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Ocular Sarcoidosis Open Label Trial of ACTHAR Gel

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ClinicalTrials.gov Identifier: NCT02725177
Recruitment Status : Recruiting
First Posted : March 31, 2016
Last Update Posted : February 12, 2018
Sponsor:
Collaborator:
Mallinckrodt
Information provided by (Responsible Party):
The Cleveland Clinic

Brief Summary:
Treatment with ACTHAR Gel will result in a reduction of ocular inflammation in patients with active ocular sarcoidosis that requires systemic immunosuppressant therapy (hypothesis)

Condition or disease Intervention/treatment Phase
Ocular Sarcoidosis Panuveitis Anterior Uveitis Drug: Repository Corticotropin Injection Drug: Repository Corticotropin Injection -Treatment Extension Not Applicable

Detailed Description:

The initial treatment of ocular sarcoidosis usually relies on a combination of topical glucocorticoids and oral glucocorticoids, both of which are associated with significant ocular and systemic toxicities. Steroid-sparing therapies are limited by variable and unpredictable efficacy, prolonged time until clinical response, medication intolerance, and difficulties obtaining payor approval. As a result, it is not uncommon that treating physicians must choose between excessive glucocorticoid toxicity versus poor control of ocular inflammation. Ongoing ocular inflammation, in turn, leads to eventual visual loss and occasionally blindness.

There is a need for a more reliable, expeditious therapy that can be used as an alternative to glucocorticoids in sarcoidosis uveitis. Adrenocorticotropic hormone, through activation of melanocortin receptors on leukocytes, can dampen immune responses through non-glucocorticoid dependent mechanisms. The proposed study will aim to define whether there is effectiveness for ACTHAR gel in these patients, delineate an effect dosing regimen, and provide information about the safety of this approach for moderate to severe ocular sarcoidosis.

ACTHAR is a 39-amino acid peptide natural form of adrenocorticotropin hormone (ACTH) that was initially approved in 1952 by the FDA. It has since been approved for 19 indications including respiratory sarcoidosis, multiple sclerosis, and infantile spasms.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ocular Sarcoidosis Open Label Trial of ACTHAR Gel
Study Start Date : March 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sarcoidosis

Arm Intervention/treatment
Experimental: H.P. Achtar Gel 80 U
H.P. Acthar Gel (repository corticotropin) Injection, 80 U daily for 10 days, then 80 U twice weekly for up to a total of 24 weeks on therapy.
Drug: Repository Corticotropin Injection

Treatment with ACTHAR Gel for 24 weeks

  • Initial treatment with 80 units daily for ten days (induction phase)
  • Maintenance treatment with 80 units twice weekly (maintenance phase)
Other Names:
  • H.P. Acthar Gel
  • ACTH Gel
  • ACTH

Drug: Repository Corticotropin Injection -Treatment Extension
24 open label extension permitted in subjects who respond to treatment
Other Names:
  • H.P. Acthar Gel
  • ACTH Gel
  • ACTH




Primary Outcome Measures :
  1. Proportion of patients with clinically significant improvement in visual acuity [ Time Frame: Measured at 24 weeks ]

Secondary Outcome Measures :
  1. Proportion of patients with clinically significant improvement in the resolution-intraocular inflammation [ Time Frame: Measured at 24 weeks ]
  2. Proportion of patients experiencing a tapering of ocular/oral steroids by at least 50% [ Time Frame: Measured at 24 weeks ]
  3. Proportion of patients with a clinically significant reduction-cystoid macular edema [ Time Frame: Measured at 24 weeks ]


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient with sarcoidosis as defined by ATS/ERS/WASOG guidelines (American Thoracic Society/European Respiratory Society /World Association of Sarcoidosis and Other Granulomatous Diseases)
  • Any posterior, intermediate or panuveitis of sufficient severity to warrant therapy, in the opinion of the treating physician --OR-- Anterior uveitis requiring 4 or more daily applications of topical corticosteroids to maintain control of inflammation, or uncontrolled with topical therapy
  • Persistent disease activity (active uveitis) at the time of screening

Exclusion Criteria:

  • Other cause for ocular inflammation
  • Uncontrolled diabetes, hypertension, or other contra-indication to increased dosage of glucocorticoids
  • Recent (less than 4 weeks) intra-ocular or intra-orbital steroid injection
  • Escalation of immunosuppressive medications between screening and initiation of the study medication
  • Severe extra-ocular sarcoidosis likely to require additional therapy (in the opinion of the investigator)
  • Administration of an investigational medication for sarcoidosis within 3 months, or 5 half-lives, whichever is longer
  • Have a history of any opportunistic infection within 6 months prior to screening
  • Have any history of malignancy, except fully resected cutaneous squamous cell cancer or cutaneous basal cell cancer, or cervical carcinoma in-situ with a minimum of 5 years period without recurrence
  • Severe other organ disease felt to be likely to lead to death within the next six months
  • Unable to follow the study protocol, including the requisite travel and follow-up ocular testing
  • Women of childbearing potential must be using adequate birth control measures (abstinence, hormonal contraceptives, intrauterine device, barrier method with spermicide, or surgical sterilization) and must agree to continue such precautions, and not become pregnant or plan a pregnancy for 6 months after receiving their last treatment with study agent. Women of childbearing potential must test negative on a serum pregnancy test at screening.
  • Breastfeeding women are excluded from participation

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): NCT02725177


Contacts
Contact: Daniel A Culver, DO 216-444-6508 culverd@ccf.org

Locations
United States, Ohio
Cleveland Clinical Foundation Recruiting
Cleveland, Ohio, United States, 44145
Sponsors and Collaborators
The Cleveland Clinic
Mallinckrodt
Investigators
Principal Investigator: Daniel A Culver, DO The Cleveland Clinic

Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT02725177     History of Changes
Other Study ID Numbers: Ocular Sarcoidosis 15-1072
First Posted: March 31, 2016    Key Record Dates
Last Update Posted: February 12, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by The Cleveland Clinic:
Ocular Sarcoidosis

Additional relevant MeSH terms:
Uveitis
Sarcoidosis
Uveitis, Anterior
Iridocyclitis
Panuveitis
Uveal Diseases
Eye Diseases
Lymphoproliferative Disorders
Lymphatic Diseases
Iris Diseases
Adrenocorticotropic Hormone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs