(ACTH) for the Treatment of Sarcoid Uveitis
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/17/2018 |
| Start Date: | April 1, 2018 |
| End Date: | January 2020 |
| Contact: | John J Huang, MD |
| Email: | jjqhuang@yahoo.com |
| Phone: | 203-288-2020 |
Adrenocorticotrophic Hormone (ACTH) for the Treatment of Sarcoid Uveitis
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.
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.
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.
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.
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
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