Ocular Sarcoidosis Open Label Trial of ACTHAR Gel

NCT02725177 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2023-11-14

Study results available
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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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02725177 on ClinicalTrials.gov