N/A
N=9
Ocular Sarcoidosis Open Label Trial of ACTHAR Gel
Ocular Sarcoidosis · Panuveitis · Anterior Uveitis
Bottom Line
View on ClinicalTrials.gov: NCT02725177 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Feb 2023
Primary outcome: Primary: Percentage of Patients With Clinically Significant Improvement in Visual Acuity — 3 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Repository Corticotropin Injection (Drug); Repository Corticotropin Injection -Treatment Extension (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The Cleveland Clinic
- Primary completion
- Dec 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients With Clinically Significant Improvement in Visual Acuity |
3 | — |
| SECONDARY Percentage of Patients With Clinically Significant Improvement in the Resolution-intraocular Inflammation |
2 | — |
| SECONDARY Proportion of Patients Experiencing a Tapering of Ocular/Oral Steroids by at Least 50% |
2 | — |
| SECONDARY Proportion of Patients With a Clinically Significant Reduction-cystoid Macular Edema |
1 | — |
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)
Eligibility Criteria
Inclusion Criteria
- Patient with sarcoidosis as defined by ATS/ERS/WASOG guidelines (American Thoracic Society/European Respiratory Society /World Association of Sarcoidosis and Other Granulomatous Diseases)
- Any posterior, intermediate or panuveitis of sufficient severity to warrant therapy, in the opinion of the treating physician --OR-- Anterior uveitis requiring 4 or more daily applications of topical corticosteroids to maintain control of inflammation, or uncontrolled with topical therapy
- Persistent disease activity (active uveitis) at the time of screening
Exclusion Criteria
- Other cause for ocular inflammation
- Uncontrolled diabetes, hypertension, or other contra-indication to increased dosage of glucocorticoids
- Recent (less than 4 weeks) intra-ocular or intra-orbital steroid injection
- Escalation of immunosuppressive medications between screening and initiation of the study medication
- Severe extra-ocular sarcoidosis likely to require additional therapy (in the opinion of the investigator)
- Administration of an investigational medication for sarcoidosis within 3 months, or 5 half-lives, whichever is longer
- Have a history of any opportunistic infection within 6 months prior to screening
- Have any history of malignancy, except fully resected cutaneous squamous cell cancer or cutaneous basal cell cancer, or cervical carcinoma in-situ with a minimum of 5 years period without recurrence
- Severe other organ disease felt to be likely to lead to death within the next six months
- Unable to follow the study protocol, including the requisite travel and follow-up ocular testing
- Women of childbearing potential must be using adequate birth control measures (abstinence, hormonal contraceptives, intrauterine device, barrier method with spermicide, or surgical sterilization) and must agree to continue such precautions, and not become pregnant or plan a pregnancy for 6 months after receiving their last treatment with study agent. Women of childbearing potential must test negative on a serum pregnancy test at screening.
- Breastfeeding women are excluded from participation
Data sourced from ClinicalTrials.gov (NCT02725177). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.