Who is eligible for clinical trial NCT06926478?

Participants must meet protocol criteria for Penetrating Keratoplasty. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT06926478 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-03-23

Subconjunctival Humira for Boston Keratoprosthesis (NCT06926478)

🟡 Not Yet Recruiting Phase1 💊 Investigational Drug / Biologic Sponsor: Massachusetts Eye and Ear Infirmary

🩺 Plain-English Summary (8th-Grade Level)

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

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (20 items).

Location: Massachusetts Eye and Ear — Boston, Massachusetts

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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

Usually NOT eligible if any of the following apply:

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
White blood count \<3500 cells per microliter
Platelets \<100,000 per microliter
Hematocrit \<30%
AST or ALT \>1.5X upper limit normal value

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

Massachusetts Eye and Ear — Boston, Massachusetts

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗