Effect of ruboxistaurin (RBX) On visual acuity decline over a 6-year period with cessation and reinstitution of therapy: results of an open-label extension of the Protein Kinase C Diabetic Retinopathy Study 2 (PKC-DRS2)

Matthew J Sheetz, Lloyd Paul Aiello, Nazila Shahri, Matthew D Davis, Keri A Kles, Ronald P Danis, Mbdv Study Group

29 Citations (Scopus)

Abstract

The PKC-DRS2 was a Phase 3, randomized, double-masked, placebo (PBO)-controlled, 3-year study of the effect of 32 mg/day of ruboxistaurin (RBX), an orally administered protein kinase C inhibitor, on vision loss in patients with moderate to severe nonproliferative diabetic retinopathy. Ruboxistaurin reduced the occurrence of sustained moderate visual loss (SMVL; ≥15-letter decline in visual acuity sustained for the last 6 months of study participation) from 9.1% in the PBO group (N = 340) to 5.5% in the RBX group (N = 345, P = 0.034). This study evaluates the primary end point of SMVL in a 2-year open-label extension (OLE) of the PKC-DRS2, which began a median of 466 days (range, 263-1,296 days) after the conclusion of PKC-DRS2.
Original languageEnglish
JournalRetina
Volume31
Issue number6
Pages (from-to)1053-9
Number of pages7
ISSN0275-004X
DOIs
Publication statusPublished - 2011

Keywords

  • Administration, Oral
  • Diabetic Retinopathy
  • Double-Blind Method
  • Enzyme Inhibitors
  • Female
  • Humans
  • Indoles
  • Male
  • Maleimides
  • Middle Aged
  • Protein Kinase C
  • Retreatment
  • Vision Disorders
  • Vision Tests
  • Visual Acuity
  • Withholding Treatment

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