A Phase 1 interventional study of Adalimumab Injection in Penetrating Keratoplasty, Multiple Graft Failure and Ocular Cicatricial Pemphigoid, sponsored by Massachusetts Eye and Ear Infirmary. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-31.
Sponsored by Massachusetts Eye and Ear Infirmary · Phase 1, Interventional, and Treatment
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.
40 studies on the registry are indexed under Stevens-Johnson Syndrome; 8 are open to participants now.
This study's planned enrollment of 8 is below the median of 20 across 24 interventional studies indexed under Stevens-Johnson Syndrome.
Browse Stevens-Johnson Syndrome studies →Massachusetts Eye and Ear Infirmary is the lead sponsor of 100 studies on the registry; 23 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 7 (54%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Any of the following baseline lab values
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This arm will receive the study intervention.
Drug: Adalimumab Injection
10% (4.0mg/0.04ml) dissolved in sterile saline to be injected once during the time of the Boston Keratoprosthesis (Kpro) Surgery.
Also known as: Humira
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
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
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Jun 2027, 8 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Adalimumab
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