An 8-week Phase II, Multicenter, Randomized, Double-masked, Vehicle Controlled Parallel Group Study With a 24 or 32 Week Follow-up Period to Evaluate the Efficacy of a Formulation Containing Anti-oxidant of Recombinant Human Nerve Growth Factor (rhNGF) 20 µg/ml, Eye Drops Solution Versus Vehicle Containing Anti-oxidant in Patients With Stage 2 and 3 Neurotrophic Keratitis

Trial Profile

An 8-week Phase II, Multicenter, Randomized, Double-masked, Vehicle Controlled Parallel Group Study With a 24 or 32 Week Follow-up Period to Evaluate the Efficacy of a Formulation Containing Anti-oxidant of Recombinant Human Nerve Growth Factor (rhNGF) 20 µg/ml, Eye Drops Solution Versus Vehicle Containing Anti-oxidant in Patients With Stage 2 and 3 Neurotrophic Keratitis

Recruiting
Phase of Trial: Phase II

Latest Information Update: 03 Aug 2017

At a glance

  • Drugs Cenegermin (Primary)
  • Indications Keratitis
  • Focus Therapeutic Use
  • Sponsors Dompe Spa
  • Most Recent Events

    • 20 Jul 2017 According to a Dompe media release, based on the data from this and another trial (see profile 243143) 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 243143) 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
    • 19 May 2017 According to a European Medicines Agency media release, based on the data from this and another trial CTP700243143 the European Medicines Agency (EMA) has recommended granting a marketing authorisation in the European Union (EU) for Oxervate (cenegermin) for the treatment of moderate or severe neurotrophic keratitis.
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