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

Uveitis, Posterior Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03656692
• Other study ID #: MNK61074105
• Status: Terminated
• Phase: Phase 4
• Start date: October 5, 2018
• Est. completion date: July 14, 2020

Study information

• Verified date: July 2021
• Source: Mallinckrodt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: July 14, 2020
• Est. primary completion date: July 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Panuveitis
• Uveitis
• Uveitis, Intermediate
• Uveitis, Posterior

Intervention

Drug:
• Acthar Gel
Acthar gel for subcutaneous injection 80 units per mL (40 units per 0.5 mL)

Locations

Country	Name	City	State
United States	Blue Ocean Clinical Research	Clearwater	Florida
United States	Bergstrom Eye Research, LLC	Fargo	North Dakota
United States	Midwest Eye Institute	Indianapolis	Indiana
United States	Valley Retina Institute, PA	McAllen	Texas
United States	Virginia Eye Consultants	Norfolk	Virginia
United States	Metropolitan Eye Research and Surgery Institute	Palisades Park	New Jersey
United States	Foresight Studies, LLC	San Antonio	Texas
United States	Massachusetts Eye Research and Surgery Institution (MERSI)	Waltham	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Mallinckrodt

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Diurnal Intraocular Pressure (IOP)	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.	Week 36