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Trial · Interventional

CompletedNot applicableResults postedRegistry data

Ocular Sarcoidosis Open Label Trial of ACTHAR Gel

NCTNCT02725177 (opens ClinicalTrials.gov in a new tab)Other idOcular Sarcoidosis 15-1072
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Not applicable
Enrollment
9 participants (actual)
Sponsor
The Cleveland Clinic · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
Jul 2016
Primary completion
Dec 2021
Completion
Mar 2022
First posted
31 Mar 2016 (estimated)
Last update posted
14 Nov 2023
Conditions
Ocular Sarcoidosis · Panuveitis · Anterior Uveitis

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2016201820202022
  1. N/A

    Ocular Sarcoidosis Open Label Trial of ACTHAR Gel

    NCT02725177

    Jul 2016 to Mar 2022

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

Treatment with ACTHAR Gel will result in a reduction of ocular inflammation in patients with active ocular sarcoidosis that requires systemic immunosuppressant therapy (hypothesis)

Interventions

  • Repository Corticotropin InjectionDrug
  • Repository Corticotropin Injection -Treatment ExtensionDrug

Arms1

  • 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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Percentage of Patients With Clinically Significant Improvement in Visual Acuity

    Time frame · Measured at 24 weeks

    Registry description

    The primary outcome was percentage of patients meeting at least one of the following variables 1) improved visual acuity, 2) resolution of intraocular inflammation, 3) ability to taper ocular or oral steroids by at least 50% or 4) reduction of cystoid macular edema, with no worsening of any single one and no need for additional sarcoidosis therapies at 24 weeks .

Secondary outcomes(3)

  1. Percentage of Patients With Clinically Significant Improvement in the Resolution-intraocular Inflammation

    Time frame · Measured at 24 weeks

  2. Proportion of Patients Experiencing a Tapering of Ocular/Oral Steroids by at Least 50%

    Time frame · Measured at 24 weeks

  3. Proportion of Patients With a Clinically Significant Reduction-cystoid Macular Edema

    Time frame · Measured at 24 weeks

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeCount of participants· Measured at 24 weeks

Percentage of Patients With Clinically Significant Improvement in Visual Acuity

GroupValue (Participants)
H.P. Achtar Gel 80 U3
Secondary and other outcome results(3)
Secondary outcomeCount of participants· Measured at 24 weeks

Percentage of Patients With Clinically Significant Improvement in the Resolution-intraocular Inflammation

GroupValue (Participants)
H.P. Achtar Gel 80 U2
Secondary outcomeCount of participants· Measured at 24 weeks

Proportion of Patients Experiencing a Tapering of Ocular/Oral Steroids by at Least 50%

GroupValue (Participants)
H.P. Achtar Gel 80 U2
Secondary outcomeCount of participants· Measured at 24 weeks

Proportion of Patients With a Clinically Significant Reduction-cystoid Macular Edema

GroupValue (Participants)
H.P. Achtar Gel 80 U1

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
H.P. Achtar Gel 80 UH.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. 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) Repository Corticotropin Injection -Treatment Extension: 24 open label extension permitted in subjects who respond to treatment0 / 90 / 97 / 9

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 99 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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