title: Long-term outcomes of phakic patients with diabetic macular oedema treated with intravitreal fluocinolone acetonide (FAc) implants.
abstract: OBJECTIVE
  Diabetic macular oedema (DMO) is a leading cause of blindness in working-age adults. Slow-release, nonbioerodible fluocinolone acetonide (FAc) implants have shown efficacy in the treatment of DMO; however, the National Institute for Health and Care Excellence recommends that FAc should be used in patients with chronic DMO considered insufficiently responsive to other available therapies only if the eye to be treated is pseudophakic. The goal of this analysis was to examine treatment outcomes in phakic patients who received 0.2 μg/day FAc implant.
  
  
  METHODS
  This analysis of the phase 3 FAME (Fluocinolone Acetonide in Diabetic Macular Edema) data examines the safety and efficacy of FAc implants in patients who underwent cataract extraction before (cataract before implant (CBI) group) or after (cataract after implant (CAI) group) receiving the implant. The data were further examined by DMO duration.
  
  
  RESULTS
  Best corrected visual acuity (BCVA) after 36 months was comparable in the CAI and CBI groups. Both the percentage of patients gaining ≥ 3 lines of vision and mean change in BCVA letter score were numerically greater in the CAI group. In addition, most patients who underwent cataract surgery experienced a net gain in BCVA from presurgery baseline as well as from original study baseline.
  
  
  CONCLUSIONS
  These data support the use of 0.2 μg/day FAc implants in phakic as well as in pseudophakic patients. These findings will serve as a pilot for design of future studies to evaluate the potential protective effect of FAc implants before cataract surgery in patients with DMO and cataract.
authors.affiliation: Royal Wolverhampton Hospitals NHS Trust, Wolverhampton, UK.
authors.forename: Y
authors.initials: Y
authors.lastname: Yang
authors.affiliation: University Hospitals Bristol NHS Foundation Trust, Bristol, UK.
authors.forename: C
authors.initials: C
authors.lastname: Bailey
authors.affiliation: University of Bonn, Bonn, Germany.
authors.forename: F G
authors.initials: FG
authors.lastname: Holz
authors.affiliation: University of Muenster Medical Center, Muenster, Germany.
authors.forename: N
authors.initials: N
authors.lastname: Eter
authors.affiliation: University Hospital of Nantes, Nantes, France.
authors.forename: M
authors.initials: M
authors.lastname: Weber
authors.affiliation: Paducah Retinal Center, Paducah, KY, USA.
authors.forename: C
authors.initials: C
authors.lastname: Baker
authors.affiliation: Weill Cornell Medical College, New York, NY, USA.
authors.forename: S
authors.initials: S
authors.lastname: Kiss
authors.affiliation: Università degli Studi di Firenze, Firenze, Italy.
authors.forename: U
authors.initials: U
authors.lastname: Menchini
authors.affiliation: University Castilla La Mancha, Albacete, Spain.
authors.forename: J M
authors.initials: JM
authors.lastname: Ruiz Moreno
authors.affiliation: Retinal Consultants of Arizona, Phoenix, AZ, USA.
authors.forename: P
authors.initials: P
authors.lastname: Dugel
authors.affiliation: University of Southampton, Southampton, UK.
authors.forename: A
authors.initials: A
authors.lastname: Lotery
mesh_terms: D000328:Adult; D000368:Aged; D003692:Delayed-Action Preparations / Q000008:administration & dosage*; D003930:Diabetic Retinopathy / Q000188:drug therapy*; D004343:Drug Implants; D005260:Female; D005446:Fluocinolone Acetonide / Q000008:administration & dosage*; D005500:Follow-Up Studies; D005938:Glucocorticoids / Q000008:administration & dosage*; D006801:Humans; D008269:Macular Edema / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D019591:Pseudophakia / Q000188:drug therapy*; D014792:Visual Acuity
chemical_list: D003692:Delayed-Action Preparations; D004343:Drug Implants; D005938:Glucocorticoids; D005446:Fluocinolone Acetonide