Status:
NOT_YET_RECRUITING
Subconjunctival Humira for Boston Keratoprosthesis
Lead Sponsor:
Massachusetts Eye and Ear Infirmary
Conditions:
Penetrating Keratoplasty
Multiple Graft Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This trial is studying the safety and tolerability of receiving an injection of adalimumab (Humira) during the Boston Keratoprosthesis (KPro) surgery.
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2028
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT06926478
Start Date
August 1 2025
End Date
August 1 2028
Last Update
April 13 2025
Active Locations (1)
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1
Massachusetts Eye and Ear
Boston, Massachusetts, United States, 02114