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| Name | Class |
|---|---|
| Mallinckrodt | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| H.P. Acthar Subcutaneous Gel Injection | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| H.P. ACTHAR SUBCUTANEOUS GEL INJECTION | Drug | Subcutaneous injection twice weekly |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Photographic Haze Reduced to Grade 0 or Down 2 Steps Documented With Fundus Photography | 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 | 12 Weeks |
| Number of Participants With Clinically Significant Improvement of Macular Edema | Clinically Significant Uveitic Macular Edema: Clinical Improvement of Macular Edema with OCT Documentation of central foveal thickness < 300 microns | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Grace L Clarke | Tampa Bay Uveitis Center, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tampa Bay Uveitis Center | St. Petersburg | Florida | 33709 | United States |
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The patient after consent was given, were required to have their medical records reviewed and have screening laboratory evaluations
The recruitment period was 06/31/2016 through 08/10/2016
Active follow-up period 06/31/2016 through 12/07/2016
The study was conducted at 1 site Tampa Bay Uveitis Center, LLC 5800 49th Street North, St Petersburg Fl 33709: Outpatient Medical Clinic
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. H.P. ACTHAR SUBCUTANEOUS GEL INJECTION: Subcutaneous injection twice weekly |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. H.P. ACTHAR SUBCUTANEOUS GEL INJECTION: Subcutaneous injection twice weekly |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Photographic Haze Reduced to Grade 0 or Down 2 Steps Documented With Fundus Photography | 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 | Posted | Count of Participants | Participants | 12 Weeks |
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| Primary | Number of Participants With Clinically Significant Improvement of Macular Edema | Clinically Significant Uveitic Macular Edema: Clinical Improvement of Macular Edema with OCT Documentation of central foveal thickness < 300 microns | 0 | Posted | Count of Participants | Participants | 12 weeks |
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3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. H.P. ACTHAR SUBCUTANEOUS GEL INJECTION: Subcutaneous injection twice weekly | 0 | 5 | 0 | 5 | 0 | 5 |
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Small sample size
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Grace Levy Clarke | Tampa Bay Uveitis Center, LLC | 855 798 8393 | grace@tampabayuveitis.com |
| ID | Term |
|---|---|
| D014605 | Uveitis |
| D014606 | Uveitis, Anterior |
| D015867 | Uveitis, Intermediate |
| D015866 | Uveitis, Posterior |
| D015423 | Scleritis |
| ID | Term |
|---|---|
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
| D015864 | Panuveitis |
| D015422 | Scleral Diseases |
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| ID | Term |
|---|---|
| D000324 | Adrenocorticotropic Hormone |
| ID | Term |
|---|---|
| D053486 | Melanocortins |
| D011333 | Pro-Opiomelanocortin |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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