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Not yet recruiting NCT06926478

Subconjunctival Humira for Boston Keratoprosthesis

Phase I Interventional Penetrating Keratoplasty Multiple Graft Failure Ocular Cicatricial Pemphigoid Stevens-Johnson Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Adalimumab Injection.
Who it may be relevant to
Registry conditions: Penetrating Keratoplasty, Multiple Graft Failure, Ocular Cicatricial Pemphigoid, Stevens-Johnson Syndrome. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Clinical Trial to Evaluate Short-term Safety of Subconjunctival Adalimumab in Combination With Type 1 Boston Keratoprosthesis Implantation

Overview

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.

Interventions

  • Drug Adalimumab Injection
    10% (4.0mg/0.04ml) dissolved in sterile saline to be injected once during the time of the Boston Keratoprosthesis (Kpro) Surgery.

Primary outcome measures

  • Evaluation of Treatment Related Adverse Events. [Time frame: 30 Days]
Secondary outcome measures (5)
  • Efficacy of adalimumab Injection though changes in visual acuity. [Time frame: 30 Days]
  • Efficacy of adalimumab Injection though changes in Optic Nerve Cup-to-Disk Ratio [Time frame: Every Two (2) Weeks After Implantation/Injection until Day 30]
  • Efficacy of adalimumab Injection through incidences of Intraocular Inflammation [Time frame: 30 Days]
  • Efficacy of adalimumab Injection through changes in the Ocular Coherence Tomography (OCT) of the Optic Nerves [Time frame: 30 Days]
  • Efficacy of adalimumab Injection though changes in the ocular coherence tomography (OCT) of the Retina [Time frame: 30 Days]

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
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Massachusetts Eye and Ear — Boston

Identifiers

NCT: NCT06926478 · 2025P000846

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗