abnormalities in the study eye and choroidal neovascularization in the contralateral eye were randomly assigned to receive orally placebo or TMZ 70 mg daily (35 mg × 2) and followed-up for 3 years to 5 years.
  
  
  RESULTS
  Treatment duration ranged between 0.4 months and 67.8 months with a mean ± SD of 38 ± 16 months. Three hundred and fifty-eight patients developed choroidal neovascularization (incidence per 100 patient-years: TMZ 10.86; placebo 11.13). Trimetazidine did not prevent the choroidal neovascularization (hazard ratio = 0.97; 95% confidence interval, 0.77-1.20; P = 0.781). However, there was a trend favoring TMZ for retinal atrophy, a secondary endpoint (HR = 0.76; 95% confidence interval, 0.56-1.02; P = 0.069). Overall, the difference in atrophy incidence between TMZ and placebo was not statistically different. Differences within some prespecified subgroups of patients showed superiority of TMZ in men (HR = 0.50; 95% confidence interval, 0.28-0.89; p = 0.016), in patients aged ≤75 years (HR = 0.58; 95% confidence interval, 0.38-0.88; p = 0.010), or in patients presenting with isolated pigmentary changes (HR = 0.19; 95% confidence interval, 0.05-0.70; p = 0.005).
  
  
  CONCLUSIONS
  Trimetazidine failed to prevent choroidal neovascularization. Subgroup analyses suggest that this drug could be tested as preventive therapy for geographic atrophy, although the overall comparison showed no statistically significant differences in the progression of geographic atrophy.
authors.affiliation: Ophthalmic Center for Imaging and Laser, Paris, France. sycsyc75@gmail.com
authors.forename: Salomon-Yves
authors.initials: SY
authors.lastname: Cohen
authors.forename: Hubert
authors.initials: H
authors.lastname: Bourgeois
authors.forename: Christian
authors.initials: C
authors.lastname: Corbe
authors.forename: Gilles
authors.initials: G
authors.lastname: Chaine
authors.forename: Marie-Andrée
authors.initials: MA
authors.lastname: Espinasse-Berrod
authors.forename: Julian
authors.initials: J
authors.lastname: Garcia-Sanchez
authors.forename: Alain
authors.initials: A
authors.lastname: Gaudric
authors.forename: Alain
authors.initials: A
authors.lastname: Hullo
authors.forename: Anita
authors.initials: A
authors.lastname: Leys
authors.forename: Gisèle
authors.initials: G
authors.lastname: Soubrane
authors.forename: Joséa
authors.initials: J
authors.lastname: Sahel
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001530:Belgium; D020256:Choroidal Neovascularization / Q000517:prevention & control; D004311:Double-Blind Method; D005122:Exudates and Transudates; D005260:Female; D005500:Follow-Up Studies; D005602:France; D006801:Humans; D008268:Macular Degeneration / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D013030:Spain; D014292:Trimetazidine / Q000627:therapeutic use*; D014665:Vasodilator Agents / Q000627:therapeutic use*
chemical_list: D014665:Vasodilator Agents; D014292:Trimetazidine