Subconjunctival Humira for Boston Keratoprosthesis

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts Eye and Ear Infirmary
Study ID
NCT06926478
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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

Key Dates

Start date
Jun 1, 2026
Status verified
Mar 2026
Primary completion
Jun 1, 2027
Completion
Jun 1, 2028

Study Design

Enrollment
8 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Adalimumab (Humira)
    This arm will receive the study intervention.

Primary Outcome Measure

Evaluation of Treatment Related Adverse Events. [ Time Frame: 30 Days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts Eye and EarBostonMassachusetts02114
Michael Cheung, MSc, CCRP
[email protected]
6175736060
Thomas Dohlman, MD (PRINCIPAL_INVESTIGATOR)

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Massachusetts Eye and Ear· Boston, MA