3 Clinical Trials for Various 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.
This study will identify patients with anterior segment disease who may be eligible to participate in current or future NEI studies on this disease. Anterior segment disease includes all disorders that affect the eye surface, anterior chamber, iris and ciliary body and lens of the eye. The eye surface is composed of the cornea, conjunctiva, eyelids, lacrimal and meibomian glands, and the interconnecting nerves. Patients of any age with anterior segment disease may be eligible for this screening study. Participants will be evaluated with some or all of the following tests and procedures, depending on the nature of their eye problem: * Medical history and brief physical examination. * Eye examination, including measurement of visual acuity (eye chart) and eye pressure, examination of the pupils, eye movements, structures in the front of the eye (cornea, conjunctive, etc.), the lens, and the structures in the back of the eye (retinal, optic nerve, etc.). * Photographs of the eye to help assess the status of the cornea and conjunctive and to evaluate any changes that may occur in the future. * Assessment of tear and surface status. The amount of tears the eyes can produce is measured by placing a small piece of sterile paper in the corner of the eye every 5 minutes. Special orange and green dyes are placed in the eyes to determine the health status of the surface of the eye. * Corneal or conjunctival biopsy. A small tissue sample from the surface of the eye may be removed for laboratory examination to help diagnose a condition that is unclear. For this procedure, the eye is numbed with anesthetic eye drops. The required tissue is collected, an antibiotic ointment is placed in the eye to prevent infection, and a patch may be placed over the eye for 12 to 24 hours. * Blood draw for tests to study the cause of the patient's eye disease. * Other diagnostic tests as needed. * DNA testing to look for a genetic pattern associated with the patient's eye disease. Patients who are found eligible for an NEI study will be offered participation in that study. Patients who are not eligible for current studies will be advised about treatment options.
The Use of Two YUTIQ versus Sham for Treatment of Chronic Non Infectious Intraocular Inflammation Affecting the Posterior Segment (TYNI Trial)