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

Phase 4

Terminated

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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Acthar Gel	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.

Primary Outcome Measures

Name	Time	Method
Score on the Nussenblatt Grading Scale	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.
Score on the Laser Flare Scale	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.
Score on the Aqueous Cell Scale	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

Name	Time	Method
Diurnal Intraocular Pressure (IOP)	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.

Locations (8): Blue Ocean Clinical Research
🇺🇸
Clearwater, Florida, United States
Bergstrom Eye Research, LLC
🇺🇸
Fargo, North Dakota, United States
Valley Retina Institute, PA
🇺🇸
McAllen, Texas, United States
Foresight Studies, LLC
🇺🇸
San Antonio, Texas, United States
Midwest Eye Institute
🇺🇸
Indianapolis, Indiana, United States
Massachusetts Eye Research and Surgery Institution (MERSI)
🇺🇸
Waltham, Massachusetts, United States
Virginia Eye Consultants
🇺🇸
Norfolk, Virginia, United States
Metropolitan Eye Research and Surgery Institute
🇺🇸
Palisades Park, New Jersey, United States