Subconjunctival Humira for Boston Keratoprosthesis

Launched by MASSACHUSETTS EYE AND EAR INFIRMARY · Apr 7, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating the safety and how well patients tolerate an injection of adalimumab (known as Humira) during a specific eye surgery called the Boston Keratoprosthesis (KPro). This surgery is often recommended for patients who have severe eye problems, such as multiple failed corneal transplants, certain eye diseases, or conditions that cause scarring of the eye. The trial is currently not recruiting participants, but it is designed for adults aged 18 and older who have very poor vision in one eye and worse vision in the other eye, among other criteria.

To be eligible for this study, participants must be suitable for the KPro surgery and willing to follow the study plan completely. They should not have certain health issues, like active infections or cancer, and must not be pregnant or breastfeeding. If you join the trial, you can expect to receive the injection during your surgery and will be monitored closely for any side effects or complications. It’s important to talk to your doctor about this study if you think you might qualify or have questions!

Gender

ALL

Eligibility criteria

• 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 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
• • 1. White blood count \<3500 cells per microliter
• • 2. Platelets \<100,000 per microliter
• • 3. Hematocrit \<30%
• • 4. 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