(ACTH) for the Treatment of Sarcoid Uveitis (ACTH)

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.

Study Overview

• Status: Unknown
• Conditions: Sarcoid Uveitis
• Intervention / Treatment: Drug: H.P. Acthar gel

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.

• Study Type: Observational
• Enrollment (Anticipated): 10

Contacts and Locations

• Study Contact: Name: John J Huang, MD; Phone Number: 203-288-2020; Email: jjqhuang@yahoo.com
• Study Contact Backup: Name: Leslie D Hurst, MS; Phone Number: 203-288-2020; Email: lhurst@retinamd.com

Study Locations

• United States
  • Connecticut
    • Hamden, Connecticut, United States, 06518
      • New England Retina Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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)

Drug: H.P. Acthar gel; H.P. Acthar gel: Injection 40 mg twice weekly; Other Names: adrenocorticotrophic hormone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Intraocular pressure	Intraocular pressure as measured by applanation tonometry	0 weeks, 4 weeks, 12 weeks and 24 weeks
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

Collaborators and Investigators

• Sponsor: John Huang, MD
• Investigators: Principal Investigator: John J Huang, MD, New England Retina Associates

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): April 1, 2018
• Primary Completion (ANTICIPATED): March 1, 2019
• Study Completion (ANTICIPATED): January 1, 2020

Study Registration Dates

• First Submitted: January 31, 2018
• First Submitted That Met QC Criteria: March 15, 2018
• First Posted (ACTUAL): March 22, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 22, 2018
• Last Update Submitted That Met QC Criteria: March 15, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lymphoproliferative Disorders; Lymphatic Diseases; Eye Diseases; Uveal Diseases; Uveitis; Sarcoidosis; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Adrenocorticotropic Hormone
• Other Study ID Numbers: 1169914

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No