Clinical Trial: Safety and Efficacy Study of RPh201 Treatment of Ischemic Optic Neuropathy (ION).

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Preliminary Double Blind Clinical Study, Efficacy Study of RPh201 Treatment of Ischemic Optic Neuropathy (ION).

Brief Summary: The study objectives are to assess any changes in visual acuity and visual field observed following the administration of RPh201 during an overall treatment period of at least 13 consecutive weeks with an option to extended the treatment phase to another 13 weeks (26 weeks total), and at the follow-up visit at 3 month after end of treatment in patients with optic nerve neuropathy.

Detailed Summary:
Sponsor: Regenera Pharma Ltd

Current Primary Outcome: To assess any changes in visual acuity and visual field observed following the treatment [ Time Frame: 26/39 weeks ]

The primary endpoints of this study are to assess any changes in visual acuity and visual field observed following the subcutaneous (SC) administration of RPh201 an overall treatment period of up to 13/26 weeks and at the follow-up visit at 3 month after end of treatment:

  • To assess any changes in visual acuity and visual field observed following the SC administration of RPh201
  • To assess any changes in Visual Evoked Potential observed following the SC administration of RPh201
  • To assess any changes in Optical Coherence Tomography (OCT) observed following the SC administration of RPh201


Original Primary Outcome: Same as current

Current Secondary Outcome: To demonstrate safety and tolerability of multiple SC doses of RPh201 [ Time Frame: 26/39 weeks ]

Safety and tolerability multiple ascending SC doses as assessed by adverse events, vital signs, clinical laboratory and physical exam


Original Secondary Outcome: Same as current

Information By: Regenera Pharma Ltd

Dates:
Date Received: January 21, 2014
Date Started: February 2014
Date Completion:
Last Updated: December 5, 2016
Last Verified: December 2016