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

• ClinicalTrials.gov Identifier: NCT03656692
• Recruitment Status: Terminated
• First Posted: September 4, 2018
• Results First Posted: August 3, 2021
• Last Update Posted: August 3, 2021
• Sponsor: Mallinckrodt
• Information provided by (Responsible Party): Mallinckrodt

Study Description

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Locations

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

• Study Director: Clinical Team Lead; Mallinckrodt

  Study Documents (Full-Text)

Documents provided by Mallinckrodt:

Study Protocol and Statistical Analysis Plan  [PDF] September 18, 2019

More Information

• Responsible Party: Mallinckrodt
• ClinicalTrials.gov Identifier: NCT03656692
• Other Study ID Numbers: MNK61074105
• First Posted: September 4, 2018
• 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.

• 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:

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