Subconjunctival IVIg (Gamunex-C) Injection for Corneal Neovascularization and Inflammatory Conditions
Corneal Neovascularization, Corneal Graft Failure, Anterior Segment Inflammation
About this trial
This is an interventional treatment trial for Corneal Neovascularization focused on measuring corneal neovascularization, Gamunex-C, IVI-g, anterior segment inflammation
Eligibility Criteria
Inclusion Criteria:
- Candidates for corneal transplantation (only one eye per patient would be enrolled)
- 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
- Patients with refractory anterior uveitis, non-responding corneal melts, or non-responding ocular cicatricial pemphigoid
- Willing and able to comply with clinic visits and study-related procedures
- Provide signed informed consent
- Age 18 or over
Exclusion Criteria:
- 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
- Patients with active corneal infection requiring additional treatment modalities
- Patients receiving coumadin with INR >2.0, other anti-thrombotic agents (e.g., aspirin, Plavix) permitted at discretion of investigator
- History of CVA or MI within 6 months prior to study enrollment
- Uncontrolled BP- defined as SBP>160 mmHg or DBP >95mmHg while patient is sitting
- Pregnant or breast-feeding women
- 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.
Sites / Locations
- John A. Moran Eye Center
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Group A
Group B
Gamunex-C 50 mg subconjunctival injections, in addition to standard of care treatment (steroids and cyclosporine). One dose of Gamunex-C injection delivered four weeks prior to corneal transplant surgery and one dose at the time of corneal transplantation. Dose to be repeated if recurrence of corneal neovascularization
Gamunex-C 50 mg subconjunctival injections, one dose injected for patients with active disease from corneal melts (peripheral ulcerative keratitis; Mooren's ulcer), ocular cicatricial pemphigoid, or anterior uveitis refractory to conventional therapy.