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

• ClinicalTrials.gov Identifier: NCT03473964
• Recruitment Status: Unknown
• First Posted: March 22, 2018
• Last Update Posted: March 22, 2018
• Sponsor: John Huang, MD
• Information provided by (Responsible Party): John Huang, MD, New England Retina Associates

Study Description

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.

Condition or disease	Intervention/treatment
Sarcoid Uveitis	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 Design

• Study Type: Observational
• Estimated Enrollment: 10 participants
• Observational Model: Case-Only
• Time Perspective: Retrospective
• Official Title: Adrenocorticotrophic Hormone (ACTH) for the Treatment of Sarcoid Uveitis
• Estimated Study Start Date: April 1, 2018
• Estimated Primary Completion Date: March 2019
• Estimated Study Completion Date: January 2020

Groups and Cohorts

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 Name: adrenocorticotrophic hormone

Outcome Measures

Primary Outcome Measures :

1. Degree of aqueous and vitreous inflammatory cells-change is being assessed [ Time Frame: 0 weeks, 4 weeks, 12 weeks and 24 weeks. ]
   Degree of aqueous and vitreous inflammatory cells as graded by the criteria established by the Standardization of Uveitis Nomenclature (SUN)

Secondary Outcome Measures :

1. Degree of aqueous flare- change is being assessed [ Time Frame: 0 weeks, 4 weeks 12 weeks and 24 weeks ]
   Degree of aqueous flare as graded by the criteria established by Standardization of Uveitis Nomenclature (SUN)
2. Visual acuity- change is being assessed [ Time Frame: 0 weeks, 4 weeks, 12 weeks and 24 weeks ]
   Testing and evaluation of best corrected visual acuity using Luxvision trial frames and Precision Vision ETDRS charts R,1 and 2
3. Central macular thickness- change is being assessed [ Time Frame: 0 weeks, 4 weeks, 12 weeks and 24 weeks ]
   Central macular thickness as measured by Spectralis Optical Coherence Tomography (OCT)
4. Intraocular pressure [ Time Frame: 0 weeks, 4 weeks, 12 weeks and 24 weeks ]
   Intraocular pressure as measured by applanation tonometry
5. Quality of life assessment- change is being assessed [ Time Frame: 0 weeks, 4 weeks, 12 weeks and 24 weeks ]
   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).

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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.

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

Contacts and Locations

Contacts

Contact: John J Huang, MD; 203-288-2020; jjqhuang@yahoo.com

Contact: Leslie D Hurst, MS; 203-288-2020; lhurst@retinamd.com

Locations

United States, Connecticut

New England Retina Associates

Hamden, Connecticut, United States, 06518

Sponsors and Collaborators

John Huang, MD

Investigators

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

More Information

• Responsible Party: John Huang, MD, MD ophthalmologist, New England Retina Associates
• ClinicalTrials.gov Identifier: NCT03473964
• Other Study ID Numbers: 1169914
• First Posted: March 22, 2018
• Last Update Posted: March 22, 2018
• Last Verified: March 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• 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

Additional relevant MeSH terms:

Uveitis; Sarcoidosis; Uveal Diseases; Eye Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Adrenocorticotropic Hormone; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs