title: Alprostadil infusion in patients with dry age related macular degeneration: a randomized controlled clinical trial.
abstract: BACKGROUND
  Age-related macular degeneration is the leading cause of blindness among elderly individuals in industrialized countries. New drugs and advanced concepts for the treatment of dry AMD (dAMD) are needed. A new approach is the application of intravenous infusions of prostaglandin E1.
  
  
  OBJECTIVE
  The aim of this study was to assess efficacy and safety of intravenous alprostadil infusion in patients with dAMD.
  
  
  METHODS
  This was a prospective, randomized, multi-center study. Patients were treated with intravenous infusion of either 60 µg alprostadil or placebo over 3 weeks. Main efficacy outcomes were mean differences in best corrected visual acuity (BCVA) from baseline assessed in early treatment diabetic retinopathy study (ETDRS) lines immediately, 3 months and 6 months after treatment.
  
  
  RESULTS
  In the full analysis set (FAS) a mean difference of 0.89 ± 0.537 ETDRS lines according to analysis of variance-covariance (ANCOVA) resulted in the alprostadil group (n = 16) and a mean difference of -0.05 ± 0.578 in the placebo group (n = 17) 3 months after end of treatment. Thus, effectiveness of alprostadil infusion was numerically superior to placebo treatment by a mean of 0.94 lines after 3 months (1.51 lines after 6 months). These findings were more pronounced in the per protocol set (PPS). Safety results were in line with the good safety profile of alprostadil.
  
  
  CONCLUSIONS
  A numerical treatment effect in favor of alprostadil was visible, which lasted until the end of follow up. These results provide further evidence that alprostadil probably has a therapeutic effect in the treatment of dAMD and justify further clinical studies.
authors.affiliation: Direktor der Augenklinik, Klinikum Karlsruhe , Moltkestrasse 90, 76133 Karlsruhe, Germany. albertjaugustin@googlemail.com
authors.forename: Albert J
authors.initials: AJ
authors.lastname: Augustin
authors.forename: Curt
authors.initials: C
authors.lastname: Diehm
authors.forename: Frank
authors.initials: F
authors.lastname: Grieger
authors.forename: Juergen
authors.initials: J
authors.lastname: Bentz
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000527:Alprostadil / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001317:Austria; D004311:Double-Blind Method; D005260:Female; D057092:Geographic Atrophy / Q000188:drug therapy* / Q000503:physiopathology; D005858:Germany; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D009887:Ophthalmoscopy; D011446:Prospective Studies; D013997:Time Factors; D016896:Treatment Outcome; D014665:Vasodilator Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D014792:Visual Acuity / Q000187:drug effects*
chemical_list: D014665:Vasodilator Agents; D000527:Alprostadil