May 2008
Volume 49, Issue 13
Free
ARVO Annual Meeting Abstract  |   May 2008
Drug Effects on Neovascularisation and on Atrophy Are Differents in AMD : Results of FRANCE DMLA 2 Study
Author Affiliations & Notes
  • G. Chaine
    Hospital Avicenne, Bobigny, France
  • S. Cohen
    Hospital Lariboisière, Paris, France
  • C. Corbé
    Institution Nationale des Invalides, Paris, France
  • M.-A. Espinasse-Berrod
    Hospital Necker, Paris, France
  • J. Garcia-Sanchez
    Hospital Clinico San Carlos, Madrid, Spain
  • A. Gaudric
    Hospital Lariboisière, Paris, France
  • A. Hullo
    Hospital Lyon Sud, Lyon, France
  • A. Leys
    Oogheelkunde St Raphael Hospital, Leuven, Belgium
  • J. Sahel
    Hospital Quinze Vingts, Paris, France
  • G. Soubrane
    Centre Hospitalier Intercommunal, Créteil, France
  • Footnotes
    Commercial Relationships  G. Chaine, None; S. Cohen, None; C. Corbé, None; M. Espinasse-Berrod, Servier, E; J. Garcia-Sanchez, None; A. Gaudric, None; A. Hullo, None; A. Leys, None; J. Sahel, None; G. Soubrane, None.
  • Footnotes
    Support  None.
Investigative Ophthalmology & Visual Science May 2008, Vol.49, 5579. doi:https://doi.org/
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      G. Chaine, S. Cohen, C. Corbé, M.-A. Espinasse-Berrod, J. Garcia-Sanchez, A. Gaudric, A. Hullo, A. Leys, J. Sahel, G. Soubrane; Drug Effects on Neovascularisation and on Atrophy Are Differents in AMD : Results of FRANCE DMLA 2 Study. Invest. Ophthalmol. Vis. Sci. 2008;49(13):5579. doi: https://doi.org/.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose: : To evaluate the effect of trimetazidine 35 mg (TMZ) on the emergence of choroidal neovascularisation (primary criteria) or geographic atrophy (GA) and on the evolution of angiographic semiology in AMD.

Methods: : 1086 patients (416 men, mean age 74) from France, Belgium and Spain were randomized in a double blind study to placebo (P) or trimetazidine 35 mg twice a day (TMZ), during a median follow up of 38 months. All patients presented soft drusen or retinal pigment epithelium (RPE) abnormalities on the evaluated eye and a neovascular form of AMD on the controlateral eye. A reviewing committee performed double-blind analysis of initial and follow up angiographies.

Results: : 358 patients developed neovascularisation during the study (TMZ: 181 - P: 177).The incidence per 100 patient-years of neovascularisation was 10.86 (TMZ) vs 11.13 (P) (NS). A surface atrophy exceeding 1/3 of the papillary diameter of the evaluated eye was detected in 171 patients (TMZ: 78 - P: 93). The incidence per 100 patient-years of GA was 5.11 (TMZ) vs 6.45 (P) (p=0.069). Statistical significant results are found among men (p=0.016 -TMZ vs P), patients below 75 years old (p=0.01) and patients presenting any pigmentary abnormalities at inclusion (p=0.005), depigmentation (p=0.01), or hyperpigmentation (p=0.044). Tolerance was good.

Conclusions: : The physiopathogeny of AMD might be due to blood flow decrease to the choriocapillaris, to rarefaction of this choriocapillaris and/or to tissue hypoxia. Besides, coronary artery diseases seem to be associated to the most advanced form of AMD. Therefore, it was particularly interesting to perform a study with an antiischemic drug such as TMZ, in order to assess the importance of ischemic phenomenon in the worsening of AMD and its different evolving forms. The antiischemic TMZ did not confirm its potential to prevent neovascularisation bilateralization in AMD. However, data strongly suggest that TMZ exerts a protective effect in preventing GA.

Keywords: age-related macular degeneration • clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • ischemia 
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