Massachusetts Eye and Ear Infirmary
This trial is studying the safety and tolerability of receiving an injection of adalimumab (Humira) during the Boston Keratoprosthesis (KPro) surgery.
This is a Phase I, Open-label, IND trial for participants undergoing a Boston Keratoprosthesis (KPro) procedure, to receive an injection of adalimumab (Humira), to study the safety and tolerability as well, to study whether there is a decrease to post surgical complications, and symptoms that participants would experience, if they did not receive the injection. The study will recruit eight (8) participants, who will be monitored for thirty (30) days after the surgery, through eye examination and eye photos.
Inclusion Criteria: * Age 18 years or older * Individuals eligible for keratoprosthesis surgery, as determined by standard-of-care eligibility criteria * Patients with poor prognosis for corneal transplantation, severe corneal opacity and/or vascularization * Patients with vision worse than 20/200 in the eligible eye, and contralateral eye with vision less than 20/40 * Patients with intact nasal light projection * Willing and able to comply with study plan for the full duration of the study * Willing and able to sign a written informed consent Exclusion Criteria: * Active tuberculosis or un…
10% (4.0mg/0.04ml) dissolved in sterile saline to be injected once during the time of the Boston Keratoprosthesis (Kpro) Surgery.
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