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

NCT03656692 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: MNK61074105
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 8

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.

Conditions

Uveitis, Posterior; Uveitis, Intermediate; Panuveitis

Outcome Measures

Primary Outcomes (3)

• Score on the Nussenblatt Grading Scale

  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.

  Week 36

• Score on the Laser Flare Scale

  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.

  Week 36

• Score on the Aqueous Cell Scale

  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.

  Week 36

Secondary Outcomes (1)

• Diurnal Intraocular Pressure (IOP)

  Week 36

Study Arms (1)

Acthar Gel

OTHER

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

Interventions

Acthar Gel DRUG

Acthar gel for subcutaneous injection 80 units per mL (40 units per 0.5 mL)

Also known as: Corticotropin

Acthar Gel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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):
• Has active, inflammatory, chorioretinal and/or inflammatory retinal vascular lesion
• Has ≥ 2+ anterior chamber cells \[Standardization of Uveitis Nomenclature (SUN) criteria\]
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mallinckrodt: lead

Study Sites (8)

Blue Ocean Clinical Research

Clearwater, Florida, 33761, United States

Location

Midwest Eye Institute

Indianapolis, Indiana, 46290, United States

Location

Massachusetts Eye Research and Surgery Institution (MERSI)

Waltham, Massachusetts, 02451, United States

Location

Metropolitan Eye Research and Surgery Institute

Palisades Park, New Jersey, 07650, United States

Location

Bergstrom Eye Research, LLC

Fargo, North Dakota, 58103, United States

Location

Valley Retina Institute, PA

McAllen, Texas, 78503, United States

Location

Foresight Studies, LLC

San Antonio, Texas, 78240, United States

Location

Virginia Eye Consultants

Norfolk, Virginia, 23502, United States

Location

MeSH Terms

Conditions

Uveitis, Posterior; Uveitis, Intermediate; Panuveitis

Interventions

Adrenocorticotropic Hormone

Condition Hierarchy (Ancestors)

Uveitis; Uveal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Melanocortins; Pro-Opiomelanocortin; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormones, Anterior; Pituitary Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Results Point of Contact

• Title: Medical Information Call Center
• Organization: Mallinckrodt

medinfo@mnk.com

800-844-2830

Study Officials

• Clinical Team Lead

  Mallinckrodt

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2018
• First Posted: September 4, 2018
• Study Start: October 5, 2018
• Primary Completion: July 14, 2020
• Study Completion: July 14, 2020
• Last Updated: August 3, 2021
• Results First Posted: August 3, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)