Ocular Sarcoidosis Open Label Trial of ACTHAR Gel
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|ClinicalTrials.gov Identifier: NCT02725177|
Recruitment Status : Recruiting
First Posted : March 31, 2016
Last Update Posted : February 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Ocular Sarcoidosis Panuveitis Anterior Uveitis||Drug: Repository Corticotropin Injection Drug: Repository Corticotropin Injection -Treatment Extension||Not Applicable|
The initial treatment of ocular sarcoidosis usually relies on a combination of topical glucocorticoids and oral glucocorticoids, both of which are associated with significant ocular and systemic toxicities. Steroid-sparing therapies are limited by variable and unpredictable efficacy, prolonged time until clinical response, medication intolerance, and difficulties obtaining payor approval. As a result, it is not uncommon that treating physicians must choose between excessive glucocorticoid toxicity versus poor control of ocular inflammation. Ongoing ocular inflammation, in turn, leads to eventual visual loss and occasionally blindness.
There is a need for a more reliable, expeditious therapy that can be used as an alternative to glucocorticoids in sarcoidosis uveitis. Adrenocorticotropic hormone, through activation of melanocortin receptors on leukocytes, can dampen immune responses through non-glucocorticoid dependent mechanisms. The proposed study will aim to define whether there is effectiveness for ACTHAR gel in these patients, delineate an effect dosing regimen, and provide information about the safety of this approach for moderate to severe ocular sarcoidosis.
ACTHAR is a 39-amino acid peptide natural form of adrenocorticotropin hormone (ACTH) that was initially approved in 1952 by the FDA. It has since been approved for 19 indications including respiratory sarcoidosis, multiple sclerosis, and infantile spasms.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Ocular Sarcoidosis Open Label Trial of ACTHAR Gel|
|Study Start Date :||March 2016|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
Experimental: H.P. Achtar Gel 80 U
H.P. Acthar Gel (repository corticotropin) Injection, 80 U daily for 10 days, then 80 U twice weekly for up to a total of 24 weeks on therapy.
Drug: Repository Corticotropin Injection
Treatment with ACTHAR Gel for 24 weeks
Drug: Repository Corticotropin Injection -Treatment Extension
24 open label extension permitted in subjects who respond to treatment
- Proportion of patients with clinically significant improvement in visual acuity [ Time Frame: Measured at 24 weeks ]
- Proportion of patients with clinically significant improvement in the resolution-intraocular inflammation [ Time Frame: Measured at 24 weeks ]
- Proportion of patients experiencing a tapering of ocular/oral steroids by at least 50% [ Time Frame: Measured at 24 weeks ]
- Proportion of patients with a clinically significant reduction-cystoid macular edema [ Time Frame: Measured at 24 weeks ]
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): NCT02725177
|Contact: Daniel A Culver, DOemail@example.com|
|United States, Ohio|
|Cleveland Clinical Foundation||Recruiting|
|Cleveland, Ohio, United States, 44145|
|Principal Investigator:||Daniel A Culver, DO||The Cleveland Clinic|