Subconjunctival Humira for Boston Keratoprosthesis

Mass Eye and Ear

Status and phase: Not yet enrolling; Phase 1

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

Treatments: Drug: Adalimumab Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT06926478

2025P000846

Details and patient eligibility

About

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

Full 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 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.

Enrollment: 8 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

Adalimumab (Humira)

Experimental group

Description:

This arm will receive the study intervention.

Treatment:

Drug: Adalimumab Injection