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An 8-week Phase I/II, Multicenter, Randomized, Double-masked, Vehicle Controlled Parallel Group Study With a 48 or 56 Week Follow-up Period to Evaluate the Safety and Efficacy of Two Doses (10 µg/ml and 20 µg/ml) of Recombinant Human Nerve Growth Factor Eye Drops Solution Versus Vehicle in Patients With Stage 2 and 3 of Neurotrophic Keratitis

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Trial Profile

An 8-week Phase I/II, Multicenter, Randomized, Double-masked, Vehicle Controlled Parallel Group Study With a 48 or 56 Week Follow-up Period to Evaluate the Safety and Efficacy of Two Doses (10 µg/ml and 20 µg/ml) of Recombinant Human Nerve Growth Factor Eye Drops Solution Versus Vehicle in Patients With Stage 2 and 3 of Neurotrophic Keratitis

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 05 Apr 2022

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At a glance

  • Drugs Cenegermin (Primary)
  • Indications Corneal ulcer; Keratitis
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms REPARO
  • Sponsors Dompe Farmaceutici; Dompe Spa

Most Recent Events

  • 22 Aug 2018 According to a Dompe media release, the U.S. Food and Drug Administration (FDA) has approved Oxervate (cenegermin-bkbj ophthalmic solution) for the treatment of neurotrophic keratitis (NK).
  • 20 Jul 2017 According to a Dompe media release, based on the data from this and another trial (see profile 248755) the European Commission has granted the marketing authorisation for cenegermin eye drops for the treatment of adult patients with moderate or severe neurotrophic keratitis.
  • 23 May 2017 According to a Dompe media release, based on the data (n=204) from this and other trial (see profile 248755) the Committee for Human Medicinal Products (CHMP) of EMA (European Medicines Agency) has released a positive opinion, recommending the marketing authorization for Oxervate (cenegermin eye drops), for the treatment of adult patients with moderate or severe neurotrophic keratitis.

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