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 ]
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