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Safety and Effectiveness of Acthar Gel for Inflammation of the Eye's Uvea (Middle Layer)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03656692
Recruitment Status : Recruiting
First Posted : September 4, 2018
Last Update Posted : February 25, 2020
Sponsor:
Information provided by (Responsible Party):
Mallinckrodt

Brief Summary:

The main reason for this study is to see if Acthar Gel can reduce inflammation in the uvea.

Also, safety information when using it for this purpose will be collected.


Condition or disease Intervention/treatment Phase
Uveitis, Posterior Uveitis, Intermediate Panuveitis Drug: Acthar Gel Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Open Label Pilot Study to Explore the Efficacy and Safety of Acthar Gel in Subjects With Severe Noninfectious Intermediate Uveitis, Posterior Uveitis, or Panuveitis (NIPPU)
Actual Study Start Date : October 5, 2018
Estimated Primary Completion Date : July 16, 2022
Estimated Study Completion Date : July 16, 2022


Arm Intervention/treatment
Acthar Gel
Participants receive Acthar Gel as follows: 1 mL 2x/week for 36 weeks, followed by a taper to 1 mL/week for two weeks, and then 0.5 mL/week for an additional 2 weeks
Drug: Acthar Gel
Acthar gel for subcutaneous injection 80 units per mL (40 units per 0.5 mL)
Other Name: Corticotropin




Primary Outcome Measures :
  1. Score on the Nussemblatt Grading Scale [ Time Frame: Week 36 ]
    The Nussemblatt grading scale uses photographic measurement of cloudy, declining vision (vitreous haze). The scale goes from 0 to 4, and lower scores are better.

  2. Score on the Laser Flare Scale [ Time Frame: Week 36 ]
    Protein that escapes from blood vessels inside the eye make a sudden burst of scattered light (flare) when a laser shines on them. This is called a laser flare. It is used to measure the amount and size of proteins in the clear fluid in the front of the eyeball (aqueous humour). The larger the flare, the more inflammation is inside the eye (intraocular inflammation) in patients with uveitis. Laser flare is scored on a scale from 0 (no visible flare when compared with the normal eye) to 3 (severe - very dense flare). Lower scores are better.

  3. Score on the Aqueous Cell Scale [ Time Frame: Week 36 ]
    The number of cells (like white blood cells) floating in the aqueous humour (aqueous cells) are measured on a scale from 0 (none) to 4 (more than 30 cells), and lower scores are better.


Secondary Outcome Measures :
  1. Number of participants with an adverse event [ Time Frame: Week 36 ]
    Clinically significant changes in clinical and ocular measurements are considered adverse events.

  2. Diurnal Intraocular Pressure (IOP) [ Time Frame: Week 36 ]
    Eye pressure is measured in millimeters of mercury (mmHg). Normal eye pressure ranges from 12-22 mmHg, and eye pressure greater than 22 mmHg is considered higher than normal. During a 24-hour period, IOP normally varies by 2 to 6 mmHg because of different amounts of secretion and drainage at different times of the day. The word diurnal means "around the day," and IOP means "pressure inside the eye", so diurnal IOP is the measure of pressure inside the eye during a 24-hour period. Diurnal IOP is measured in millimeters of mercury (mmHg) using Goldmann Applanation Tonometry (GAT). Lower scores are better.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • Has been informed, understands the nature and risks of the study, and signed and dated the informed consent form
  • Has diagnosis of current severe NIPPU and active disease at the Baseline Visit as defined by the presence of at least 1 of the following parameters in at least one eye despite at least 2 weeks of current or prior history of maintenance therapy with oral prednisone (or oral corticosteroid equivalent):

    1. Active, inflammatory, chorioretinal and/or inflammatory retinal vascular lesion
    2. At least 2+ anterior chamber cells [Standardization of Uveitis Nomenclature (SUN) criteria]
    3. At least 1.5+ vitreous haze measurements (Nussenblatt et al, 1985)
  • If on concomitant immunosuppressive therapy at screening, has not had a dose increase in the 2 weeks prior to screening
  • If currently taking corticosteroids, is willing to taper current doses of corticosteroid and immunomodulatory therapy to the minimum effective dose during the study
  • If has solid tumor malignancy, but is not currently, and has not received therapy for it during the 3 years prior to Screening Visit might be eligible, after consulting with personal oncologist
  • If has treated and cured basal cell carcinoma, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix might also be eligible
  • If has a comorbid condition and is being treated with immunosuppressants and/or immunomodulators, has been at a stable dose at least 2 weeks prior to screening
  • Is of nonchildbearing potential or is nonpregnant, nonlactating and agrees to use protocol-defined effective contraception throughout study participation until the Follow-up Visit
  • Has a mean systolic blood pressure ≤ 150 mm Hg and a diastolic blood pressure of ≤ 90 mm Hg determined by the average of 3 seated readings taken at least 5 minutes apart at the Screening and Baseline Visits

Exclusion Criteria:

  • Is from a vulnerable population (per 45CFR46 and/or other local and national regulations), including but not limited to:

    1. Employees (temporary, part-time, full time, etc)
    2. A family member of the research staff conducting the study, or of the sponsor, of the clinical research organization, or of the ethics committee (IRB/IEC)
  • Has history of sensitivity to ACTH preparations or sensitivity to porcine protein products
  • Has had (within the previous 6 months) diabetic retinopathy, age-related macular degeneration, intraocular surgery, ocular trauma, cataracts, or posterior capsule opacification
  • Had a glucocorticosteroid implant (such as Retisert®, Iluvien®, or Yutiq™) within 3 years prior to the Baseline Visit, complications related to the device, had one removed within 90 days prior to the Baseline Visit, and/or had complications related to removal of the device
  • Received intraocular or periocular corticosteroids within 30 days prior to Baseline Visit
  • Has proliferative or severe nonproliferative diabetic retinopathy or clinically significant macular edema due to diabetic retinopathy
  • Has neovascular/wet age-related macular degeneration
  • Has an abnormality of a vitreoretinal interface (ie, vitreomacular traction, epiretinal membranes, etc) with the potential for macular structural damage independent of the inflammatory process
  • Has a severe vitreous haze that precludes visualization of the fundus at the Baseline Visit
  • Has any known contraindication(s) to Acthar Gel including, but not limited to: known history of scleroderma, osteoporosis, or ocular herpes simplex. For the purposes of this trial, osteoporosis is defined as evidence of current vertebral or long bone fracture, or a bone density lumbar T-score > 2.0 standard deviations (SD) below the mean of the reference population
  • Has primary adrenocortical insufficiency, or adrenal cortical hyperfunction
  • Has current congestive heart failure (as defined by New York Heart Association)
  • Has history of chronic active hepatitis including active or chronic hepatitis B, or acute or chronic hepatitis C
  • Has history of tuberculosis (TB) infection, close contact with an individual with an active TB infection, or signs/symptoms of TB or a positive or indeterminate interferon gamma release assay (IGRA) for TB at screening
  • Has known immune compromised status (not related to disease/condition under study), including, but not limited to individuals who have undergone organ transplantation or who are known to be positive for the human immunodeficiency virus
  • Has any of the protocol-defined laboratory abnormalities at the Screening Visit
  • Has other clinically significant disease, disorder or laboratory abnormality (even if included on the package insert) which the investigator thinks might put the patient at risk, make them unable to complete the study, or influence the study results

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): NCT03656692


Contacts
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Contact: For information about participating 800-556-3314 ext 5 clinicaltrials@mnk.com

Locations
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United States, Arizona
Retinal Research Institute, LLC Withdrawn
Phoenix, Arizona, United States, 85014
Retina Center PC Withdrawn
Tucson, Arizona, United States, 85704
United States, Florida
Blue Ocean Clinical Research Recruiting
Clearwater, Florida, United States, 33761
United States, Illinois
University Retina and Macula Associates PC Withdrawn
Lemont, Illinois, United States, 60439
United States, Indiana
Midwest Eye Institute Recruiting
Indianapolis, Indiana, United States, 46290
United States, Massachusetts
Massachusetts Eye Research and Surgery Institution (MERSI) Recruiting
Waltham, Massachusetts, United States, 02451
United States, New Jersey
Metropolitan Eye Research and Surgery Institute Recruiting
Palisades Park, New Jersey, United States, 07650
Metropolitan Eye Research and Surgery Institute Withdrawn
Teaneck, New Jersey, United States, 07666
United States, North Dakota
Bergstrom Eye Research, LLC Recruiting
Fargo, North Dakota, United States, 58103
United States, Texas
Austin Retina Associates Withdrawn
Austin, Texas, United States, 78705
Valley Retina Institute, PA Recruiting
McAllen, Texas, United States, 78503
Foresight Studies, LLC Recruiting
San Antonio, Texas, United States, 78240
United States, Virginia
Virginia Eye Consultants Recruiting
Norfolk, Virginia, United States, 23502
Sponsors and Collaborators
Mallinckrodt
Investigators
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Study Director: Clinical Team Lead Mallinckrodt

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Responsible Party: Mallinckrodt
ClinicalTrials.gov Identifier: NCT03656692    
Other Study ID Numbers: MNK61074105
First Posted: September 4, 2018    Key Record Dates
Last Update Posted: February 25, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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.: Yes
Additional relevant MeSH terms:
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Uveitis
Uveitis, Posterior
Uveitis, Intermediate
Adrenocorticotropic Hormone
Panuveitis
Pars Planitis
Uveal Diseases
Eye Diseases
Choroiditis
Choroid Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs