Clinical trial NCT03473964: (ACTH) for the Treatment of Sarcoid Uveitis
Official title: Adrenocorticotrophic Hormone (ACTH) for the Treatment of Sarcoid Uveitis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sarcoid Uveitis
Lead sponsor: New England Retina Associates
Sponsor class: OTHER
First posted: 2018-03-22
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patient with sarcoid uveitis with disease activity, as determined by clinical exam, fluorescein angiography and optical coherence tomography.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Degree of aqueous and vitreous inflammatory cells-change is being assessed
timeFrame: 0 weeks, 4 weeks, 12 weeks and 24 weeks.
Secondary outcomes:
measure: Degree of aqueous flare- change is being assessed
timeFrame: 0 weeks, 4 weeks 12 weeks and 24 weeks
measure: Visual acuity- change is being assessed
timeFrame: 0 weeks, 4 weeks, 12 weeks and 24 weeks
measure: Central macular thickness- change is being assessed
timeFrame: 0 weeks, 4 weeks, 12 weeks and 24 weeks
measure: Intraocular pressure
timeFrame: 0 weeks, 4 weeks, 12 weeks and 24 weeks
measure: Quality of life assessment- change is being assessed
timeFrame: 0 weeks, 4 weeks, 12 weeks and 24 weeks
Other outcomes:
Locations:
city: Hamden
country: United States
facility: New England Retina Associates
state: Connecticut
Study officials:
affiliation: New England Retina Associates
name: John J Huang, MD
role: PRINCIPAL_INVESTIGATOR
References: