(ACTH) for the Treatment of Sarcoid Uveitis

Sarcoid Uveitis Clinical Trial

— ACTH  

Official title:

Adrenocorticotrophic Hormone (ACTH) for the Treatment of Sarcoid Uveitis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03473964
• Other study ID #: 1169914
• Status: Not yet recruiting
• First received: January 31, 2018
• Last updated: March 15, 2018
• Start date: April 1, 2018
• Est. completion date: January 2020

Study information

• Verified date: March 2018
• Source: New England Retina Associates
• Contact: John J Huang, MD
• Phone: 203-288-2020
• Email: jjqhuang[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: January 2020
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Sarcoid Uveitis
• Sarcoidosis
• Uveitis

Intervention

Drug:
• H.P. Acthar gel
H.P. Acthar gel: Injection 40 mg twice weekly

Locations

Country	Name	City	State
United States	New England Retina Associates	Hamden	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
John Huang, MD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Intraocular pressure	Intraocular pressure as measured by applanation tonometry	0 weeks, 4 weeks, 12 weeks and 24 weeks
Secondary	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