A Phase 2, Randomized, Active-Controlled, Double-Masked, Multi-Center Study to Assess the Safety and Efficacy of Daily Subcutaneous AKB-9778 Administered for 3 Months, as Monotherapy or Adjunctive to Ranibizumab, in Subjects With Diabetic Macular Edema

Trial Profile

A Phase 2, Randomized, Active-Controlled, Double-Masked, Multi-Center Study to Assess the Safety and Efficacy of Daily Subcutaneous AKB-9778 Administered for 3 Months, as Monotherapy or Adjunctive to Ranibizumab, in Subjects With Diabetic Macular Edema

Completed
Phase of Trial: Phase II

Latest Information Update: 20 Mar 2017

At a glance

  • Drugs AKB 9778 (Primary) ; Ranibizumab
  • Indications Diabetic macular oedema
  • Focus Proof of concept; Therapeutic Use
  • Acronyms TIME-2
  • Sponsors Aerpio Therapeutics
  • Most Recent Events

    • 13 Jun 2016 Results from this trial have been published in Ophthalmology and were presented at the American Academy of Ophthalmology Annual Meeting (November, 2015), according to an Aerpio Therapeutics media release.
    • 13 Jun 2016 Results published in an Aerpio Therapeutics media release.
    • 13 Jun 2016 Primary endpoint (Mean change from baseline in spectral domain optical coherence tomography (sdOCT)-measured central subfield thickness (CST)) has been met, according to an Aerpio Therapeutics media release.
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