Clinical Trial: Efficacy and Safety of H.P. ACTHAR GEL in Adults With Retinal Vasculitis

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Open-label, Single-center, Prospective Study on the Efficacy and Safety of Repository Corticotropin Injection (H.P. ACTHAR GEL) in the Treatment of Adults With Non-infectious Ret

Brief Summary: The purpose of this study is to evaluate the short- and long-term efficacy and safety of Acthar for the treatment of adults with non-infectious retinal vasculitis.

Detailed Summary:
Sponsor: Ocular Immunology and Uveitis Foundation

Current Primary Outcome: Percentage of responders to Acthar at the end of treatment. [ Time Frame: 24 Weeks ]

A responder will be defined by the binominal presence or absence of active retinal vasculitis as evaluated at Week 24. Active retinal vasculitis is defined as angiographic leakage from retinal arterioles, venules, or capillaries as determined by investigator, seen on wide-field angiography. Complete resolution or absence of active retinal vasculitis at Week 24 is considered success or "remission".


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Presence or absence of active retinal vasculitis at all other time points. [ Time Frame: 1 Day to 24 Weeks ]
  • Safety assessments, including drug tolerability and adverse events; other ocular and/or systemic complications. [ Time Frame: 1 Day to 24 Weeks ]
  • Percentage of patients requiring rescue therapy. [ Time Frame: 1 Day to 24 Weeks ]


Original Secondary Outcome: Same as current

Information By: Ocular Immunology and Uveitis Foundation

Dates:
Date Received: December 30, 2016
Date Started: March 2017
Date Completion: June 2018
Last Updated: March 6, 2017
Last Verified: March 2017