Treatment of non-infectious retinal vasculitis using subcutaneous repository corticotropin injection

Abstract

Purpose : Non-infectious retinal vasculitis (RV) is a severe and sight-threatening condition that may present alone or in association with other ocular inflammation, typically requiring immunosuppressive therapy to help bring it under control. This proof-of-concept study aimed to show whether subcutaneous Acthar Gel, a repository corticotropin injection (RCI), can be a safe and effective novel potential therapeutic agent for retinal vasculitis.

Methods : Patients with active retinal vasculitis were treated with 80 units of subcutaneous RCI twice weekly and followed with serial ultra-widefield fluorescein angiography. Patients currently or previously treated with systemic corticosteroid 6 weeks prior to enrollment were excluded. Subjects on non-steroidal immunosuppressive therapy were required to have a stable dose for 6 weeks prior to entering the study.

Results : Eighteen patients (30 eyes) were followed over 24 weeks with 9 patients (14 eyes) able to complete the study without protocol deviation. Any improvement in RV was seen in 90.0% of 30 total eyes at a mean time of 2.9 weeks. Mean response level (RL) at the 2, 4, 8, 12, and 24-week visits in per-protocol eyes was 12.1%, 33.9%, 41.3%, 52.2%, and 74.1% respectively (p ≤ 0.0002). Improvement to 50% or more by week 12 was seen in 50.0% of these eyes, with 26.7% achieving complete resolution of RV in a mean time of 15.5 weeks. No significant adverse events were seen.

Conclusions : RCI may be an effective therapeutic agent in the treatment of non-infectious RV. RCI was felt to be well tolerated. This study also introduces a novel means by which to evaluate RV activity.

This is a 2020 ARVO Annual Meeting abstract.

 

Fluorescein angiography of per protocol study eyes (A-F) demonstrating changes in retinal vasculitis and generalized inflammation from week 0 (baseline) to week 12 to week 24. Of note, varying levels of improvement were seen, from mild to moderate to complete resolution by week 24.

 

Percentage of per protocol population (PPP) eyes with varying response levels at each study visit after baseline.