OHR-1601: A Phase III Study of the Efficacy and Safety of Squalamine Lactate Ophthalmic Solution, 0.2% Twice Daily in Subjects With Neovascular Age-Related Macular Degeneration (AMD)

Trial Profile

OHR-1601: A Phase III Study of the Efficacy and Safety of Squalamine Lactate Ophthalmic Solution, 0.2% Twice Daily in Subjects With Neovascular Age-Related Macular Degeneration (AMD)

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 11 May 2017

At a glance

  • Drugs Squalamine (Primary) ; Ranibizumab
  • Indications Wet age-related macular degeneration
  • Focus Registrational; Therapeutic Use
  • Acronyms MAKO
  • Sponsors Ohr Pharmaceutical
  • Most Recent Events

    • 11 May 2017 According to an Ohr Pharmaceutical media release, the trial protocol has been amended to enable top-line data (efficacy analyses) by the end of calendar 2017 or early 2018. Patients enrolled in the study continue to receive their assigned study treatment of monthly Lucentis and either topical Squalamine or placebo twice daily, and undergo scheduled visits and assessments through nine months.
    • 25 Apr 2017 Planned End Date changed from 1 Apr 2019 to 1 Dec 2017.
    • 10 Apr 2017 According to an Ohr Pharmaceutical media release, the data safety monitoring board has confirmed that there are no safety concerns and recommended the study continue as planned.
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