(ACTH) for the Treatment of Sarcoid Uveitis

• Conditions: Sarcoid Uveitis
• Interventions: Drug: H.P. Acthar gel

• Registration Number: NCT03473964
• Lead Sponsor: John Huang, MD

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2018-01-31
• Status Verified: 2018-03
• Study First Submitted QC: 2018-03-15
• Last Update Submitted: 2018-03-15
• Study First Posted: 2018-03-22
• Last Update Posted: 2018-03-22
• Study Start: 2018-04-01
• Primary Completion: 2019-03
• Study Completion: 2020-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Presence of Sarcoid Uveitis as determined by

• clinical exam
• fluorescence angiography
• optical coherence tomography

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Exclusion Criteria

• Presence of long acting intraocular depots
• Women of childbearing age not using contraceptives

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Treatment	H.P. Acthar gel	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)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Intraocular pressure	0 weeks, 4 weeks, 12 weeks and 24 weeks	Intraocular pressure as measured by applanation tonometry
Degree of aqueous flare- change is being assessed	0 weeks, 4 weeks 12 weeks and 24 weeks	Degree of aqueous flare as graded by the criteria established by Standardization of Uveitis Nomenclature (SUN)
Central macular thickness- change is being assessed	0 weeks, 4 weeks, 12 weeks and 24 weeks	Central macular thickness as measured by Spectralis Optical Coherence Tomography (OCT)
Quality of life assessment- change is being assessed	0 weeks, 4 weeks, 12 weeks and 24 weeks	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).
Visual acuity- change is being assessed	0 weeks, 4 weeks, 12 weeks and 24 weeks	Testing and evaluation of best corrected visual acuity using Luxvision trial frames and Precision Vision ETDRS charts R,1 and 2

Trial Locations

Locations (1)

New England Retina Associates; 🇺🇸 Hamden, Connecticut, United States