Study of H.P. ACTHAR Subcutaneous Gelatin (Gel)(Highly Purified Gel Injection) in Uveitis Patients
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|ClinicalTrials.gov Identifier: NCT02764697|
Recruitment Status : Completed
First Posted : May 6, 2016
Last Update Posted : January 10, 2017
|Condition or disease||Intervention/treatment||Phase|
|Uveitis Anterior Uveitis Intermediate Uveitis Posterior Uveitis Scleritis Clinically Significant Macular Edema||Drug: H.P. ACTHAR SUBCUTANEOUS GEL INJECTION||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Open Label Study of H.P. Acthar Gel Injection in Patients With Active Non-Infectious Uveitis With Associated Glaucoma Thus High Frequency Regional Corticosteroid and Oral Corticosteroids Cause Intolerable Side-Effects|
|Study Start Date :||July 2016|
|Actual Primary Completion Date :||January 2017|
|Actual Study Completion Date :||January 2017|
H.P. Acthar Subcutaneous Gel Injection
For the current protocol we are proposing, 40 U/ml, given twice weekly x 8 weeks, followed by once weekly x 4 weeks: a total 20 doses, using the approved route, with the option to do 4 additional doses if resolution is incomplete.
Drug: H.P. ACTHAR SUBCUTANEOUS GEL INJECTION
Subcutaneous injection twice weekly
Other Name: Acthar
- Resolution of Inflammation: Anterior Uveitis [ Time Frame: 12 weeks ]2 step decrease in inflammatory score or down to grade 0 (Standardization of Uveitis Nomenclature, standardized and published for reporting clinical trials in uveitis:SUN criteria): Using the SUN criteria, inflammation can be graded on a scale from 0-4: subjects will be graded at baseline; resolution will graded as achieving the primary endpoint when the score decreases by 2 steps on the scale, or goes down to grade 0
- Resolution of Inflammation: Retinal Vasculitis [ Time Frame: 12 weeks ]Clinical improvement of vasculitis, corroborated by angiographic evaluation: subjects with retinal vasculitis will have a retinal angiogram called a fluorescein angiogram at baseline and week 12, this will document areas of retinal vascular inflammation: Resolution will be graded at 12 weeks based on retinal leakage resolution on the fluorescein angiogram
- Resolution of Inflammation:Intermediate Uveitis: Photographic haze reduced to grade 0 or down 2 steps documented with fundus photography [ Time Frame: 12 Weeks ]Subjects will have fundus photography at baseline and 12 weeks. Intermediate uveitis is graded by haze; it is done using the photographic scale: grades 0-4, utilized by the SUN criteria, based on the Nussenblatt photographic vitreous haze scale
- Resolution of Inflammation: Clinically Significant Uveitic Macular Edema: Clinical improvement of macular edema with optical coherence tomography (OCT), which measures retinal thickness; documentation of central foveal thickness < 300 microns [ Time Frame: 12 weeks ]Subjects will have optical coherence tomography done at baseline and 12 weeks; decrease in foveal thickness to < 300microns will be documented as resolution of clinically significant uveitic macular edema
- Resolution of Inflammation: Scleritis: 2 step decrease or down to grade 0 improvement of with photographic documentation [ Time Frame: 12 weeks ]Resolution of scleritis inflammation will be assessed by comparing baseline graded photographs compared to graded photographs at 12 weeks, utilizing the published standardized Sen grading scale for scleritis.
- Resolution of Inflammation: Resolution of retinal and choroidal infiltrate with photographic documentation [ Time Frame: 12 weeks ]Subjects will have photos at baseline and 12 weeks if they have posterior uveitis; the resolution of retinal and choroidal lesions will be documented by photographs
- Change in visual acuity [ Time Frame: 12 and 24 weeks ]The visual acuity of subjects will be measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart. The ETDRS scores will be converted to a logarithmic scale, LogMar units, which will be utilized to calculate mean and median change in visual acuity score from baseline to 12 and 24 weeks
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02764697
|United States, Florida|
|Tampa Bay Uveitis Center|
|St Petersburg, Florida, United States, 33709|
|Principal Investigator:||Grace L Clarke||Tampa Bay Uveitis Center, LLC|