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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03473964
Recruitment Status : Unknown
Verified March 2018 by John Huang, MD, New England Retina Associates.
Recruitment status was:  Not yet recruiting
First Posted : March 22, 2018
Last Update Posted : March 22, 2018
Sponsor:
Information provided by (Responsible Party):
John Huang, MD, New England Retina Associates

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones Sarcoidosis

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




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).



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03473964


Contacts
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Contact: John J Huang, MD 203-288-2020 jjqhuang@yahoo.com
Contact: Leslie D Hurst, MS 203-288-2020 lhurst@retinamd.com

Locations
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United States, Connecticut
New England Retina Associates
Hamden, Connecticut, United States, 06518
Sponsors and Collaborators
John Huang, MD
Investigators
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Principal Investigator: John J Huang, MD New England Retina Associates
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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    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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