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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
10% (4.0mg/0.04ml) dissolved in sterile saline to be injected once during the time of the Boston Keratoprosthesis (Kpro) Surgery.
Massachusetts Eye and Ear
Boston, Massachusetts, United States
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
Time frame: 30 Days
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.
Time frame: 30 Days
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
Time frame: Every Two (2) Weeks After Implantation/Injection until Day 30
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.
Time frame: 30 Days
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).
Time frame: 30 Days
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Efficacy of adalimumab Injection though changes in the ocular coherence tomography (OCT) of the Retina
This efficacy outcome measure will be analyzed though increases in the foveal retinal thicknesses by an increase of more than (\>)100um in comparison to the previous study visit(s).
Time frame: 30 Days