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Clinical efficacy of eplerenone versus placebo for central serous chorioretinopathy: study protocol for the VICI randomised controlled trial.

Abby WillcoxLucy CullifordLucy EllisChris A RogersAngela Jane CreeUsha ChakravarthySarah EnnisFrancine Behar-CohenBarnaby C ReevesSobha SivaprasadAndrew John Lotery
Published in: Eye (London, England) (2018)
Recruitment is complete but was slower than expected. We maintained the eligibility criteria to ensure participants had 'true' CSCR and recruited additional centres. Effective distribution of the investigational medicinal product (IMP) was achieved by implementing a database to manage ordering and accountability of IMP packs. The results will provide adequately powered evidence to inform clinical decisions about using eplerenone to treat patients with CSCR.
Keyphrases
  • high grade
  • study protocol
  • quality improvement
  • adverse drug
  • phase ii
  • randomized controlled trial
  • phase iii
  • open label
  • electronic health record