Subconjunctival Humira for Boston Keratoprosthesis

NCT ID: NCT06926478

Last Updated: 2025-04-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2028-08-01

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Adalimumab (Humira)

This arm will receive the study intervention.

Group Type: EXPERIMENTAL

Adalimumab Injection

Intervention Type: DRUG

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

Interventions

Adalimumab Injection

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

Intervention Type: DRUG

Other Intervention Names

Humira

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts Eye and Ear Infirmary

OTHER

Sponsor Role: lead

Responsible Party

Thomas H. Dohlman, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thomas Dohlman, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts Eye and Ear

Locations

Massachusetts Eye and Ear

Boston, Massachusetts, United States

Countries

United States

Central Contacts

Michael Cheung, MSc, CCRP

Role: CONTACT

MCHEUNG0@MEEI.HARVARD.EDU

617-573-6060

Facility Contacts

Michael Cheung, MSc, CCRP

Role: primary

MCHEUNG0@MEEI.HARVARD.EDU

617-573-6060

Other Identifiers

2025P000846

Identifier Type: -

Identifier Source: org_study_id