(ACTH) for the Treatment of Sarcoid Uveitis

NCT ID: NCT03473964

Last Updated: 2018-03-22

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-04-01
• Study Completion Date: 2020-01-31

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.

Conditions

Sarcoid Uveitis

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Study Groups

Treatment

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)

H.P. Acthar gel

Intervention Type: DRUG

H.P. Acthar gel:

Injection 40 mg twice weekly

Interventions

H.P. Acthar gel

H.P. Acthar gel:

Injection 40 mg twice weekly

Intervention Type: DRUG

Other Intervention Names

adrenocorticotrophic hormone

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

John Huang, MD

OTHER

Sponsor Role: lead

Responsible Party

John Huang, MD

MD ophthalmologist

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

John J Huang, MD

Role: PRINCIPAL_INVESTIGATOR

New England Retina Associates

Locations

New England Retina Associates

Hamden, Connecticut, United States

Countries

United States

Central Contacts

John J Huang, MD

Role: CONTACT

jjqhuang@yahoo.com

203-288-2020

Leslie D Hurst, MS

Role: CONTACT

lhurst@retinamd.com

203-288-2020

Other Identifiers

1169914

Identifier Type: -

Identifier Source: org_study_id