Clinical trial NCT06926478: Subconjunctival Humira for Boston Keratoprosthesis
Official title: Clinical Trial to Evaluate Short-term Safety of Subconjunctival Adalimumab in Combination With Type 1 Boston Keratoprosthesis Implantation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Penetrating Keratoplasty
Multiple Graft Failure
Ocular Cicatricial Pemphigoid
Stevens-Johnson Syndrome
Keywords: Kpro
Boston Kpro
Keratoprosthesis
Type-1 Boston Kpro
Lead sponsor: Massachusetts Eye and Ear Infirmary
Sponsor class: OTHER
First posted: 2025-04-13
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

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

Primary outcomes:
measure: Evaluation of Treatment Related Adverse Events.
timeFrame: 30 Days
Secondary outcomes:
measure: Efficacy of adalimumab Injection though changes in visual acuity.
timeFrame: 30 Days
measure: Efficacy of adalimumab Injection though changes in Optic Nerve Cup-to-Disk Ratio
timeFrame: Every Two (2) Weeks After Implantation/Injection until Day 30
measure: Efficacy of adalimumab Injection through incidences of Intraocular Inflammation
timeFrame: 30 Days
measure: Efficacy of adalimumab Injection through changes in the Ocular Coherence Tomography (OCT) of the Optic Nerves
timeFrame: 30 Days
measure: Efficacy of adalimumab Injection though changes in the ocular coherence tomography (OCT) of the Retina
timeFrame: 30 Days
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts Eye and Ear
state: Massachusetts
Study officials:
affiliation: Massachusetts Eye and Ear
name: Thomas Dohlman, MD
role: PRINCIPAL_INVESTIGATOR
References: