This trial is studying the safety and tolerability of receiving an injection of adalimumab (Humira) during the Boston Keratoprosthesis (KPro) surgery.
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
Active tuberculosis or untreated latent tuberculosis (e.g., positive interferon-# release assay [IGRA] test, such as Quantiferon-gold)
Untreated active hepatitis B or C infection.
Ocular or periocular malignancy and/or infection
Inability to wear contact lens
Single group
Adalimumab Injection
Drug10% (4.0mg/0.04ml) dissolved in sterile saline to be injected once during the time of the Boston Keratoprosthesis (Kpro) Surgery.
Evaluation of Treatment Related Adverse Events.
To evaluate safety following subconjunctival injection of adalimumab at the time of keratoprosthesis surgery in patients who have corneal problems of such severity that they require keratoprosthesis implantation. The incidence, severity, and duration of adverse events will be assessed and documented. Because the subjects in this study have corneal problems of such severity that they require keratoprosthesis implantation, special attention will be given to adverse events of particular concern, such as microbial keratitis, subconjunctival hemorrhage, subconjunctival inflammation, or retinal necrosis or retinal detachment
Efficacy of adalimumab Injection though changes in visual acuity.
This efficacy outcome measure will be analyzed though changes of any worsening of the best corrective visual acuity by 15 letters at every study visit.
Efficacy of adalimumab Injection though changes in Optic Nerve Cup-to-Disk Ratio
This efficacy outcome measure will be analyzed through any changes to the cup-to-disk ratio. A normal ratio is 0.2mm
Efficacy of adalimumab Injection through incidences of Intraocular Inflammation
This efficacy outcome measure will be analyzed though any incidences of intraocular inflammation that occurs post implantation/injection.
Efficacy of adalimumab Injection through changes in the Ocular Coherence Tomography (OCT) of the Optic Nerves
This efficacy outcome measure will be analyzed though any changes in the retinal nerve fiber layer thickness (nerve edema).
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