Open Label Study of Acthar SQ Gel Injection in Patients With Active Anterior Uveitis
| Status: | Terminated |
|---|---|
| Conditions: | Cervical Cancer, Ocular, Ocular |
| Therapuetic Areas: | Oncology, Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/3/2018 |
| Start Date: | June 2016 |
| End Date: | January 6, 2017 |
Prospective Open Label Study of Acthar SQ Gel Injection in Patients With Active Anterior Uveitis Who Are Not Well Controlled With, or Intolerant of, Topical or Systemic Corticosteroids
Uveitis is an acute or chronic inflammatory condition of unknown etiology. Although uveitis
often responds adequately to topical corticosteroids, there are many patients for which this
treatment is either inadequate or not tolerated. A patient with inadequate response to
treatment would manifest uveitis activity by slit lamp examination determination of anterior
chamber cellularity. Lack of tolerance of therapy commonly manifests as ocular hypertension
(greater than 21 mmHg measured by tonometry)complicating chronic topical corticosteroid
administration, leading to glaucoma and permanent visual loss. Moreover, systemic
corticosteroids may be required at a dose unsafe for chronic administration. In these
situations, an immunosuppressive medication is often added as a "steroid-sparing" agent. If
and when there is clinical response to the added immunosuppressive, the oral and/or topical
corticosteroid dose can be reduced or eliminated to avoid toxicity.
There are several reasons for believing that Acthar might be beneficial in the treatment of
uveitis patients. In addition to increasing adrenal production or cortisol, Acthar has
another important mechanisms of action mediated by its binding of melanocortin receptors.
Melanocortin down-regulates activity of B and T lymphocytes, monocytes and macrophages. In
animal studies, melanocortin peptides down-regulate T helper cells, up-regulate T Regulatory
cells, and decrease B lymphocyte production of B Lymphocyte Stimulator. In macrophages, there
is down-regulation of IL-1, IL-2, INF gamma, TNF alpha, nitric oxide and adhesion molecules.
In other cells, in addition to IL-10 upregulation (monocytes), there is down-regulation of
VACM and ECAM (endothelial cells), prostaglandins (fibroblasts) and MCP-1 and RANTES (renal
tubules).CNS mediation of systemic inflammation may also be down-regulated by melanocortin
receptor binding by Acthar.
often responds adequately to topical corticosteroids, there are many patients for which this
treatment is either inadequate or not tolerated. A patient with inadequate response to
treatment would manifest uveitis activity by slit lamp examination determination of anterior
chamber cellularity. Lack of tolerance of therapy commonly manifests as ocular hypertension
(greater than 21 mmHg measured by tonometry)complicating chronic topical corticosteroid
administration, leading to glaucoma and permanent visual loss. Moreover, systemic
corticosteroids may be required at a dose unsafe for chronic administration. In these
situations, an immunosuppressive medication is often added as a "steroid-sparing" agent. If
and when there is clinical response to the added immunosuppressive, the oral and/or topical
corticosteroid dose can be reduced or eliminated to avoid toxicity.
There are several reasons for believing that Acthar might be beneficial in the treatment of
uveitis patients. In addition to increasing adrenal production or cortisol, Acthar has
another important mechanisms of action mediated by its binding of melanocortin receptors.
Melanocortin down-regulates activity of B and T lymphocytes, monocytes and macrophages. In
animal studies, melanocortin peptides down-regulate T helper cells, up-regulate T Regulatory
cells, and decrease B lymphocyte production of B Lymphocyte Stimulator. In macrophages, there
is down-regulation of IL-1, IL-2, INF gamma, TNF alpha, nitric oxide and adhesion molecules.
In other cells, in addition to IL-10 upregulation (monocytes), there is down-regulation of
VACM and ECAM (endothelial cells), prostaglandins (fibroblasts) and MCP-1 and RANTES (renal
tubules).CNS mediation of systemic inflammation may also be down-regulated by melanocortin
receptor binding by Acthar.
Patients eligible for the study will be identified by the investigators and given a copy of
the consent form to read. Patients interested in enrolling will be screened and if eligible
will be enrolled in the study. The screening visit and the baseline visit may occur on the
same day. Patients enrolling will be instructed in self-administering Acthar 80 IU twice a
week. Patients will keep an injection log which will be inspected at each visit (4, 8, and 12
weeks). Ophthalmology data will be collected at each visit and recorded on the case report
form by the ophthalmology technician working with the sub-investigator at the time of each
visit. Patients will come to the Center for Clinical Studies each visit for blood draw, blood
pressure recording, and recording of adverse events.
the consent form to read. Patients interested in enrolling will be screened and if eligible
will be enrolled in the study. The screening visit and the baseline visit may occur on the
same day. Patients enrolling will be instructed in self-administering Acthar 80 IU twice a
week. Patients will keep an injection log which will be inspected at each visit (4, 8, and 12
weeks). Ophthalmology data will be collected at each visit and recorded on the case report
form by the ophthalmology technician working with the sub-investigator at the time of each
visit. Patients will come to the Center for Clinical Studies each visit for blood draw, blood
pressure recording, and recording of adverse events.
Inclusion Criteria:
- Active anterior uveitis requiring oral and/or topical corticosteroid therapy
Exclusion Criteria:
- Uncontrolled diabetes
- Uncontrolled glaucoma
- HIV infection or other infection for which corticosteroid therapy contraindicated
- Contraindication to ACTHAR
- Scleroderma
- Osteoporosis
- Ocular herpes simplex
- Systemic fungal infection
- Recent surgery
- Uncontrolled hypertension
We found this trial at
1
site
Click here to add this to my saved trials
