Subconjunctival Humira for Boston Keratoprosthesis

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts Eye and Ear Infirmary

About this trial

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

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Adalimumab Injection

Treatment groups

8 Participants
are divided into 1 treatment group