Subconjunctival IVIg (Gamunex-C) Injection for Corneal Neovascularization and Inflammatory Conditions
| Status: | Recruiting |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | July 2014 |
| End Date: | October 2017 |
| Contact: | Elizabeth Nuttall |
| Email: | elizabeth.nuttall@hsc.utah.edu |
| Phone: | (801) 213-3461 |
The purpose of the study is to test the investigational drug Gamunex-C on the growth of
blood vessels over the cornea. This study is being conducted by Dr. Balamurali Ambati at the
Moran Eye Center at the University of Utah.
The cornea is the clear outer front part of the eye. In corneal neovascularization, blood
vessels grow over the cornea. Corneal neovascularization and ocular anterior segment
inflammations are sight-threatening conditions. Lipid deposition and edema with subsequent
scar formation can compromise corneal clarity irreversibly. Corneal neovascularization is
also a well recognized risk factor for corneal graft failure. In its natural state, the
cornea is a site of immune privilege well suited to tissue transplantation. Once
vascularized, there is direct exposure of corneal antigens to circulating host immune
mechanisms greatly increasing the chance of rejection [Collaborative Corneal Transplantation
Study].
Melting or inflammation in the anterior chamber, cornea, or ocular surface can cause
irreversible scarring or destruction of the optical elements of the eye, which can
compromise vision.
Current standard of care for such conditions includes use of topical steroids and sometimes
immunosuppressants (e.g., cyclosporine). These do not address a common underlying corneal
neovascularization or melting.
This is a Phase 1 clinical trial of subconjunctival IVIg (Gamunex-C) injection for treatment
of corneal neovascularization in the setting of corneal transplantation with
neovascularization. Candidates for corneal transplantation with corneal neovascularization
in one or more quadrants crossing more than 0.5mm over the limbus will be identified for
inclusion in our study.
blood vessels over the cornea. This study is being conducted by Dr. Balamurali Ambati at the
Moran Eye Center at the University of Utah.
The cornea is the clear outer front part of the eye. In corneal neovascularization, blood
vessels grow over the cornea. Corneal neovascularization and ocular anterior segment
inflammations are sight-threatening conditions. Lipid deposition and edema with subsequent
scar formation can compromise corneal clarity irreversibly. Corneal neovascularization is
also a well recognized risk factor for corneal graft failure. In its natural state, the
cornea is a site of immune privilege well suited to tissue transplantation. Once
vascularized, there is direct exposure of corneal antigens to circulating host immune
mechanisms greatly increasing the chance of rejection [Collaborative Corneal Transplantation
Study].
Melting or inflammation in the anterior chamber, cornea, or ocular surface can cause
irreversible scarring or destruction of the optical elements of the eye, which can
compromise vision.
Current standard of care for such conditions includes use of topical steroids and sometimes
immunosuppressants (e.g., cyclosporine). These do not address a common underlying corneal
neovascularization or melting.
This is a Phase 1 clinical trial of subconjunctival IVIg (Gamunex-C) injection for treatment
of corneal neovascularization in the setting of corneal transplantation with
neovascularization. Candidates for corneal transplantation with corneal neovascularization
in one or more quadrants crossing more than 0.5mm over the limbus will be identified for
inclusion in our study.
Inclusion Criteria:
1. Candidates for corneal transplantation (only one eye per patient would be enrolled)
2. Patients with corneal neovascularization in one or more quadrants crossing more than
1.0 mm over the limbus at time of enrollment in the study
3. Patients with refractory anterior uveitis, non-responding corneal melts, or
non-responding ocular cicatricial pemphigoid
4. Willing and able to comply with clinic visits and study-related procedures
5. Provide signed informed consent
6. Age 18 or over
Exclusion Criteria:
1. Patients receiving antiangiogenic anti-VEGF medication either systemically or
intravitreally for other pathology or who have received these drugs within 3 months
of study enrollment
2. Patients with active corneal infection requiring additional treatment modalities
3. Patients receiving coumadin with INR >2.0, other anti-thrombotic agents (e.g.,
aspirin, Plavix) permitted at discretion of investigator
4. History of CVA or MI within 6 months prior to study enrollment
5. Uncontrolled BP- defined as SBP>160 mmHg or DBP >95mmHg while patient is sitting
6. Pregnant or breast-feeding women
7. Sexually active men* or women of childbearing potential** who are unwilling to
practice adequate contraception during the study (adequate contraceptive measures
include stable use of oral contraceptives or other prescription pharmaceutical
contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device
[IUD]; bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam,
or jelly, or diaphragm plus contraceptive sponge, foam, or jelly) *Contraception is
not required for men with documented vasectomy. **Postmenopausal women must be
amenorrheic for at least 12 months in order not to be considered of child bearing
potential. Pregnancy testing and contraception are not required for women with
documented hysterectomy or tubal ligation.
We found this trial at
1
site
Salt Lake City, Utah 84132
Principal Investigator: Balamurali K. Ambati, M.D., Ph.D., M.B.A.
Click here to add this to my saved trials
