Subconjunctival Humira for Boston Keratoprosthesis

Starting soon · Phase 1

Conditions studied: Penetrating Keratoplasty, Multiple Graft Failure, Ocular Cicatricial Pemphigoid, Stevens-Johnson Syndrome

In brief

This trial is studying the safety and tolerability of receiving an injection of adalimumab (Humira) during the Boston Keratoprosthesis (KPro) surgery.

Key facts

Study ID

NCT06926478

Run by

Massachusetts Eye and Ear Infirmary

People needed

8

Starts

2026-06-01

Expected to finish

2028-06-01

Last updated by the study team

2026-03-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• Pregnancy (positive pregnancy test) or lactating
• Participation in another interventional study at the time of screening
• Any of the following baseline lab values
• White blood count <3500 cells per microliter
• Platelets <100,000 per microliter
• Hematocrit <30%
• AST or ALT >1.5X upper limit normal value
• Multiple sclerosis or other demyelinating disease
• Severe uncontrolled infection
• Moderate to severe heart failure (NYHA class III/IV)
• Active malignancy
• History of adalimumab intolerance
• Pregnancy or lactation
• Medical problems or drug or alcohol dependence problems sufficient to prevent adherence to treatment and study procedures.
• As judged by the investigator any patients that are questionable for their suitability in the study

Where it is running

• Massachusetts Eye and Ear — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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