Ignite Creation Date:
2024-05-06 @ 8:32 AM
Last Modification Date:
2024-10-26 @ 12:01 PM
Study NCT ID:
NCT02764697
Status:
COMPLETED
Last Update Posted:
2018-07-02
First Post:
2016-04-25
Brief Title:
Study of HP ACTHAR Subcutaneous Gelatin GelHighly Purified Gel Injection in Uveitis Patients
Sponsor:
Tampa Bay Uveitis Center LLC
Organization:
Tampa Bay Uveitis Center LLC
Study Overview
Official Title:
Prospective Open Label Study of HP 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
Status:
COMPLETED
Status Verified Date:
2018-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 pressureThis pilot study aims to evaluate the possible effectiveness of HP 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
HP Acthar Gel stimulate the adrenal cortex to secrete cortisol Additionally HP 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 HP 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 pressureThis pilot study aims to evaluate the possible effectiveness of HP 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 Uml 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 activityquiescence and safety assessment
HP Acthar Gel stimulate the adrenal cortex to secrete cortisol Additionally HP 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 HP 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 pressureThis pilot study aims to evaluate the possible effectiveness of HP 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 Uml 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 activityquiescence and safety assessment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None