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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03656692
Recruitment Status : Terminated (Logistical challenges; no safety concerns)
First Posted : September 4, 2018
Results First Posted : August 3, 2021
Last Update Posted : August 3, 2021
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)
Actual Enrollment : 5 participants
Allocation: N/A
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
Actual Primary Completion Date : July 14, 2020
Actual Study Completion Date : July 14, 2020


Arm Intervention/treatment
Acthar Gel
Participants received Acthar 1 mL (80 units [U]) subcutaneously (SC) 2 times per week for 36 weeks followed by a taper to Acthar 1 mL (80 U) SC once a week for 2 weeks, then 0.5 mL (40 U) SC once a week for 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 Nussenblatt Grading Scale [ Time Frame: Week 36 ]
    The Nussenblatt 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. 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

Inclusion criteria:

  • Is male or nonpregnant, nonlactating female
  • Has been diagnosed with current severe NIPPU
  • Has 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 maintenance therapy with oral prednisone (or oral corticosteroid equivalent):

    1. Has active, inflammatory, chorioretinal and/or inflammatory retinal vascular lesion
    2. Has ≥ 2+ anterior chamber cells [Standardization of Uveitis Nomenclature (SUN) criteria]
    3. Has ≥ 1.5+ vitreous haze
  • Is willing to taper current doses of corticosteroid and immunomodulatory therapy to the minimum effective dose during the study.
  • If under treatment with any immunosuppressants, immunomodulators, or biologic agents for a comorbid condition, has been on a stable dose for 2 weeks before screening

Exclusion criteria:

  • Has proliferative or severe nonproliferative diabetic retinopathy, clinically significant macular edema due to diabetic retinopathy, neovascular/wet age-related macular degeneration, abnormality of vitreoretinal interface with the potential for macular structural damage independent of the inflammatory process or severe vitreous haze that precludes visualization of the fundus at the Baseline Visit
  • Has Type 1 or Type 2 diabetes mellitus, tuberculosis, history of hepatitis, peptic ulcer, active infection, or any contraindication for treatment with Acthar Gel

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


Locations
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United States, Florida
Blue Ocean Clinical Research
Clearwater, Florida, United States, 33761
United States, Indiana
Midwest Eye Institute
Indianapolis, Indiana, United States, 46290
United States, Massachusetts
Massachusetts Eye Research and Surgery Institution (MERSI)
Waltham, Massachusetts, United States, 02451
United States, New Jersey
Metropolitan Eye Research and Surgery Institute
Palisades Park, New Jersey, United States, 07650
United States, North Dakota
Bergstrom Eye Research, LLC
Fargo, North Dakota, United States, 58103
United States, Texas
Valley Retina Institute, PA
McAllen, Texas, United States, 78503
Foresight Studies, LLC
San Antonio, Texas, United States, 78240
United States, Virginia
Virginia Eye Consultants
Norfolk, Virginia, United States, 23502
Sponsors and Collaborators
Mallinckrodt
Investigators
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Study Director: Clinical Team Lead Mallinckrodt
  Study Documents (Full-Text)

Documents provided by 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
Results First Posted: August 3, 2021
Last Update Posted: August 3, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Discussion of statistical endpoints and analysis are included in manuscripts. Summary aggregate (basic) results (including adverse events information) and the study protocol are made available on clinicaltrials.gov (NCT03656692) when required by regulation. Individual de-identified patient data will not be disclosed. Requests for additional information should be directed to the company at medinfo@mnk.com.

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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