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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03656692
Other study ID # MNK61074105
Secondary ID
Status Terminated
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


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
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