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Study of H.P. ACTHAR Subcutaneous Gelatin (Gel)(Highly Purified Gel Injection) in Uveitis Patients

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ClinicalTrials.gov Identifier: NCT02764697
Recruitment Status : Completed
First Posted : May 6, 2016
Results First Posted : July 2, 2018
Last Update Posted : July 2, 2018
Sponsor:
Collaborator:
Mallinckrodt
Information provided by (Responsible Party):
Tampa Bay Uveitis Center, LLC

Tracking Information
First Submitted Date  ICMJE April 25, 2016
First Posted Date  ICMJE May 6, 2016
Results First Submitted Date  ICMJE November 23, 2017
Results First Posted Date  ICMJE July 2, 2018
Last Update Posted Date July 2, 2018
Actual Study Start Date  ICMJE June 30, 2016
Actual Primary Completion Date December 7, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 29, 2018)
  • Number of Participants With Photographic Haze Reduced to Grade 0 or Down 2 Steps Documented With Fundus Photography [ Time Frame: 12 Weeks ]
    Subjects will have fundus photography at baseline and 12 weeks. Intermediate uveitis is graded by haze; it is done using the photographic scale: grades 0-4 (lower values are a better outcome), utilized by the SUN criteria, based on the Nussenblatt photographic vitreous haze scale
  • Number of Participants With Clinically Significant Improvement of Macular Edema [ Time Frame: 12 weeks ]
    Clinically Significant Uveitic Macular Edema: Clinical Improvement of Macular Edema with OCT Documentation of central foveal thickness < 300 microns
Original Primary Outcome Measures  ICMJE
 (submitted: May 3, 2016)
  • Resolution of Inflammation: Anterior Uveitis [ Time Frame: 12 weeks ]
    2 step decrease in inflammatory score or down to grade 0 (Standardization of Uveitis Nomenclature, standardized and published for reporting clinical trials in uveitis:SUN criteria): Using the SUN criteria, inflammation can be graded on a scale from 0-4: subjects will be graded at baseline; resolution will graded as achieving the primary endpoint when the score decreases by 2 steps on the scale, or goes down to grade 0
  • Resolution of Inflammation: Retinal Vasculitis [ Time Frame: 12 weeks ]
    Clinical improvement of vasculitis, corroborated by angiographic evaluation: subjects with retinal vasculitis will have a retinal angiogram called a fluorescein angiogram at baseline and week 12, this will document areas of retinal vascular inflammation: Resolution will be graded at 12 weeks based on retinal leakage resolution on the fluorescein angiogram
  • Resolution of Inflammation:Intermediate Uveitis: Photographic haze reduced to grade 0 or down 2 steps documented with fundus photography [ Time Frame: 12 Weeks ]
    Subjects will have fundus photography at baseline and 12 weeks. Intermediate uveitis is graded by haze; it is done using the photographic scale: grades 0-4, utilized by the SUN criteria, based on the Nussenblatt photographic vitreous haze scale
  • Resolution of Inflammation: Clinically Significant Uveitic Macular Edema: Clinical improvement of macular edema with optical coherence tomography (OCT), which measures retinal thickness; documentation of central foveal thickness < 300 microns [ Time Frame: 12 weeks ]
    Subjects will have optical coherence tomography done at baseline and 12 weeks; decrease in foveal thickness to < 300microns will be documented as resolution of clinically significant uveitic macular edema
  • Resolution of Inflammation: Scleritis: 2 step decrease or down to grade 0 improvement of with photographic documentation [ Time Frame: 12 weeks ]
    Resolution of scleritis inflammation will be assessed by comparing baseline graded photographs compared to graded photographs at 12 weeks, utilizing the published standardized Sen grading scale for scleritis.
  • Resolution of Inflammation: Resolution of retinal and choroidal infiltrate with photographic documentation [ Time Frame: 12 weeks ]
    Subjects will have photos at baseline and 12 weeks if they have posterior uveitis; the resolution of retinal and choroidal lesions will be documented by photographs
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: May 3, 2016)
Change in visual acuity [ Time Frame: 12 and 24 weeks ]
The visual acuity of subjects will be measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart. The ETDRS scores will be converted to a logarithmic scale, LogMar units, which will be utilized to calculate mean and median change in visual acuity score from baseline to 12 and 24 weeks
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of H.P. ACTHAR Subcutaneous Gelatin (Gel)(Highly Purified Gel Injection) in Uveitis Patients
Official Title  ICMJE Prospective Open Label Study of H.P. Acthar Gel Injection in Patients With Active Non-Infectious Uveitis With Associated Glaucoma Thus High Frequency Regional Corticosteroid and Oral Corticosteroids Cause Intolerable Side-Effects
Brief Summary Uveitis represents a heterogeneous group of diseases that results from ocular inflammatory reaction involving ocular tissue and vasculature. The inflammation usually causes pain, redness, photophobia and blurred vision. This inflammation, is typically treated with regional or systemic therapy. The regional therapy typically consists of topical corticosteroids or periocular or regional corticosteroids. Regional therapy can lead to a steroid response glaucoma, which is increased intraocular pressure.This pilot study aims to evaluate the possible effectiveness of H.P. Acthar in patients with active ocular inflammatory disease, and currently on treatment for glaucoma or have a history of glaucoma.
Detailed Description

Uveitis represents a heterogeneous group of diseases that results from ocular inflammatory reaction involving ocular tissue and vasculature. The inflammation usually causes pain, redness, photophobia and blurred vision.

H.P Acthar Gel stimulate the adrenal cortex to secrete cortisol. Additionally H.P. Acthar gel is also reported to bind to melanocortin receptors. Melanocortin receptor activation has been shown to exert marked anti-inflammatory and immune-modulatory effects in animal studies, by modulating pro inflammatory cytokines, followed by induction of anti- inflammatory mediators and subsequent leukocyte migration. Specifically melanocortins down regulate Tumor Necrosis Factor (TNF) alpha, Interleukin (IL) -2, Interferon gamma and T-cell proliferation and upregulates IL-10 and regulatory T cells. For this reason H.P. Acthar is an approved treatment for ocular inflammatory disease.

Ocular inflammatory disease is typically treated with regional or systemic therapy. The regional therapy typically consists of topical corticosteroids or periocular or regional corticosteroids. Regional therapy can lead to a steroid response glaucoma, which is increased intraocular pressure.This pilot study aims to evaluate the possible effectiveness of H.P. Acthar in patients with active ocular inflammatory disease, and currently on treatment for glaucoma or have a history of glaucoma.

Subjects will be treated with H P Acthar subcutaneous gel, 40 U/ml, given twice weekly x 8 weeks, followed by once weekly x 4 weeks: a total 20 doses with the same cumulative units to be administered, using the approved route, with the option to do 4 additional doses if resolution is incomplete.

This will be a prospective open-label, non-randomized pilot study: 12 week treatment for active non-infectious uveitis, endpoint assessment and safety assessment; additional 12 week assessment for uveitis activity/quiescence and safety assessment.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Uveitis
  • Anterior Uveitis
  • Intermediate Uveitis
  • Posterior Uveitis
  • Scleritis
  • Clinically Significant Macular Edema
Intervention  ICMJE Drug: H.P. ACTHAR SUBCUTANEOUS GEL INJECTION
Subcutaneous injection twice weekly
Other Name: Acthar
Study Arms  ICMJE H.P. Acthar Subcutaneous Gel Injection
For the current protocol we are proposing, 40 U/ml, given twice weekly x 8 weeks, followed by once weekly x 4 weeks: a total 20 doses, using the approved route, with the option to do 4 additional doses if resolution is incomplete.
Intervention: Drug: H.P. ACTHAR SUBCUTANEOUS GEL INJECTION
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 3, 2016)
6
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 20, 2016
Actual Primary Completion Date December 7, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subject has the ability to understand and sign the informed consent document
  • Subject is 18 years of age or older
  • Subject can be male or female
  • Subject has negative Purified Protein Derivative (Tuberculosis skin test) or quantiferon TB Gold Test (blood test for TB) testing done in 3 months
  • Subject has active ocular inflammation in at least one eye
  • Subject has visual acuity in at least one eye of 20/400 or better.
  • Subject has a history of glaucoma or has actively treated glaucoma
  • Subject is willing and able to comply with the study procedures
  • Female subjects of childbearing potential must not be pregnant or breast-feeding, must have a negative pregnancy test at screening and must be willing to undergo pregnancy testing throughout the study

Exclusion Criteria:

  • Subject has any ocular infection
  • Subject has any systemic infection
  • Participant has documented immunocompromised or immune-incompetent state
  • Subject has any ocular co-morbidity than prevents assessment of intraocular inflammation
  • Subject has had any intra-ocular surgery in previous 6 weeks
  • Subject has any planned elective surgery ocular or systemic during study duration
  • Subject is pregnant or breast-feeding
  • Subject had a recent vaccination with live or attenuated vaccines
  • Subject has a sensitivity to Porcine derived proteins
  • Subject has a medical history which is a contraindication to receiving H.P. Acthar
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02764697
Other Study ID Numbers  ICMJE TBUC 10012015
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Tampa Bay Uveitis Center, LLC
Study Sponsor  ICMJE Tampa Bay Uveitis Center, LLC
Collaborators  ICMJE Mallinckrodt
Investigators  ICMJE
Principal Investigator: Grace L Clarke Tampa Bay Uveitis Center, LLC
PRS Account Tampa Bay Uveitis Center, LLC
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP