Ocular Sarcoidosis Open Label Trial of ACTHAR Gel
NCT02725177 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9
Last updated 2023-11-14
Summary
Treatment with ACTHAR Gel will result in a reduction of ocular inflammation in patients with active ocular sarcoidosis that requires systemic immunosuppressant therapy (hypothesis)
Conditions
- Ocular Sarcoidosis
- Panuveitis
- Anterior Uveitis
Interventions
- DRUG
-
Repository Corticotropin Injection
Treatment with ACTHAR Gel for 24 weeks * Initial treatment with 80 units daily for ten days (induction phase) * Maintenance treatment with 80 units twice weekly (maintenance phase)
- DRUG
-
Repository Corticotropin Injection -Treatment Extension
24 open label extension permitted in subjects who respond to treatment
Sponsors & Collaborators
-
Mallinckrodt
collaborator INDUSTRY -
The Cleveland Clinic
lead OTHER
Principal Investigators
-
Daniel A Culver, DO · The Cleveland Clinic
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 99 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-07-31
- Primary Completion
- 2021-12-31
- Completion
- 2022-03-31
Countries
- United States
Study Locations
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