Clinical Trials Logo

Clinical Trial Summary

Uveitis represents a heterogeneous group of diseases that results from ocular inflammatory reaction involving ocular tissue and vasculature. The inflammation usually causes pain, redness, photophobia and blurred vision. This inflammation, is typically treated with regional or systemic therapy. The regional therapy typically consists of topical corticosteroids or periocular or regional corticosteroids. Regional therapy can lead to a steroid response glaucoma, which is increased intraocular pressure.This pilot study aims to evaluate the possible effectiveness of H.P. Acthar in patients with active ocular inflammatory disease, and currently on treatment for glaucoma or have a history of glaucoma.


Clinical Trial Description

Uveitis represents a heterogeneous group of diseases that results from ocular inflammatory reaction involving ocular tissue and vasculature. The inflammation usually causes pain, redness, photophobia and blurred vision.

H.P Acthar Gel stimulate the adrenal cortex to secrete cortisol. Additionally H.P. Acthar gel is also reported to bind to melanocortin receptors. Melanocortin receptor activation has been shown to exert marked anti-inflammatory and immune-modulatory effects in animal studies, by modulating pro inflammatory cytokines, followed by induction of anti- inflammatory mediators and subsequent leukocyte migration. Specifically melanocortins down regulate Tumor Necrosis Factor (TNF) alpha, Interleukin (IL) -2, Interferon gamma and T-cell proliferation and upregulates IL-10 and regulatory T cells. For this reason H.P. Acthar is an approved treatment for ocular inflammatory disease.

Ocular inflammatory disease is typically treated with regional or systemic therapy. The regional therapy typically consists of topical corticosteroids or periocular or regional corticosteroids. Regional therapy can lead to a steroid response glaucoma, which is increased intraocular pressure.This pilot study aims to evaluate the possible effectiveness of H.P. Acthar in patients with active ocular inflammatory disease, and currently on treatment for glaucoma or have a history of glaucoma.

Subjects will be treated with H P Acthar subcutaneous gel, 40 U/ml, given twice weekly x 8 weeks, followed by once weekly x 4 weeks: a total 20 doses with the same cumulative units to be administered, using the approved route, with the option to do 4 additional doses if resolution is incomplete.

This will be a prospective open-label, non-randomized pilot study: 12 week treatment for active non-infectious uveitis, endpoint assessment and safety assessment; additional 12 week assessment for uveitis activity/quiescence and safety assessment. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02764697
Study type Interventional
Source Tampa Bay Uveitis Center, LLC
Contact
Status Completed
Phase Phase 4
Start date June 30, 2016
Completion date December 20, 2016

See also
  Status Clinical Trial Phase
Recruiting NCT04101604 - Biomarkers of Common Eye Diseases
Active, not recruiting NCT04704609 - Imaging Quantification of Inflammation (IQI)
Completed NCT03173144 - Chronic Inflammatory Disease, Lifestyle and Treatment Response
Withdrawn NCT01280669 - Intravitreal Sirolimus as Therapeutic Approach to Uveitis Phase 2
Terminated NCT02907814 - Measurement of Anterior Chamber Cell Grading Using Ocular Coherence Tomography N/A
Active, not recruiting NCT02252328 - Use of Simvastatin as a Steroid Sparing Agent for Uveitis Patients Phase 2/Phase 3
Completed NCT04183387 - Simvastatin in Uveitis Phase 2
Completed NCT01983488 - Clinical Outcome in Uveitis
Withdrawn NCT00499551 - A Phase I/IIa Study for the Treatment of Uveitis With Iontophoresis Phase 1/Phase 2
Completed NCT00132691 - Multicenter Uveitis Steroid Treatment (MUST) Trial Phase 4
Completed NCT00476593 - Retinal OCT and (mfERG) Related to Age, Sex, and the Use of Anti-inflammatory Medications N/A
Terminated NCT00114062 - Study to Treat Uveitis Associated Macular Edema Phase 2
Completed NCT00001867 - Effect of Pregnancy on Uveitis N/A
Completed NCT00379275 - Eye and Immunogenetic Features of Sarcoidosis N/A
Active, not recruiting NCT03828019 - Adalimumab vs. Conventional Immunosuppression for Uveitis Trial Phase 3
Terminated NCT01939691 - Macular Edema Nepafenac vs. Difluprednate Uveitis Trial Phase 4
Active, not recruiting NCT03889860 - Objective Choroidal Thickness Measurements in Uveitis
Completed NCT00070759 - Daclizumab to Treat Non-Infectious Sight-Threatening Uveitis Phase 2
Recruiting NCT05486468 - The Use of Two YUTIQ Versus Sham for Treatment of Chronic Non Infectious Intraocular Inflammation Affecting the Posterior Segment Phase 3
Active, not recruiting NCT05385757 - UNICORNS: Uveitis in Childhood Prospective National Cohort Study