Ocular Sarcoidosis Open Label Trial of ACTHAR Gel

• Register: ClinicalTrials.gov
• Last refreshed on: 20 November 2023
• Main ID: NCT02725177
• Date of registration: 11/03/2016
• Prospective Registration: Yes
• Primary sponsor: The Cleveland Clinic
• Public title: Ocular Sarcoidosis Open Label Trial of ACTHAR Gel
• Scientific title: Ocular Sarcoidosis Open Label Trial of ACTHAR Gel
• Date of first enrolment: July 2016
• Target sample size: 9
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT02725177
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Daniel A Culver, DO
• Affiliation: The Cleveland Clinic

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 99 Years
Gender: All

Health Condition(s) or Problem(s) studied

Anterior Uveitis

Ocular Sarcoidosis

Panuveitis

Intervention(s)

Drug: Repository Corticotropin Injection

Drug: Repository Corticotropin Injection -Treatment Extension

Primary Outcome(s)

Percentage of Patients With Clinically Significant Improvement in Visual Acuity [Time Frame: Measured at 24 weeks]

Secondary Outcome(s)

Proportion of Patients With a Clinically Significant Reduction-cystoid Macular Edema [Time Frame: Measured at 24 weeks]

Percentage 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]

Secondary ID(s)

Ocular Sarcoidosis 15-1072

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Mallinckrodt

Results

• Results available: Yes
• Date Posted: 15/02/2023
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02725177