Corneal Neovascularization Clinical Trial
Official title:
Subconjunctival IVIg (Gamunex-C) Injection for Corneal Neovascularization and Inflammatory Conditions
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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