Ignite Creation Date:
2024-05-06 @ 11:15 AM
Last Modification Date:
2024-10-26 @ 12:42 PM
Study NCT ID:
NCT03473964
Status:
UNKNOWN
Last Update Posted:
2018-03-22
First Post:
2018-01-31
Brief Title:
ACTH for the Treatment of Sarcoid Uveitis
Sponsor:
John Huang MD
Organization:
New England Retina Associates
Study Overview
Official Title:
Adrenocorticotrophic Hormone ACTH for the Treatment of Sarcoid Uveitis
Status:
UNKNOWN
Status Verified Date:
2018-03
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ACTH
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 bodys 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 HP Acthar Gel The effectiveness of HP 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 HP 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 weeks12 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
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 weeks12 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None