Subconjunctival Humira for Boston Keratoprosthesis

NCT06926478 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: 2025P000846
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

Kpro; Boston Kpro; Keratoprosthesis; Type-1 Boston Kpro

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Efficacy of adalimumab Injection though changes in visual acuity.

  30 Days

• Efficacy of adalimumab Injection though changes in Optic Nerve Cup-to-Disk Ratio

  Every Two (2) Weeks After Implantation/Injection until Day 30

• Efficacy of adalimumab Injection through incidences of Intraocular Inflammation

  30 Days

• Efficacy of adalimumab Injection through changes in the Ocular Coherence Tomography (OCT) of the Optic Nerves

  30 Days

• Efficacy of adalimumab Injection though changes in the ocular coherence tomography (OCT) of the Retina

  30 Days

Study Arms (1)

Adalimumab (Humira)

EXPERIMENTAL

This arm will receive the study intervention.

Drug: Adalimumab Injection

Interventions

Adalimumab Injection DRUG

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

Also known as: Humira

Adalimumab (Humira)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts Eye and Ear Infirmary: lead

Study Sites (1)

Massachusetts Eye and Ear

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Pemphigoid, Benign Mucous Membrane; Stevens-Johnson Syndrome

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Conjunctival Diseases; Eye Diseases; Skin Diseases, Vesiculobullous; Skin Diseases; Skin and Connective Tissue Diseases; Stomatitis; Mouth Diseases; Stomatognathic Diseases; Drug Eruptions; Dermatitis; Erythema Multiforme; Erythema; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases; Drug Hypersensitivity; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Thomas Dohlman, MD

  Massachusetts Eye and Ear

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Cheung, MSc, CCRP

CONTACT

617-573-6060; MCHEUNG0@MEEI.HARVARD.EDU

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: April 13, 2025
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)