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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5
Acthar gel for subcutaneous injection 80 units per mL (40 units per 0.5 mL)
Blue Ocean Clinical Research
Clearwater, Florida, United States
Midwest Eye Institute
Indianapolis, Indiana, United States
Massachusetts Eye Research and Surgery Institution (MERSI)
Waltham, Massachusetts, United States
Metropolitan Eye Research and Surgery Institute
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.
Time frame: 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.
Time frame: 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.
Time frame: Week 36
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.
Time frame: Week 36
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Palisades Park, New Jersey, 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
Virginia Eye Consultants
Norfolk, Virginia, United States