A Phase 4 interventional study of H.P. ACTHAR SUBCUTANEOUS GEL INJECTION in Uveitis, Anterior Uveitis and Intermediate Uveitis, sponsored by Tampa Bay Uveitis Center, LLC. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-07-02.
Sponsored by Tampa Bay Uveitis Center, LLC · Phase 4, Interventional, and Treatment
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.
299 studies on the registry are indexed under Uveitis; 32 are open to participants now.
This study's enrollment of 6 is below the median of 30 across 175 interventional studies indexed under Uveitis.
Browse Uveitis studies →Tampa Bay Uveitis Center, LLC is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: H.P. ACTHAR SUBCUTANEOUS GEL INJECTION
Subcutaneous injection twice weekly
Also known as: Acthar
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
Time frame: 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
Time frame: 12 weeks
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
| Milestone | H.P. Acthar Subcutaneous Gel Injection |
|---|---|
| Started | 5 |
| Completed | 2 |
| Not completed | 3 |
| Withdrew: Lack of efficacy | 3 |
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
| Participants | H.P. Acthar Subcutaneous Gel Injection |
|---|---|
| 1 Step of VH Improvement | 3 |
| 2 Step of VH | 1 |
| No VH Improvement | 1 |
Clinically Significant Uveitic Macular Edema: Clinical Improvement of Macular Edema with OCT Documentation of central foveal thickness \< 300 microns
| Participants | H.P. Acthar Subcutaneous Gel Injection |
|---|---|
| Decrease in Central Foveal Thickness <300 | 0 |
| Decrease in central Fovea > 300 Microns | 5 |
Collected over 3 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| H.P. Acthar Subcutaneous Gel Injection | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Age, Categorical(Participants) | H.P. Acthar Subcutaneous Gel Injection |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 4 |
| >=65 years | 1 |
| Sex: Female, Male(Participants) | H.P. Acthar Subcutaneous Gel Injection |
|---|---|
| Female | 3 |
| Male | 2 |
| Race (NIH/OMB)(Participants) | H.P. Acthar Subcutaneous Gel Injection |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 4 |
| White | 1 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | H.P. Acthar Subcutaneous Gel Injection |
|---|---|
| United States | 5 |
Plan to share: No
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This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Adrenocorticotropic Hormone
Tampa Bay Uveitis Center, LLC