Safety and Effectiveness of Acthar Gel for Inflammation of the Eye's Uvea (Middle Layer)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03656692|
Recruitment Status : Recruiting
First Posted : September 4, 2018
Last Update Posted : February 25, 2020
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)|
|Estimated Enrollment :||30 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|
|Estimated Primary Completion Date :||July 16, 2022|
|Estimated Study Completion Date :||July 16, 2022|
Participants receive Acthar Gel as follows: 1 mL 2x/week for 36 weeks, followed by a taper to 1 mL/week for two weeks, and then 0.5 mL/week for an additional 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 Nussemblatt Grading Scale [ Time Frame: Week 36 ]The Nussemblatt 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.
- Number of participants with an adverse event [ Time Frame: Week 36 ]Clinically significant changes in clinical and ocular measurements are considered adverse events.
- 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
|Contact: For information about participating||800-556-3314 ext email@example.com|
|United States, Arizona|
|Retinal Research Institute, LLC||Withdrawn|
|Phoenix, Arizona, United States, 85014|
|Retina Center PC||Withdrawn|
|Tucson, Arizona, United States, 85704|
|United States, Florida|
|Blue Ocean Clinical Research||Recruiting|
|Clearwater, Florida, United States, 33761|
|United States, Illinois|
|University Retina and Macula Associates PC||Withdrawn|
|Lemont, Illinois, United States, 60439|
|United States, Indiana|
|Midwest Eye Institute||Recruiting|
|Indianapolis, Indiana, United States, 46290|
|United States, Massachusetts|
|Massachusetts Eye Research and Surgery Institution (MERSI)||Recruiting|
|Waltham, Massachusetts, United States, 02451|
|United States, New Jersey|
|Metropolitan Eye Research and Surgery Institute||Recruiting|
|Palisades Park, New Jersey, United States, 07650|
|Metropolitan Eye Research and Surgery Institute||Withdrawn|
|Teaneck, New Jersey, United States, 07666|
|United States, North Dakota|
|Bergstrom Eye Research, LLC||Recruiting|
|Fargo, North Dakota, United States, 58103|
|United States, Texas|
|Austin Retina Associates||Withdrawn|
|Austin, Texas, United States, 78705|
|Valley Retina Institute, PA||Recruiting|
|McAllen, Texas, United States, 78503|
|Foresight Studies, LLC||Recruiting|
|San Antonio, Texas, United States, 78240|
|United States, Virginia|
|Virginia Eye Consultants||Recruiting|
|Norfolk, Virginia, United States, 23502|
|Study Director:||Clinical Team Lead||Mallinckrodt|