(ACTH) for the Treatment of Sarcoid Uveitis

NCT03473964 | Unknown FDA Drug

• 1 other identifier: 1169914
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcoid Uveitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Degree of aqueous flare- change is being assessed

  0 weeks, 4 weeks 12 weeks and 24 weeks

• Visual acuity- change is being assessed

  0 weeks, 4 weeks, 12 weeks and 24 weeks

• Central macular thickness- change is being assessed

  0 weeks, 4 weeks, 12 weeks and 24 weeks

• Intraocular pressure

  0 weeks, 4 weeks, 12 weeks and 24 weeks

• Quality of life assessment- change is being assessed

  0 weeks, 4 weeks, 12 weeks and 24 weeks

Study Arms (1)

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

Interventions

H.P. Acthar gel DRUG

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

Also known as: adrenocorticotrophic hormone

Treatment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Presence of Sarcoid Uveitis as determined by
• clinical exam
• fluorescence angiography
• optical coherence tomography

You may not qualify if:

• Presence of long acting intraocular depots
• Women of childbearing age not using contraceptives

Sponsors & Collaborators

• John Huang, MD: lead

Study Sites (1)

New England Retina Associates

Hamden, Connecticut, 06518, United States

Location

MeSH Terms

Interventions

Adrenocorticotropic Hormone

Intervention Hierarchy (Ancestors)

Melanocortins; Pro-Opiomelanocortin; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormones, Anterior; Pituitary Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Officials

• John J Huang, MD

  New England Retina Associates

  PRINCIPAL INVESTIGATOR

Central Study Contacts

John J Huang, MD

CONTACT

203-288-2020; jjqhuang@yahoo.com

Leslie D Hurst, MS

CONTACT

203-288-2020; lhurst@retinamd.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD ophthalmologist

Study Record Dates

• First Submitted: January 31, 2018
• First Posted: March 22, 2018
• Study Start: April 1, 2018
• Primary Completion: March 1, 2019
• Study Completion: January 1, 2020
• Last Updated: March 22, 2018

Record last verified: 2018-03

Locations

US (1)