Subconjunctival Humira for Boston Keratoprosthesis

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Stevens-Johnson Syndrome; Ocular Cicatricial Pemphigoid; Penetrating Keratoplasty; Multiple Graft Failure
• Intervention / Treatment: Drug: Adalimumab Injection

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.

• Study Type: Interventional
• Enrollment (Estimated): 8
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Michael Cheung, MSc, CCRP; Phone Number: 617-573-6060; Email: mcheung0@meei.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts Eye and Ear
      • Contact: Michael Cheung, MSc, CCRP; Phone Number: 6175736060; Email: mcheung0@meei.harvard.edu
      • Principal Investigator: Thomas Dohlman, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Adalimumab (Humira); This arm will receive the study intervention.	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.; Other Names: Humira

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of Treatment Related Adverse Events.	To evaluate safety following subconjunctival injection of adalimumab at the time of keratoprosthesis surgery in patients who have corneal problems of such severity that they require keratoprosthesis implantation. The incidence, severity, and duration of adverse events will be assessed and documented. Because the subjects in this study have corneal problems of such severity that they require keratoprosthesis implantation, special attention will be given to adverse events of particular concern, such as microbial keratitis, subconjunctival hemorrhage, subconjunctival inflammation, or retinal necrosis or retinal detachment	30 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of adalimumab Injection though changes in visual acuity.	This efficacy outcome measure will be analyzed though changes of any worsening of the best corrective visual acuity by 15 letters at every study visit.	30 Days
Efficacy of adalimumab Injection though changes in Optic Nerve Cup-to-Disk Ratio	This efficacy outcome measure will be analyzed through any changes to the cup-to-disk ratio. A normal ratio is 0.2mm	Every Two (2) Weeks After Implantation/Injection until Day 30
Efficacy of adalimumab Injection through incidences of Intraocular Inflammation	This efficacy outcome measure will be analyzed though any incidences of intraocular inflammation that occurs post implantation/injection.	30 Days
Efficacy of adalimumab Injection through changes in the Ocular Coherence Tomography (OCT) of the Optic Nerves	This efficacy outcome measure will be analyzed though any changes in the retinal nerve fiber layer thickness (nerve edema).	30 Days
Efficacy of adalimumab Injection though changes in the ocular coherence tomography (OCT) of the Retina	This efficacy outcome measure will be analyzed though increases in the foveal retinal thicknesses by an increase of more than (>)100um in comparison to the previous study visit(s).	30 Days

Collaborators and Investigators

• Sponsor: Massachusetts Eye and Ear Infirmary
• Investigators: Principal Investigator: Thomas Dohlman, MD, Massachusetts Eye and Ear

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: March 25, 2025
• First Submitted That Met QC Criteria: April 7, 2025
• First Posted (Actual): April 13, 2025

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 23, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Keratoprosthesis; Kpro; Boston Kpro; Type-1 Boston Kpro
• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Immune System Diseases; Eye Diseases; Hypersensitivity; Chemically-Induced Disorders; Skin Diseases; Drug-Related Side Effects and Adverse Reactions; Conjunctival Diseases; Skin Diseases, Vesiculobullous; Hypersensitivity, Delayed; Dermatitis; Erythema; Drug Eruptions; Drug Hypersensitivity; Stomatitis; Erythema Multiforme; Skin and Connective Tissue Diseases; Stevens-Johnson Syndrome; Pemphigoid, Benign Mucous Membrane; Amino Acids, Peptides, and Proteins; Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Adalimumab
• Other Study ID Numbers: 2025P000846

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No