Safety and Effectiveness of Acthar Gel for Inflammation of the Eye's Uvea (Middle Layer)
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|ClinicalTrials.gov Identifier: NCT03656692|
Recruitment Status : Terminated (Logistical challenges; no safety concerns)
First Posted : September 4, 2018
Results First Posted : August 3, 2021
Last Update Posted : August 3, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Uveitis, Posterior Uveitis, Intermediate Panuveitis||Drug: Acthar Gel||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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)|
|Actual Study Start Date :||October 5, 2018|
|Actual Primary Completion Date :||July 14, 2020|
|Actual Study Completion Date :||July 14, 2020|
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
Acthar gel for subcutaneous injection 80 units per mL (40 units per 0.5 mL)
Other Name: Corticotropin
- Score on the Nussenblatt Grading Scale [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
- Diurnal Intraocular Pressure (IOP) [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03656692
|United States, Florida|
|Blue Ocean Clinical Research|
|Clearwater, Florida, United States, 33761|
|United States, Indiana|
|Midwest Eye Institute|
|Indianapolis, Indiana, United States, 46290|
|United States, Massachusetts|
|Massachusetts Eye Research and Surgery Institution (MERSI)|
|Waltham, Massachusetts, United States, 02451|
|United States, New Jersey|
|Metropolitan Eye Research and Surgery Institute|
|Palisades Park, New Jersey, United States, 07650|
|United States, North Dakota|
|Bergstrom Eye Research, LLC|
|Fargo, North Dakota, United States, 58103|
|United States, Texas|
|Valley Retina Institute, PA|
|McAllen, Texas, United States, 78503|
|Foresight Studies, LLC|
|San Antonio, Texas, United States, 78240|
|United States, Virginia|
|Virginia Eye Consultants|
|Norfolk, Virginia, United States, 23502|
|Study Director:||Clinical Team Lead||Mallinckrodt|