(ACTH) for the Treatment of Sarcoid Uveitis

Study Overview
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Brief Summary
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Sarcoidosis is a multisystem granulomatous disease that can affect nearly any organ in the body. While most commonly affecting the lungs, vision threatening eye involvement occurs in approximately 25% of patients with sarcoid. Eye involvement may lead to a chronic, sight-threatening uveitis which may result in cataract, glaucoma, and macular edema. The treatment of sarcoid uveitis involves the use of topical and systemic corticosteroids or potent immunosuppressive agents (medications that suppress the body's immune system) both of which can cause severe long-term side effects. The adverse effects of steroids may be avoided by treatment with the use as H.P. Acthar® Gel. The effectiveness of H.P. Acthar® Gel in the treatment of sarcoid uveitis and patient quality of live have not been previously examined. These issues, will be explored in this research.

Detailed Description
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The Investigator seeks to determine the efficacy of H.P. Acthar® Gel (40 units twice weekly injection) of on disease activity and severity in patients with sarcoid uveitis. The retrospective study will evaluate a series of quantitative outcome measures: The degree of aqueous and vitreous inflammatory cells as graded by the criteria established by the Standardization of Uveitis Nomenclature (SUN) criteria at intervals of 0 weeks, 3 weeks, 6 weeks, 12 weeks and 24 weeks. The degree of aqueous flare as graded by the criteria established by the Standardization of Uveitis Nomenclature (SUN) criteria at intervals of 0 weeks, 4 weeks,12 weeks and 24 weeks. Best Corrected Visual Acuity at intervals of 0 weeks, 4 weeks, 12 weeks and 24 weeks. Central Macular Thickness at intervals of 0 weeks, 4 weeks, 12 weeks and 24 weeks as measured by Optical Coherence Tomography (OCT). Intraocular pressure at intervals of 0 weeks, 4 weeks, 12 weeks and 24 weeks as measured by applanation tonometry Quality of life assessment using National Eye Institute Visual Function Questionnaire (VFQ-25) The Investigator expects to retrospectively review the charts of 10 sarcoid associated uveitis patients treated with Acthar® Gel over a period of 1 year.

Official Title
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Adrenocorticotrophic Hormone (ACTH) for the Treatment of Sarcoid Uveitis

Conditions
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Sarcoid Uveitis

Intervention / Treatment
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* Drug: H.P. Acthar gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Presence of Sarcoid Uveitis as determined by clinical exam fluorescence angiography optical coherence tomography Exclusion Criteria: Presence of long acting intraocular depots Women of childbearing age not using contraceptives
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Treatment<br>The study intervention is the observation of study subjects who have received H.P. Acthar® Gel (adrenocorticotrophic hormone), 40 units twice weekly injections in patients who have sarcoid uveitis and to assess it's effectiveness by measuring changes the degree of aqueous and vitreous inflammatory cells present, the degree of aqueous flare, and changes in visual acuity, macular thickness, intraocular pressure and quality of life measures assessed by using the National Eye Institute Visual Function Questionnaires (VFQ-25) | Drug: H.P. Acthar gel<br>* H.P. Acthar gel: Injection 40 mg twice weekly<br>* Other names: adrenocorticotrophic hormone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of aqueous and vitreous inflammatory cells-change is being assessed | Degree of aqueous and vitreous inflammatory cells as graded by the criteria established by the Standardization of Uveitis Nomenclature (SUN) | 0 weeks, 4 weeks, 12 weeks and 24 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of aqueous flare- change is being assessed | Degree of aqueous flare as graded by the criteria established by Standardization of Uveitis Nomenclature (SUN) | 0 weeks, 4 weeks 12 weeks and 24 weeks | 
| Visual acuity- change is being assessed | Testing and evaluation of best corrected visual acuity using Luxvision trial frames and Precision Vision ETDRS charts R,1 and 2 | 0 weeks, 4 weeks, 12 weeks and 24 weeks | 
| Central macular thickness- change is being assessed | Central macular thickness as measured by Spectralis Optical Coherence Tomography (OCT) | 0 weeks, 4 weeks, 12 weeks and 24 weeks | 
| Intraocular pressure | Intraocular pressure as measured by applanation tonometry | 0 weeks, 4 weeks, 12 weeks and 24 weeks | 
| Quality of life assessment- change is being assessed | Quality of life assessment using the National Eye Institute Visual Function Questionnaire (VFQ-25). The VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single item general health rating question. The scoring ranges in scores from 1-6, 1 being activity presents no difficulty and 6 being can no longer perform this activity due to vision. The VFQ-25 generates the following vision-targeted subscales : global vision rating (1), difficulty with near vision activities (3), difficulty with distance vision activities (3), limitations in social functioning due to vision (2), role limitations due to vision(2), dependency on others due to vision (3), mental health symptoms due to vision (4), driving difficulties (3), limitations with peripheral (1) and color vision (I), and ocular pain (2). | 0 weeks, 4 weeks, 12 weeks and 24 weeks |